0747 transanal endoscopic microsurgery (1)...oct 15, 2019 · aetna considers transanal endoscopic...

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Transanal Endoscopic Microsurgery

Clinical Policy Bulletins Medical Clinical Policy Bulletins

Number: 0747

*Please see amendment for Pennsylvania Medicaid at the end of this CPB.

Aetna considers transanal endoscopic microsurgery (TEM) medically necessary for the following

indications:

Benign rectal tumors (adenomas)

Low-risk Tis and T1 rectal carcinoma

Small rectal carcinoids (less than 2 cm in diameter).

Aetna considers TEM experimental and investigational for all the following indications (not an all-

inclusive list) because its effectiveness for indications other than the ones listed above has not

been established:

Advanced rectal cancer

Anorectal melanoma

Benign rectal strictures

Functional constipation

Giant villous adenoma of rectum

Megacolon

Rectal amyloidoma

Rectal gastro-intestinal stromal tumor (GIST)

Rectal neuroendocrine tumor in advanced stages or with metastasis

Rectal prolapse and diverticula

Last Review

10/15/2019

Effective: 02/08/2008

Next

Review: 08/13/2020

Review

History

Definitions

Additional

Clinical Policy

Bulletin

Notes

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Rectal ulcer syndrome

Recto-urinary fistula (e.g., recto-urethral fistula)

Recto-vesical fistula

Retro-rectal (pre-sacral) tumors.

Background

Rectal cancers, most of which are adenocarcinomas, affect more than 40,000 people in the

United States each year. Rectal cancers can be classified by the tumor, node, metastasis (TNM)

system, which was introduced by the American Joint Committee on Cancer and the International

Union Against Cancer. The TNM classification is an universal staging system for all

solid tumors, and is based on clinical and pathological information (Cirincione and Cagir, 2007):

Primary Tumor (T):

TX - Primary tumor can not be assessed or depth of penetration not specified

T0 - No evidence of primary tumor

Tis - Carcinoma in-situ (mucosal); intra-epithelial or invasion of the lamina propria

T1 - Tumor invades submucosa

T2 - Tumor invades muscularis propria

T3 - Tumor invades through the muscularis propria into the subserosa or into non

peritonealized peri-colic or peri-rectal tissue

T4 - Tumor directly invades other organs or structures and/or perforates the visceral

peritoneum

Regional Lymph Nodes (N):

NX - Regional lymph nodes can not be assessed

N0 - No regional lymph node metastasis

N1 - Metastasis in 1 to 3 peri-colic or peri-rectal lymph nodes

N2 - Metastasis in 4 or more peri-colic or peri-rectal lymph nodes

N3 - Metastasis in any lymph node along the course of a named vascular trunk

Distant Metastasis (M):

MX - Presence of metastasis can not be assessed

M0 - No distant metastasis

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M1 - Distant metastasis

According to the National Cancer Institute (2007), rectal cancers can also be classified as Stage

0 to Stage IV.

Stage 0: Abnormal cells are found in the innermost lining of the rectum. These abnormal

cells may become cancer and spread into nearby normal tissue. Stage 0 is also called

carcinoma in- situ

Stage I: Cancer has formed and spread beyond the innermost lining of the rectum to the 2nd

and 3rd layers and involves the inside wall of the rectum, but it has not spread to the outer

wall of the rectum or outside the rectum. Stage I rectal cancer is sometimes called Dukes A

rectal cancer.

Stage II: Cancer has spread outside the rectum to nearby tissue, but it has not gone into the

lymph nodes. Stage II rectal cancer is sometimes called Dukes B rectal cancer.

Stage III: Cancer has spread to nearby lymph nodes, but it has not spread to other parts of

the body. Stage III rectal cancer is sometimes called Dukes C rectal cancer.

Stage IV: Cancer has spread to other parts of the body (e.g., the liver, lungs, or ovaries).

Stage IV rectal cancer is sometimes called Dukes D rectal cancer.

Despite recent advances in chemo-radiotherapy, surgery still plays an important role in the

curative treatment for rectal cancers. The choice of surgical intervention depends on the location

of the tumor, depth of rectal wall invasion, as well as clinical stage of the disease. Surgical

options include local excision such as transanal excision and transanal endoscopic microsurgery

(TEM), and radical resection such as low anterior resection, extended low anterior resection with

colo-anal anastomosis, abdomino-perineal resection (APR), as well as pelvic exenteration. If the

cancer is found in a polyp, a polypectomy can be performed. Many considerations (e.g.,

morbidity, sexual and urinary dysfunction, and/or risk of definitive stoma) have led to the

increased popularity of local excision in the management of patients with rectal cancer.

However, its role as a curative treatment is still controversial with oncological long-term results

lower than those obtained by radical resection (Rajput and Bullard Dunn, 2007; Bretagnol et al,

2007a).

Currently, TEM is the only endoscopic technique that uses a natural opening to reach the target

organ, and is a valuable surgical technique with a low complication rate for patients with early

rectal cancer. The main advantage of TEM is preservation of the rectum. Other advantages

include better exposure, magnified stereoscopic view, and greater reach into the middle and

upper rectum. This procedure was introduced in the early 1980s; its first indication was excision

of rectal adenomas. Indication for TEM was later extended to low-risk rectal cancer. Many



studies reported that TEM is the optimal procedure to avoid complications for patients with rectal

polyps and low-risk pathological T1 (pT1) rectal tumors (Burghardt and Buess, 2005; Whiteford,

2007).

Araki et al (2003) discussed their experience with video-assisted gasless TEM (V-TEM) as a

means of local excision of rectal cancer. A total of 217 patients, with a mean follow-up of 61

months, underwent V-TEM for adenoma (n = 102), Tis (n = 83), T1 (n = 28), and T2 (n = 4) rectal

tumors, located 3 to 20 cm from the dentate line. The mean size of the tumor was 39 mm, and

the mean duration of the operation was 63 mins including set-up time, and the mean duration of

hospital stay was 5.8 days. Seven (3.2 %) patients underwent conversion to radical resection

owing to T1 with massive invasion or T2 tumors histopathologically. Two (0.9 %) patients had

recurrent disease that was managed by repeat V-TEM. The post-operative course in all patients

was free from any significant complications. Transient fecal soiling was present in 12 (5.5 %)

patients. The authors concluded that V-TEM was a safe, simple and minimally invasive

procedure for benign and early cancer in the proximal rectum.

In a retrospective review, Floyd and Saclarides (2006) reported that TEM treatment of pT1 rectal

cancers is safe and achieved low local recurrence and high survival rates. Patient age, gender,

tumor distance from the anal verge, lesion size, operative time, blood loss, complications,

recurrence, and survival rates were prospectively recorded. A total of 53 patients (26 men and

27 women, average age of 65.6 years, range of 31 to 89 years) were studied. Average tumor

distance from the anal verge was 7 cm (range of 0 to 13 cm); average size was 2.4 cm (range

of 1 to 10 cm). Radiation and/or chemotherapy were not administered. A total of 16 patients had

pT1 lesions removed piecemeal during colonoscopy; there was no residual tumor after TEM of

the polyp site. Mean follow-up was 2.84 years; 51 % of subjects had longer than 2-year follow-

up. For the entire group, there were 4 recurrences (7.5 %) occurring at 9 months, 15 months, 16

months, and 11 years. Two were treated with APR, one with low anterior resection, and one with

fulguration alone. There were no recurrences in the 16 patients who had excision of the

polypectomy site. If excluded, recurrence was 11 % (4/37). Patients were examined at 3-month

intervals for the first 2 years and every 6 months thereafter. There have been no cancer-related

deaths. The authors concluded that TEM of pT1 rectal cancers yielded low recurrence rates.

Lin et al (2006) compared local excision of early rectal tumors by TEM and the conventional

posterior trans-sphincteric approach (Mason's operation). The study group comprised 31

consecutive patients with early rectal tumors (18 villous adenomas, 13 adenocarcinomas) who

underwent TEM. The control group consisted of 51 patients with early rectal tumors (27 villous

adenomas, 24 adenocarcinomas) who underwent the Mason's operation. Outcome measures

included morbidity and mortality, operation time, recurrence rate, and post-operative pathological

staging. Age, sex, as well as pathological staging were similar in both groups. The tumor size,



operation time, and blood loss were similar. The m edian distance from the anal verge was

significantly higher in the TEM group (TEM/Mason = 8.0/6.4 cm, p = 0.042). The post-operative

resumption of food intake (TEM/Mason = 1/5 days, p = 0.002) and the median hospital stay

(TEM/Mason = 4/10 days, p = 0.005) were significantly shorter in the TEM group. Analgesic

intake was significantly less in the TEM group (TEM/Mason = 0/100 mg, p = 0.0003). There was

no operation-related mortality and the resection margins were clear in both groups. Two patients

(3.9 %) in the Mason's group developed post-operative wound infection, and 2 patients (3.9 %)

developed fecal fistulae. There was one secondary hemorrhage in the TEM group that required

injection sclerotherapy. On median follow-up of 23 months, there was no tumor recurrence in the

TEM group, whereas 2 patients (3.9 %) in the Mason's group experienced recurrence during a

median follow-up of 30 months. The authors concluded that TEM is as effective as the

conventional Mason's operation for local curative excision of early rectal tumors. It is less

invasive, with shorter hospital stay and fewer complications than the conventional Mason's

operation.

Borschitz and associates (2006) determined the prognostic factors for recurrences and the need

for re-operation in patients who had undergone local excision of early rectal cancer. In 105 of

118 patients with pT1 rectal carcinomas and local excision, recurrence rates as well as 10-year

cancer-free survival rates were studied separately according to different histological criteria (R0,

R1, Rx, R less than or equal to 1 mm, high-risk/low-risk situation), tumor localization (anterior,

posterior, lateral wall, and third of rectum), size, and degree of resection (full-thickness/partial

wall). Patients were grouped into local excision (n = 89) and local excision followed by re-

operation (n = 21). Risk classification was performed by division into "low-risk" carcinomas after

local R0-resection (group A) and unfavorable histological results after local resection (R1, Rx,

R less than or equal to 1 mm, high-risk situation; group B). Local recurrence rate after local R0

resection of low-risk carcinomas (group A) was 6 %, whereas that for patients in group B with

local resection was 39 %. The recurrence risk in those patients was significantly reduced to 6 %

by re-operation (p = 0.015). In addition, the 10-year cancer-free survival rate was 93 % in group

B after re-operation compared with that of 89 % in patients of group A after local excision alone.

The authors concluded that local R0-resection in cases with low-risk pT1 carcinomas represents

an oncologically adequate therapy, which resulted in similar survival rates compared with primary

radical surgery of pT1N0M0 rectal carcinomas. High recurrence rates are observed in tumors

with unfavorable histological result (group B) requiring further treatment. In these cases

immediate re-operation lowered the recurrence rate to 6 %.

On the other hand, the same group of investigators reported that local R0 resection of low-risk

pT2 carcinomas represents an inadequate therapy (Borschitz et al, 2007). These researchers

examined the value of local excision for T2 rectal carcinomas, prognostic factors, and the need

for re-operation. After local excision of 649 patients with rectal tumors, pT2 carcinoma was



found in 44 patients. In general, immediate re-operation was recommended; however, 24

patients declined further surgery or were not re-operated because of co-morbidities. Results

were analyzed separately for local R0 resection of low-risk carcinomas and for prognostically

unfavorable criteria (R1/RX/R less than or equal to 1 mm/G3-4/L1/V1). Re-operation was

performed within 4 weeks. Recurrences also were divided by previous local R0 resection of low-

risk tumors as well as by unfavorable results, and were analyzed in a long-term, follow-up study.

Patients with palliative therapy were excluded, and follow-up was obtained in 90 % (20 TEM

alone, 17 TEM and re-operation). Local recurrence rate after local R0 resection alone of low-risk

T2 carcinomas was 29 %, whereas patients with unfavorable criteria developed recurrences in

50 %. After immediate re-operation, the local recurrence risk in patients without lymph node

filiae was significantly reduced to 7 %. The authors concluded that local R0 resection of low-risk

pT2 carcinomas represents an inadequate therapy.

In a prospective study, Maslekar et al (2007) presented their findings of patients with rectal

cancers managed by TEM. A total of 52 patients (22 women and 30 men) underwent TEM

excision of a rectal cancer. Their mean age was 74.3 years (range of 48 to 93 years). The

median diameter of the lesions was 3.44 cm (range of 1.6 to 8.5 cm). The median distance of

the lesions from the anal verge was 8.8 cm (range of 3 to 15 cm), with the tumor more than 10

cm from the anal verge in 36 patients. The median operating time was 90 minutes (range of 20

to 150 minutes), and the median post-operative stay was 2 days. All patients underwent full-

thickness excisions. There were 11 minor complications, 2 major complications, and no deaths.

The mean follow-up period was 40 months (range of 22 to 82 months). None of the pT1 rectal

cancers received adjuvant therapy. Eight patients with pT2 rectal cancer and 2 patients with pT3

rectal cancer received post-operative adjuvant therapy. The overall local rate of recurrence was

14 %, and involved cases of T2 and T3 lesions, with no recurrence after excision of T1 cancers.

Three patients died during the follow-up period, but no cancer-specific deaths occurred. The

authors concluded that TEM is a safe and effective treatment for selected cases of rectal cancer,

with low morbidity and no mortality.

Zacharakis and co-workers (2007) described a single institution's experience in the use of TEM

for rectal tumors. Between 1996 and 2005, TEM was performed in 76 patients (n = 28 for

adenocarcinoma; n = 48 for adenoma). Clear resection margins were achieved in 71 of 74

patients (95.9 %). Overall morbidity was 18.9 % because 14 patients developed minor (n = 10)

or major (n = 4) complications. During follow-up, benign tumor recurrence was detected in 3

patients (6.3 %). The recurrence rates among patients with T1, T2, and T3 malignant tumors

were 7.1 %, 42.8 %, and 66.6 %, respectively. The authors concluded that TEM is a safe and

feasible technique with low incomplete excision rates and may be the preferred method in

patients with benign rectal tumors. However, its role in the management of malignant tumors

should be limited to selected patients with T1 lesions.



Bretagnol and colleagues (2007b) ascertained the morbidity and long-term results of rectal

tumors excised by TEM. A total of 200 patients underwent TEM for excision of adenomas (n =

148) or carcinomas (n = 52). The median tumor distance from the anal verge was 8 cm (range

of 1 to 16 cm). Morbidity and mortality rates were 14.0 % and 0.5 %, respectively. At a median

follow-up of 33 months (range of 2 to 133 months), local recurrence had developed in 11 patients

(7.6 %) with an adenoma. Histological examination of carcinomas revealed pT1 in 31 patients,

pT2 in 17 and pT3 in 4. Immediate salvage surgery was performed in 7 patients (13 %). At a

median follow-up of 34 months (range of 1 to 102 months), 8 patients (15 %) with carcinomas

had developed local recurrence. The overall as well as disease-free 5-year survival rates for

patients with carcinomas were 76 % and 65 %, respectively. The authors concluded that TEM is

an appropriate surgical treatment option for benign rectal tumors. For carcinomas, it is

oncologically safe provided that resection margins are clear, but strict patient selection is

needed.

Many reviews, technology assessments, and clinical practice guidelines/parameters have

recommended local excision/TEM in the management of patients with early rectal cancer.

The Australian Medical Services Advisory Committee's assessment on TEM (2003) stated

that this procedure is primarily used for removal of certain lower and upper rectal tumors, such

as adenomas and carcinomas. Patients with small or early benign or early malignant tumors of

the rectum that can not be removed by colonoscopy are candidates for this surgery. The

procedure may also be used on patients who are unwilling or unable to undergo conventional

open surgery.

The American Society of Colon and Rectal Surgeons' practice parameters for the management

of rectal cancer (Tjandra et al, 2005) stated that local excision of rectal cancer is an appropriate

alternative therapy for selected cases of rectal cancer with a low likelihood of nodal metastases.

This probability is dependent on the depth of tumor invasion (T stage), tumor differentiation, and

lympho-vascular invasion. Comparative trials to APR supported transanal local excision with

curative intent for T1, well-differentiated cancers that are less than 3 cm in diameter and occupy

less than 40 % of the circumference of the rectal wall. Furthermore, the tumor must be excised

intact by full-thickness excision with clear margins. It should be orientated and pinned out for

complete pathological examination. If unfavorable features are observed on pathological

examination, a radical resection is warranted.

An assessment by the Canadian Agency for Drugs and Technologies in Health (Keay and

Farrah, 2008) concluded that the evidence suggests that TEM is effective and safe in removing

adenomas and T1 carcinomas when compared to local or radical resection. The

assessment stated that one study noted the local recurrence rate was higher for TEM compared



to resection, possibly because of lymphatic involvement; however, there was no difference in

long term survival between TEM and resection. The assessment noted that, overall, the

recurrence rates for adenomas and carcinomas were low, provided the resection margins are

clear and the lesions are not removed in a piecemeal fashion. The assessment found that the

most common complications of TEM include bleeding (which may be related to lesion location

and surgeon experience), urinary retention and temporary incontinences. Two functional quality

studies demonstrated that there was an overall good bowel function response with TEM. The

assessment reported that studies that have examined the costs of TEM have shown it to be a

cost-saving procedure when compared to radical resection, primarily because of the shorter

procedure time and hospital stay.

Serra Aracil et al (2006) stated that TEM-associated morbidity is low and mortality is practically

nil. It is the technique of choice in large rectal adenomas and malignant rectal tumors in stage

pT1 localized in the rectal ampulla. The frequency of recurrence is similar to that in abdominal

surgery. The technique does not cause complications of urinary or sexual dysfunction, and fecal

incontinence is minimal. In more advanced stages of rectal cancer, the results of better patient

selection and future studies on the possible application of neo-adjuvant therapy associated with

TEM are required.

Papagrigoriadis (2006) stated that TEM is an useful minimally invasive technique for the

treatment of certain large or sessile adenomas of the rectum. It can successfully treat those

adenomas that are unamenable to colonoscopic excision and can spare some patients the risks

and adverse effects of major rectal surgery. In case of malignant transformation or recurrence,

TEM can be used as first line treatment since it does not preclude radical resection, and can be

repeated for treating recurrences.

Helgstrand et al (2007) noted that the sue of TEM in the treatment of benign as well as T1

rectum tumors has become more widespread. These researchers presented their findings on 74

patients who underwent this procedure. A total of 49 patients had adenomas; both the

recurrence and complication rate was 6 %. Median follow-up period was 12 months (range of 0

to 57 months). Fifteen patients had a T1 tumor removed; the recurrence rate was 15 %. One

had a serious complication. Median follow-up period was 12 months (range of 3 to 36 months).

Eight had a T2 tumor removed; the recurrence rate was 16 %. One had a serious complication.

Median follow-up period was 21 months (range of 9 to 36 months). Two patients were treated for

a T3 tumor as part of palliation. The authors concluded that their results are comparative to the

largest foreign data. The recurrence rate is on the same level as open as well as laparoscopic

surgery and far less than traditional transanal surgery. The complication risks are on the same



level as laparoscopic access and far less than open surgery. However, pre-operative

investigation has to be developed further. Research is needed to clarify if selected patients with

T2 cancer could be treated with TEM in combination with radiotherapy.

Rokke et al (2007) stated that TEM is a safe and suitable method for resection of rectal

adenomas that can not be radically removed by endoscopic methods. It offers lower recurrence

rates and less morbidity than traditional treatment. Selected malignant tumors (e.g., small

carcinoid tumors and early stage [Tis, T1] adencarcinomas) with higer moderate differentiation

may be resected by TEM with the same oncological result as open surgery.

The National Cancer Institute's treatment option overview on rectal cancer (2007) stated that

surgery is the most common treatment for all stages of rectal cancer. Local excision is

recommended if the cancer is found at a very earlystage.

The progress report on the "1st Workshop on Local Excision of Rectal Cancer" that was held in

Germany (Borschitz and Junginger, 2007) noted that local excision of "low-risk" T1 carcinomas

was rated as oncologically adequate therapy with good functional results and low complication

rates. Transanal endoscopic microsurgery was the preferred technique. Pre-requisite for the

achievement of low recurrence rates (5 %) is an R0 resection with a safety margin of at least 1

mm (R less than or equal to 1 mm) without tumor fragmentation, because otherwise possible

tumor cell displacement and RX resection may not allow an assessment of the resection margin.

"High-risk" tumors or T2 carcinomas were not considered an indication for local excision.

The National Comprehensive Cancer Network's practice guideline on rectal cancer (2007) stated

that transanal excision may be appropriate for selected early stage cancers. Small (less than 3

cm), well-to-moderately differentiated T1 tumors that are within 8 cm of the anal verge and

limited to less than 30 % of the rectal circumference, and for which there is no evidence of nodal

involvement can be approached with a full-thickness excision with a 3-mm negative margin. An

alternative technique to full-thickness excision is TEM.

In summary, TEM has been shown to be safe and effective for resecting benign adenomas as

well as selected malignant tumors (e.g., small carcinoid tumors and early stage [Tis, T1]

adencarcinomas).

Baatrup and colleagues (2010) described 6 cases of management of rectal strictures by TEM.

Patients were placed in the lithotomy-Trendelenburg position and the stricture was resected from

4 to 8 o'clock through the entire thickness of the fibrosis. The upper resection edge was

mobilized including all layers of the rectal wall and the defect was sutured along the



circumference. Satisfactory anatomical and functional long-term results were obtained in 5 of 6

patients. The authors concluded that TEM resection of benign strictures is feasible in some

patients and should be tested in a randomized study against known procedures.

Rectal carcinoids are often inadequately resected by snare excision during colonoscopy.

Transanal endoscopic microsurgery offers full thickness excision with a low rate of negative

margins. It presents an excellent alternative to radical surgery for mid and proximally located

lesions.

Kinoshita et al (2007) evaluated the effectiveness of TEM in the treatment of rectal carcinoid

tumor. A total of 27 patients with rectal carcinoid tumor underwent TEM, and their clinical data

were reviewed retrospectively. The TEM procedure was performed as a primary excision (n =

14) or as completion surgery after incomplete resection by endoscopic polypectomy (n = 13).

The average size of a primary tumor was 9.1 mm (range of 5 to 13 mm), and the average

distance of the tumor from the anal verge was 8.5 cm. The mean duration of the operation was

51.6 mins. Minor morbidities, transient soilage, and mild dehiscence occurred in 2 cases (7.4

%). Histopathologically, all tumors were localized within the submucosal layer showing typical

histology without lymphatic or vessel infiltration, and both deep and lateral surgical margins were

completely free of tumors. Among 13 cases of completion surgery after endoscopic

polypectomy, 4 (30.8 %) were histologically shown to have a residual tumor in the specimens

obtained by TEM. No additional radical surgery was performed. The mean follow-up period was

70.6 months, and no recurrence was noted. The authors concluded that TEM is a safe,

minimally invasive procedure for the local excision of rectal carcinoid tumors, particularly those in

the proximal rectum. Furthermore, for patients with microscopic positive margins after

endoscopic polypectomy, TEM can be an effective surgical option for complete removal of

residual tumors.

Tsai et al (2010) reviewed their experience with TEM to clarify its role in the treatment of different

types of rectal pathology. A prospective database documented all patients undergoing transanal

endoscopic microsurgery from October 1996 through June 2008. These investigators analyzed

patient and operative factors, complications, and tumor recurrence. For recurrence

analysis, they excluded patients with fewer than 6 months of follow-up, previous excisions,

known metastases at initial presentation, and those who underwent immediate radical resection

following transanal endoscopic microsurgery. A total of 269 patients underwent TEM for benign

(n = 158) and malignant (n = 111) tumors. Procedure-related complications (21 %) included

urinary retention (10.8 %), fecal incontinence (4.1 %), fever (3.8 %), suture line dehiscence (1.5

%), and bleeding (1.5 %). Local recurrence rates for 121 benign and 83 malignant tumors were

5 % for adenomas, 9.8 % for T1 adenocarcinoma, 23.5 % for T2 adenocarcinoma, 100 % for T3

adenocarcinoma, and 0 % for carcinoid tumors. All 6 (100 %) recurrent adenomas were



retreated with endoscopic techniques, and 8 of 17 (47 %) recurrent adenocarcinomas underwent

salvage procedures with curative intent. The authors concluded that TEM is a safe and effective

method for excision of benign and malignant rectal tumors. It can be offered for (i) curative

resection of benign tumors, carcinoid tumors, and select T1 adenocarcinomas, (ii)

histopathological staging in indeterminate cases, and (iii) palliative resection in patients

medically unfit or unwilling to undergo radical resection.

Shields et al (2010) described recent experience with rectal carcinoids in European and North

American centers. Rectal carcinoid patients were identified from prospective databases

maintained at 9 institutions between 1999 and 2008. Demographic, clinical, and histological data

were collated. Median follow-up was 5 years (range of 0.5 to 10 years). A total of 202 patients

were identified. The median age was 55 years (range of 31 to 81 years). The majority of tumors

were an incidental finding (n = 115, 56.9 %). The median tumor size was 10 mm (range of 2 to

120 mm). Overall, 93 (49 %) tumors were limited to the mucosa or submucosa, 45 (24 %)

involved the muscularis propria, 29 (15 %) extended into the peri-rectal fat, and 6 (3 %) reached

the visceral peritoneum. The primary treatment modalities were endoscopic resection (n = 86,

43 %) and surgical extirpation (n = 102, 50 %). Forty-one patients (40 %) underwent a high

anterior resection, whereas 45 (44 %) underwent anterior resection with total mesorectal

excision. Seven patients (7 %) underwent Hartman's procedure, 7 (7 %) underwent abdomino

perineal resection, and 6 (6 %) had TEM, whereas 4 (4 %) patients underwent a transanal

excision. Multiple variable logistic regression analysis demonstrated that tumor size greater than

10 mm and lymphovascular invasion were predictors of nodal involvement (p = 0.006 and <

0.001, respectively), whereas the presence of lymph node metastases and lymphovascular

invasion was associated with subsequent development of distant metastases (p = 0.033 and

0.022, respectively). The presence of nodal metastases has a profound effect upon survival,

with a 5-year survival rate of 70 %, and 10-year survival of 60 % for node-positive tumors.

Patients with distant metastases have a 4-year survival of 38 %. The authors concluded that

tumor size greater than 10 mm and lymphovascular invasion are significantly associated with the

presence of nodal disease, rendering mesorectal excision advisable. Transanal excision is

adequate for smaller tumors.

Steinhagen et al (2011) performed a review of a prospectively maintained database of patients

scheduled for TEM. A total of 93 patients underwent 96 procedures for 13 carcinoid tumors, 1

submucosal mass, 46 adenomas, 12 in situ adenocarcinomas, and 21 invasive

adenocarcinomas. Of these cases, 81.2 % was successfully completed. There were 9

complications (11.5 %). Final pathology demonstrated 33 in situ and invasive adenocarcinomas.

The mean follow-up was 25.9 months. The 4 recurrences (12.1 %) occurred in: 1 tubulo-villous

adenoma, 2 in situ carcinomas, and 1 T2 lesion. The authors concluded that TEM is appropriate



for benign lesions such as carcinoid tumors and adenomas and can also be curative in carefully

selected patients with early-stage invasive rectal cancer. In cases of invasive adenocarcinoma,

it should be reserved for low-risk cancers in patients who accept the possible increased risk of

recurrence.

Kumar et al (2012) reported the largest American experience in the use of TEM for rectal

carcinoids. Data of patients having undergone TEM for rectal carcinoids were prospectively

collected and retrospectively analyzed. Patient and tumor characteristics, operative and peri

operative details, as well as oncological outcomes were reviewed. Over a 12-year period, 24

patients underwent TEM for rectal carcinoids. Of these, 6 (25 %) were primary surgical

resections and 18 (75 %) were done after incomplete snare excisions during colonoscopy. Three

patients (17 %) undergoing full-thickness resection after snare excision had residual tumor on

histopathological examination. Negative margins were obtained in all cases. No recurrences

were noted. The authors concluded that TEM is safe and effective for the surgical resection of

rectal carcinoids less than 2 cm in diameter, with typical features, and located more than 5 cm

from the anal verge. It can be used for primary resection or resection following inadequate

colonoscopic snare excision.

Ashraf et al (2012) stated that TEM for early rectal cancer (ERC) gives results similar to major

surgery in selected cases. Endorectal ultrasound (ERUS) is an important part of the pre

operative selection process. This study reported its accuracy and impact for patients entered on

the United Kingdom TEM database, which comprises prospectively collected data on 494

patients. This data set was used to determine the prevalence of ERUS in pre-operative staging

and its accuracy by comparing pre-operative T-stage with definitive pathological staging following

TEM. Endorectal ultrasound was performed in 165 of 494 patients who underwent TEM for

rectal cancer. It inaccurately staged rectal cancer in 44.8 % of tumors: 32.7 % were under-

staged and 12.1 % were over-staged. There was no significant difference in the depth of TEM

excision or R1 rate between the patients who underwent ERUS before TEM and those who did

not (p = 0.73). The authors concluded that these findings showed that ERUS is employed in a

minority of patients with rectal cancers undergoing TEM in the United Kingdom and its accuracy

in this "real world" practice is disappointing.

Morino et al (2013) stated that almost 30 years ago, TEM revolutionized the technique and

outcomes of transanal surgery, first becoming the standard of treatment for large rectal

adenomas, then offering a possibly curative treatment for early rectal cancer, and finally

generating discussion on its potential role in combination with neoadjuvant therapies for the

treatment of more invasive cancer. Transanal endoscopic microsurgery afforded the advantage

of combining a less invasive transanal approach with low recurrence rates thanks to enhanced

visualization of the surgical field, which allows more precise dissection. These investigators



described the current indications, the pre-operative work-up, the surgical technique (with the aid

of a video), post-operative management and results obtained in an over 20-year long

experience. Designed as an accurate means to allow excision of benign rectal neoplasms with a

very low morbidity rate, TEM today is indicated as a curative treatment of malignant neoplasms

that are histologically confirmed as pT1 sm1 carcinomas. The authors stated that T1 sm2-3 and

T2 lesions should at present be included in prospective trials. Accurate pre-operative staging is

essential for optimal selection of patients. Patients with clear indication for TEM should be

referred to specialized medical centers experienced with thetechnique.

The Standards Practice Task Force of the American Society of Colon and Rectal Surgeons’

practice parameters on “The management of rectal cancer (revised)” (Monson et al, 2013) stated

that “Local excision is an appropriate treatment modality for carefully selected T1 rectal cancers

without high-risk features. Local excision can be performed via transanal excision (Parks-type

excision) or with a transanal endoscopic microsurgery approach. The transanal endoscopic

microsurgery approach appears to be superior to the transanal approach in terms of visualization

and resection of higher lesions”.

Chen and colleagues (2013) compared the surgical and oncological effectiveness as well as

safety of TEMS and laparoscopic lower anterior resection (LAR) in T1-2 rectal cancer patients.

T1-2N0 rectal cancer patients were prospectively and randomly assigned to local excision using

TEMS (n = 30) or radical resection (RR) using LAR (n = 30). The primary outcome measures

were post-operative recovery course. The operative duration of TEMS was significantly shorter

than that of LAR (130.3 ± 16.7 minutes versus 198.7 ± 16.8 minutes, p < 0.01). The TEMS

group re-started bowel movement significantly earlier than the LAR group (51.4 ± 5.4 hours

versus 86.2 ± 8.7 hours, p < 0.01). The post-operative complications were mild and self-limited

in the 2 groups. Local recurrences occurred in 2 T2 patients (2/28, 7.1 %) at 8 months and 16

months following TEMS, respectively; no patient (0/30, 0.0 %) developed local recurrence

following LAR. The authors concluded that TEMS was associated with more rapid post

operative recovery and minimal surgical morbidity in T1-2 rectal cancer patients as compared to

LAR.

Sajid et al (2014) performed a systematic analysis of trials comparing the effectiveness of TEM

with RR for T1 and T2 rectal cancer. An electronic search was carried out of trials reporting the

effectiveness of TEM and RR in the treatment of T1 and T2 rectal cancers. A total of 10 trials

including 942 patients were retrieved. There was a trend toward a higher risk of local recurrence

(odds ratio [OR] 2.78; 95 % confidence interval [CI]: 1.42 to 5.44; z = 2.97; p < 0.003) and overall

recurrence (p < 0.01) following TEMS compared with RR. The risk of distant recurrence, overall

survival (OS) (OR 0.90; 95 % CI: 0.49 to 1.66; z = 0.33; p = 0.74) and mortality was similar.

Transanal endoscopic microsurgery was associated with a shorter operation time and hospital



stay and a reduced risk of post-operative complications (p < 0.0001). The included studies,

however, were significantly diverse in stage and grade of rectal cancer and the use of

neoadjuvant chemo-radiotherapy. The authors concluded that TEM appears to have clinically

measurable advantages in patients with early rectal cancer. The studies included in this review

do not allow firm conclusions as to whether TEM is superior to RR in the management of early

rectal cancer. They stated that larger, better designed and executed prospective studies are

needed to answer this question.

In a systematic review and meta-analysis, Arezzo et al (2014) compared the safety and

effectiveness of endoscopic submucosal dissection (ESD) and full-thickness rectal wall excision

by TEM in the treatment of large non-pedunculated rectal lesions pre-operatively assessed as

non-invasive. A systematic review of the literature published between 1984 and 2010 was

conducted (Registration no. CRD42012001882). Data were integrated with those from the

original databases requested from the study authors when needed. Pooled estimates of the

proportions of patients with en-bloc R0 resection, complications, recurrence, and need for further

treatment in the ESD and TEM series were compared using random-effects single-arm meta-

analysis. This review included 11 ESD and 10 TEM series (2,077 patients). The en-bloc

resection rate was 87.8 % (95 % CI: 84.3 to 90.6) for the ESD patients versus 98.7 % (95 % CI:

97.4 to 99.3 %) for the TEM patients (p < 0.001). The R0 resection rate was 74.6 % (95 % CI:

70.4 to 78.4 %) for the ESD patients versus 88.5 % (95 % CI: 85.9 to 90.6 %) for the TEM

patients (p < 0.001). The post-operative complications rate was 8.0 % (95 % CI: 5.4 to 11.8 %)

for the ESD patients versus 8.4 % (95 % CI: 5.2 to 13.4 %) for the TEM patients (p = 0.874).

The recurrence rate was 2.6 % (95 % CI: 1.3 to 5.2 %) for the ESD patients versus 5.2 % (95 %

CI: 4.0 to 6.9 %) for the TEM patients (p < 0.001). Nevertheless, the rate for the overall need of

further abdominal treatment, defined as any type of surgery performed through an abdominal

access, including both complications and pathology indications, was 8.4 % (95 % CI: 4.9 to 13.9

%) for the ESD patients versus 1.8 % (95 % CI: 0.8 to 3.7 %) for the TEM patients (p < 0.001).

The authors concluded that the ESD procedure appears to be a safe technique, but TEM

achieves a higher R0 resection rate when performed in full-thickness fashion, significantly

reducing the need for further abdominal treatment.

Fichera and Allaix (2014) stated that treatment of rectal cancer has dramatically evolved during

the last 3 decades shifting toward a tailored approach based on pre-operative staging and

response to neoadjuvant combined modality therapy (CMT). These investigators performed a

literature search using PubMed/Medline electronic databases. Selected patients with T1 N0

rectal cancer are best treated with local excision by TEM. Satisfactory results have been

reported after CMT and TEM for the treatment of highly selected T2 N0 rectal cancers.

Neoadjuvant CMT followed by rectal resection and total meso-rectal excision is considered the

standard of care for the treatment of locally advanced rectal cancer. However, a subset of stage



II and III patients may not require neoadjuvant radiation treatment. Finally, there are mounting

data supporting a "watch and wait" approach or local excision in patients with complete clinical

response after neoadjuvant CMT. The authors concluded that current evidence showed that

selected T1 N0 rectal cancers can be managed by TEM alone, while locally advanced cancers

should be treated by CMT followed by radical surgery. Studies are underway to identify patients

that do not benefit from neoadjuvant radiation therapy. A non-operative approach in case of

complete clinical response must be validated by large prospective studies.

The National Comprehensive Cancer Network’s clinical practice guideline on “Rectal cancer”

(Version 3.2014) indicates that TEMS may be used for transanal excision of rectal cancer when

the following criteria are met:

Less than 30 % circumference of bowel

Less than 3 cm in size

Margin clear (greater than 3 mm)

Mobile, non-fixed

With 8 cm of anal verge

T1 only

Endoscopically removed polyp with cancer or indeterminate pathology

No lympho-vascular invasion or peri-neural invasion

Well to moderately differentiated

No evidence of lymphadenopathy

Cunningham (2014) noted that there is increasing interest in organ-preserving options in the

management of rectal cancer. Excision of small, early stage cancers by TEM is an important part

of this approach. Carefully selected cancers can be treated successfully by TEM with acceptably

low risk of recurrent disease and overall cancer outcomes similar to radical surgery. The impact

of recurrence can be mitigated by early detection of luminal or nodal disease for which a robust

surveillance program is essential. However, patients with high risk features on post-TEM

pathology should be offered completion radical surgery that is associated with good oncological

results. There may be an opportunity to expand the population of patients who can be offered

rectal preservation with the use of radiotherapy in either adjuvant or neo-adjuvant context. Full

thickness excision by TEM may be particularly valuable in those demonstrating a clinical

complete response to radiotherapy, where diagnosis of complete pathological response can be

confirmed. The authors stated that the use of TEM in managing more advanced rectal cancers is

exciting, but must be tested within formal clinical trials before being adopted as routine practice.



Heidary et al (2014) stated that rectal adenomas and cancers occur frequently. Small adenomas

can be removed colonoscopically, whereas larger polyps are removed via conventional transanal

excision. Owing to technical difficulties, adenomas of the mid- and upper-rectum require radical

resection. Transanal endoscopic microsurgery was first designed as an alternative treatment for

these lesions. However, since its development, TEM has been also used for a variety of rectal

lesions, including carcinoids, rectal prolapse and diverticula, early stage carcinomas and

palliative resection of rectal cancers. These investigators described the current status of TEM in

the treatment of rectal lesions. Since the 1980s, TEM has advanced substantially. With low

recurrence rates, it is the method of choice for resection of endoscopically unresectable

adenomas. Some studies have shown benefits to its use in treating early T1 rectal cancers

compared with radical surgery in select patients. However, for more advanced rectal cancers

TEM should be considered palliative or experimental. This technique has also been shown to be

safe for the treatment of other uncommon rectal tumors, such as carcinoids.

Althumairi and Gearhart (2015) stated that the goal of treatment for early stage rectal cancer is

to optimize oncologic control while minimizing the long-term impact of treatment on quality of life

(QOL). The standard of care treatment for most stage I and II rectal cancers is radical surgery

alone, specifically total mesorectal excision (TME). For early rectal cancers, this procedure is

usually curative but can have a substantial impact on QOL, including the possibility of permanent

colostomy and the potential for short- and long-term bowel, bladder, and sexual dysfunction.

Given the morbidity associated with radical surgery, alternative approaches to management of

early rectal cancer have been explored, including local excision (LE) via trans-anal excision

(TAE) or TEM and trans-anal minimally invasive surgery (TAMIS). Compared to the gold

standard of radical surgery, local procedures for strictly selected early rectal cancers should lead

to identical oncological results and even better outcomes regarding morbidity, mortality, and

QOL.

Jung and associates (2018) compared the safety and efficacy between ESD and TEM for the

treatment of rectal epithelial tumors, including large adenoma, cancer, and sub-epithelial tumors

(SET). These researchers conducted a retrospective analysis of the medical records of 71

patients with rectal tumors who were treated with ESD (48 patients) or TEM (23 patients) from

January 2013 to December 2015. The patient group comprised 56 patients with epithelial

tumors and 15 patients with SET. Treatment efficacy such as en bloc resection, procedure time,

local recurrence, hospital stay, additional procedure rate, and safety between the treatment

groups were evaluated and analyzed. There were no significant differences in tumor size,

location, macroscopic appearance, and histological depth between ESD and TEM groups. For

ESD compared to TEM in rectal epithelial tumors, en bloc resection rates were 95 % versus 93.7

% and R0 resection rates were 92.5 % versus 87.5 % (p = 0.617); in rectal SET, en bloc

resection rates were 100 % versus 100 % and R0 resection rates were 87 % versus 85 % (p =



0.91). The procedure time was 71.5 ± 51.3 mins versus 105.6 ± 28.2 mins (p = 0.016) for

epithelial tumors and 32.13 ± 13.4 mins versus 80.71 ± 18.35 mins (p = 0.00) for SET,

respectively. Hospital stay was 4.3 ± 1.2 days versus 5.8 ± 1.8 days (p = 0.001) for epithelial

tumors and 4.1 ± 4.1 days versus 5.5 ± 2 days (p = 0.42) for rectal SET, respectively. There

were no significant differences between recurrence rates, additional procedure rates, and

complications in the 2 groups. The authors concluded that ESD and TEM were both safe and

effective for the treatment of rectal epithelial tumors and SET because of favorable R0 resection

rates and recurrence rates. However, the ESD group showed shorter procedure times and

hospital stays than the TEM group. Thus, ESD should be considered more preferentially than

TEM in the treatment of large rectal epithelial tumors andSET.

Leijtens and colleagues (2019) stated that TEM is used for the resection of large rectal

adenomas and well or moderately differentiated T1 carcinomas. Due to difficulty in pre-operative

staging, final pathology may reveal a carcinoma not suitable for TEM. Although completion total

mesorectal excision is considered standard of care in T2 or more invasive carcinomas, this

completion surgery is not always performed. These researchers evaluated the outcome of

patients after TEM-only, when completion surgery would be indicated. In this retrospective multi-

center, observational cohort study, outcome after TEM-only (n = 41) and completion surgery (n =

40) following TEM for a pT2-3 rectal adenocarcinoma was compared. Median follow-up was 29

months for the TEM-only group and 31 months for the completion surgery group. Local

recurrence rate was 35 % and 11 % for the TEM-only and completion surgery groups,

respectively. Distant metastasis occurred in 16 % of the patients in both groups . The 3-year OS

was 63 % in the TEM-only group and 91 % in the completion surgery group, respectively; 3-year

disease-specific survival (DSS) was 91 % versus 93 %, respectively. The authors concluded that

although local recurrence after TEM-only for pT2-3 rectal cancer was worse compared to the

recurrence that occurred after completion surgery, DSS was comparable between both groups.

The lower unadjusted OS in the TEM-only group indicated that TEM-only may be a valid

alternative in older and frail patients, especially when high morbidity of completion surgery was

taken into consideration. Nevertheless, completion surgery should always be advised when

curation is intended.

Transanal Endoscopic Microsurgery for Functional Constipation

Zhang and colleagues (2014) examined the feasibility and effectiveness of laparoscopic subtotal

colectomy and modified Duhamel procedure combined with TEM in the treatment of severe

functional constipation (SFC). The clinical data of 10 patients with SFC treated by laparoscopic

surgery combined with TEM between May 2010 and October 2012 were retrospectively

analyzed. The gastro-intestinal QOL index (GIQOLI), Wexner constipation scale and daily

frequency of defecation post-operatively during follow-up were collected. All the 10 operations



were successfully accomplished (laparoscopic subtotal colectomy combined with TEM without

abdominal incision). There was no conversion to open procedure. One case had preventive

terminal ileum stoma. The mean operative time was (256 ± 58) minutes. The mean blood loss

was (178 ± 67) ml. The mean time to first flatus was (40 ± 11) hours. There were no ureteric

injury, anastomotic leak, pelvic sepsis and other complications post-operatively. There was 1

case of insufficient small bowel obstruction that was released by conservative treatments. The

patients were discharged from the hospital in (9.0 ± 1.5) days post-operatively. The GIQOLI in 1

year post-operatively was (112 ± 10) points, which indicated good results compared to (75 ± 12)

points pre-operatively (p = 0.000). The Wexner constipation scale was 20.8 ± 2.2 pre-operatively

and decreased to 5.2 ± 1.8 at 1 year follow-up (p = 0.000). The authors concluded that

laparoscopic subtotal colectomy and modified Duhamel procedure combined with TEM provided

SFC patients a safe and feasible minimally invasive surgery. These preliminary findings need to

be validated by well-designed studies.

Transanal Endoscopic Microsurgery for Megacolon

Han and associates (2014) stated that laparoscopic-assisted colonic resection has been well-

described for multiple surgical indications and typically requires an abdominal incision for

specimen removal that is associated with most of the post-operative pain. These investigators

reported the total laparoscopic modified Duhamel operation for megacolon in combination with

TEM for transanal specimen retrieval and anastomosis to avoid the additional abdominal

extraction incision. These researchers presented 2 cases. Case 1 was a 15-year old boy who

presented with intermittent abdominal distention, pain, and constipation for 3 years' duration and

was diagnosed with Hirschsprung disease; and case 2 was a 60-year old man who presented

with repeated attacks of incomplete intestinal obstruction for 2 years' duration and was

diagnosed with adult megacolon. They were treated by the total laparoscopic modified Duhamel

operation without an abdominal extraction incision in combination with TEM. The operations

were successfully accomplished without conversion to open surgery. The patients tolerated the

procedure well, complained of minimal post-operative pain, and did not require narcotics beyond

the day of the operation. No surgical complications occurred. Discharge from the hospital

occurred on the 9th post-operative day in case 1 and the 13th post-operative day in case 2. The

authors concluded that the total laparoscopic modified Duhamel operation in combination with

TEM is a feasible and minimally invasive technique for idiopathic megacolon and adult

megacolon. These preliminary findings need to be validated by well-designed studies.

Transanal Endoscopic Microsurgery for Rectal Prolapse



Bordeianou et al (2015) stated that perineal approaches for rectal prolapse repair have low

complication rates but high recurrence rates, while abdominal approaches that include

sigmoidopexy have lower recurrence rates but higher complication rates. To optimize both

recurrence and complication rates, these researchers developed a novel procedure that uses

TEM to perform a sigmoidopexy via a perineal approach. These investigators created a rectal

prolapse model in 6 swine and 2 human cadavers using a previously published technique. The

rectum was mobilized and eviscerated transanally. After marking the planned point of sigmoid

transection, the rectum was returned to the peritoneal cavity. A TEM proctoscope was inserted

transanally alongside the rectum, and the lateral sigmoid colon walls were sutured to the sacrum.

The sigmoid colon was then transected where previously planned, and a primary sigmoid

anastomosis was performed. Total operative time, sigmoidopexy operative time, and suture

security were measured and compared to standard rectosigmoidectomy and abdominal

sigmoidopexy times. No sigmoid colon, iliac vessel, bladder, or ureteral injuries occurred. At least

2 sigmoidopexy sutures were secure on inspection in all animals and human cadavers, with

increasing success of secure suture placement as experience increased. Operative length was

similar to traditional abdominal sigmoidopexy. The authors concluded that TEM sigmoidopexy is

technically feasible. They stated that this approach has the potential to reduce the recurrence

rate associated with perineal approaches alone, but further study is needed to confirm this

hypothesis.

Transanal Endoscopic Microsurgery for Recto-Vesical Fistula

Kanehira et al (2015) stated that recto-vesical fistula is a rare complication following

prostatectomy, associated with significant symptoms such as urinary drainage from anus or

fecaluria. While several surgical procedures have been described to treat this condition, none of

them has been accepted as the universal standard. Transanal endoscopic microsurgery is a

well-established endoluminal procedure for local excision of rectal tumors. But its application to

the repair of recto-vesical fistula has been almost unknown. These researchers performed TEM

as a surgical repair for refractory recto-vesical fistula developing after radical prostatectomy in 10

patients. Under the magnified 3-D view, through the stereoscope, the fistula and the surrounding

rectal mucosa were precisely resected. The defect and the muscle layer of the rectum were

closed by hand-sew technique in 4 layers. Fistula was completely closed in 7 patients, who

eventually underwent enterostomy closure, while in the other 3 patients the fistula recurred. In

the 3 recurrent cases, the fistula was associated with wide, tough scar tissue due to previous

irradiation, high intensity focused ultrasound (HIFU), or repeated surgical repair attempts. The

authors concluded that recto-vesical fistulas associated with wide, tough scar tissue due to multi-

time attempt of surgical repair or any type of energy ablation should not be indicated for repair by



TEM. However, for simple fistulas without tough, fibrotic surroundings, TEM can be indicated as

a minimally invasive surgical option with very low morbidity, without any incision in healthy tissue

for approach. These preliminary findings need to be validated by well-designed studies.

Transanal Endoscopic Microsurgery for Anorectal Melanoma

Kong et al (2015) noted that anorectal malignant melanoma (AMM) is an uncommon malignancy

that is thought to arise from melanocytes in the mucosa around the anorectal junction. Anorectal

malignant melanoma is commonly misdiagnosed, and definitive pre-operative diagnosis is often

difficult. The prognosis of AMM is relatively poor. Although radical resection is required for

AMM, there is still no consensus at this moment on which surgical approach is preferred. These

investigators reported a rare case of AMM that was treated by TEM in combination with

radiotherapy, which resulted in complete excision of the lesion without complications. The

authors concluded that the successful treatment for this AMM using TEM emphasized the need

to broaden its application in the treatment of various rectal lesions while preserving organ

function and decreasing recurrence. This was single-case study, and its findings were

confounded by the combinational use of TEM and radiotherapy. The clinical value of TEM in the

treatment of AMM needs to be examined by well-designedstudies.

Transanal Endoscopic Microsurgery for Rectal Amyloidoma

Sharma and George (2015) noted that localized amyloidosis is characterized by amyloid protein

deposition restricted to one organ or tissue without systemic involvement. Gastro-intestinal (GI)

manifestations of localized amyloidoma are unusual, which makes amyloidoma restricted to the

rectum a very rare diagnosis requiring a high index of suspicion. These researchers presented a

rare account for rectal amyloidoma with an unusual presentation of obstructive symptoms and its

treatment using TEM, which resulted in complete excision of the lesion without hospitalization

and complications. The authors concluded that the successful treatment for this rectal

amyloidoma using TEM emphasized the need to broaden its application in the treatment of

various rectal lesions while preserving organ function and decreasing recurrence. This was

single-case study; the clinical value of TEM in the treatment of rectal amyloidoma needs to be

further investigated by well-designed studies.

Transanal Endoscopic Microsurgery for Rectal Ulcer Syndrome

Ihnat et al (2015) stated that solitary rectal ulcer syndrome (SRUS) is an uncommon chronic

disorder with a wide range of endoscopic findings, clinical presentations and characteristic

histopathological features. There is no clear consensus regarding SRUS management, because

of its poorly understood pathogenesis and frequent association with various pelvic floor



disorders. Laparoscopic resection rectopexy and TEM were used for the treatment of non-

healing SRUS. These investigators reported a case of non-healing SRUS due to obstructive

defecation syndrome based on combined pelvic floor disorders (rectocele, enterocele, internal

rectal prolapse and dolichosigma) successfully managed by a novel combined mini-invasive

approach that has never been previously reported in the literature (laparoscopic resection

rectopexy and TEM). The authors concluded that this new minimally invasive concept appeared

to be safe and feasible -- laparoscopic resection rectopexy resulted in effective correction of the

obstructive defecation syndrome, while TEM allowed comfortable access for radical resection of

a rectal ulcer. This was single-case study, and its findings were confounded by the

combinational use of TEM and laparoscopic resection rectopexy. The clinical value of TEM in

the treatment of SRUS needs to be examined by well-designed studies.

Transanal Endoscopic Microsurgery for Retro-Rectal (Pre-Sacral) Tumors

Hopper et al (2016) stated that tumors in the retro-rectal space are rare and pathologically

heterogeneous. The roles of imaging and pre-operative biopsy, non-operative management and

the indications for surgical resection are controversial. This study investigated a series of retro-

rectal tumors treated in a single institution with the aim of producing a modern improved

management algorithm. A retrospective analysis was conducted of the management of all retro-

rectal lesions identified between 1998 and 2013 from a radiology database search. Patient

demographics, presenting symptoms, imaging, biopsy, management and the results were

recorded. Descriptive statistics were used and Kaplan-Meier survival analysis was performed. A

total of 69 patients with a confirmed retro-rectal tumor were identified. The median age was 50

years (36 to 67 interquartile range) and 42 (56 %) were female; 20 (29 %) of the tumors were

malignant: 4 of 41 cystic lesions were malignant (12.9 %) versus 16 of 28 solid (or

heterogeneous) lesions (57.1 %) (p < 0.0001). Imaging demonstrated a 95 % sensitivity and 64

% specificity for differentiating benign from malignant tumors. Magnetic resonance imaging

(MRI) was significantly better at distinguishing between benign and malignant tumors than

computed tomography (CT) (94 % versus 64 %, p = 0.03). Percutaneous biopsy was performed

in 16 patients and only 27 underwent resection. There was no evidence of local recurrence

associated with biopsy. Solid lesions were associated with a non-significant decreased OS (p =

0.348). The authors concluded that the findings of this study demonstrated that MRI should be

the investigation of choice for retro-rectal lesions; biopsy of solid lesions is safe and useful for

guiding neoadjuvant and surgical therapy. Cystic lesions without suspicious radiological features

can be followed by serial imaging without resection. Transanal endoscopic microsurgery was not

mentioned as a management option.



Toh and Morgan (2016) noted that the management strategy for retro-rectal tumors is complex.

Due to their rarity, few surgeons have expertise in management. These investigators performed

a systematic review using the PubMed database. English language publications in the years

2011 to 2015 that assessed pre-operative management, surgical strategies and chemo

radiotherapy for pre-sacral tumors were included. A total of 251 abstracts were screened of

which 88 met the inclusion criteria. After review of the full text, this resulted in a final list of 42

studies eligible for review. In all, 932 patients (63.2 % female, 36.8 % male; p < 0.01) with a

retro-rectal tumor were identified. Most were benign (65.9 % versus 33.7 %, p < 0.01). Imaging

distinguished benign from malignant lesions in 88.1 % of cases; pre-operative biopsy was

superior to imaging in providing an accurate definitive diagnosis (91.3 % versus 61.4 %, p <

0.05) with negligible seeding risk. Biopsy should be performed in solid tumors. It is useful in

guiding neoadjuvant therapy for GI stromal tumors, sarcomas and desmoid type fibromatosis

and may alter the management strategy in cases of diffuse large B-cell lymphoma and

metastases. Biopsies for cystic lesions are not recommended. The gold standard in imaging is

MRI. The posterior Kraske procedure is the most common surgical approach. Overall, the

reported recurrence rate was 19.7 %. The authors concluded that this review evaluated the

management strategies for retro-rectal tumors. A pre-operative biopsy should be performed for

solid tumors; MRI is the most useful imaging modality. They stated that surgery is the mainstay

of treatment; however, there is limited information on robotic surgery, single-port surgery, TEM,

chemo-radiotherapy and reconstruction.

Ferrer-Marquez and co-workers (2017) stated that TEM was developed as a less aggressive

alternative treatment for rectal lesions (mainly adenomas and adenocarcinomas). However, its

use for other rectal lesions has become more frequent, trying to reduce the morbidity associated

with more invasive techniques. These investigators described their experience in the use of

TEM in other rectal lesions. They performed a retrospective and descriptive study including

patients operated with TEM (from June 2008 to December 2016) for the treatment of rectal

lesions different from adenomas or adenocarcinomas. Among the 138 patients treated by TEM

in the authors’ department, 10 patients were operated on for rectal lesions other than adenomas

or adenocarcinomas. Rectal lesions were 3 neuroendocrine tumors, 1 neuroendocrine tumor

metastasis, 1 rectal stenosis, 1 cloacogenic polyp, 1 endometrioma, 1 retro-rectal tumor, 1 pre

sacral abscess and 1 lesion in the recto-vaginal septum. Mean operative time was 72 minutes

and post-operative stay was 4.2 days. Only 1 patient needed a re-operation, due to rectal

bleeding. The authors concluded that TEM could be a useful tool for the treatment of rectal

lesions different from adenomas or adenocarcinomas, potentially decreasing the morbidity

associated with more aggressive surgical techniques.

Transanal Endoscopic Microsurgery for Rectal Gastro-Intestinal Stromal Tumor



Han and colleagues (2017) stated that a multi-modal treatment has been applied for patients

with rectal gastro-intestinal stromal tumor (GIST) that represents 5 % of the total localization.

Meanwhile, TEM offers a minimally invasive method for full-thickness tumor excision with

negative margins and low morbidity. These investigators reported the single most extensive

analysis of data from China to evaluate the feasibility and safety of the procedure combined with

neoadjuvant imatinib therapy to treat patients with rectal GISTs. All the clinical data were

obtained for patients who underwent the procedure in the authors hospital from February 2008 to

May 2015, and the data were retrospectively analyzed. Full-thickness excision by TEM was

performed on 25 patients with rectal GIST by using primary surgical excision, 8 of whom had

received peri-operative chemotherapy after histopathological confirmation under the care of

medical oncologists. No obvious post-operative complications were observed. The average

tumor down-sizing ratio was 14.5 %, which apparently enabled over-sized tumors to be excised

by TEM. The comparative risk did not increase during or after the procedure. These

researchers did not observe recurrence or metastasis in any of the 25 patients during the median

3-year follow-up period after the procedures. The authors concluded that peri-operative imatinib

treatment effectively allowed over-sized rectal GIST tumors to be excised by TEM, and the

procedures did not exhibit an increased risk. They stated that the TEM procedure with

neoadjuvant imatinib therapy is a feasible and safe modality for treating patients with rectal

GISTs. This was a small study (n = 25),and its findings were confounded by the peri-operative

use of imatinib. These preliminary findings need to be validated by well-designed studies.

Liu and associates (2017) reported the initial application of TEM for high-risk GIST after imatinib

mesylate (IM) therapy. A 52-year old woman suffered mild lower abdominal pain and perianal

discomfort. Physical examination found a soft mass 4 cm far away from anal verge. Rectal MRI

and trans-rectal ultrasound (TRUS) showed that there was a 1.9 ×1.6 cm submucosal mass in

the lower rectum. The incisional biopsy was performed and the pathological result reported it

was a high-risk GIST; IM was given for neoadjuvant therapy. Then TEM was adopted to resect

the residual tumor; IM was restored 4 weeks after surgery. The final pathological results

reported the margin was clear. After an 18-month follow-up, no recurrence and metastasis was

found and the patient had a satisfactory anal and urinal functions. The authors concluded that

lower rectal GIST is a rare entity that warrants special attentions of preserving anal and urinal

functions. In this case, TEM in combinations with IM neoadjuvant therapy achieved curative

resection of the tumor, satisfactory anal and urinal function and good long-term prognosis. For

the lower rectal GIST, especially when the tumor was small and responded well to IM, TEM in

combination with IM neoadjuvant therapy could be the initial attempt to achieve simultaneous

radical resection of the tumor and satisfactory anal and urinal function-preserving. Moreover,

these investigators stated that prospective, multi-center studies with a good number of patients

to validate these findings.



Furthermore, an UpToDate review on “Local treatment for gastrointestinal stromal tumors,

leiomyomas, and leiomyosarcomas of the gastrointestinal tract” (Morgan and Raut, 2017) does

not mention the use of TEM as a management tool.

Transanal Endoscopic Microsurgery for Recto-Urinary Fistula

D'Ambrosio and colleagues (2016) noted that recto-urinary fistula (RUF) is a rare complication of

pelvic surgery. Different therapeutic approaches have been reported, but a gold standard

treatment has not yet been achieved. These investigators reported the current evidence on RUF

treatment by TEM and suggested some key points for its correct management. After a search of

Medline in PubMed and Scopus databases, 7 papers were eligible for the present review. Data

were reviewed on the basis of the cases reported, patient's characteristics, surgical techniques

and results. A total of 18 cases have been reported in the literature from 1996 to 2005. The

healing success rate was 77.8 %. Fecal and urinary diversion were performed before TEM-

assisted procedure in 83 % and 94 % of cases, respectively. Recurrence occurred in 4 patients

(22 %). These researches stated that a gold standard treatment of RUF should ensure the

complete removal of scar tissue around the fistula, in order to perform a tension-free suture on

healthy margins with adequate vascularization. Pre-operative stoma improved the healing of the

fistula, reducing local inflammation and infections. The authors concluded that there inadequate

evidence to clarify which could be the best treatment; and recurrences treatment has a lower

cure rate if compared to primary lesions. They stated that more studies are needed to confirm

these findings.

In an observational study with prospective data collection, Serra-Aracil and co-workers (2018)

examined the role of transanal endoscopic operation (TEO) or TEM in recto-urethral fistulas

(RUF), which may appear after radical prostatectomy. Their treatment represents a challenge;

many therapies have been proposed, from conservative to aggressive surgical approaches.

Transanal endoscopic surgery (TEO or TEM) is a minimally invasive technique to access the site

of the RUF to perform repair. This trial was conducted between September 2006 and December

2015. All patients were diagnosed with RUF following management of prostatecancer.

Conservative treatment was administered in the form of urinary and fecal diversion with

cystotomy and terminal colostomy, to achieve total urinary and fecal exclusion. If the fistula

persisted, it was treated by TEO or TEM, with or without biological mesh interposition. If this

failed, gracilis muscle was applied as salvage therapy. A total of 10 patients were diagnosed

with RUF. In 1 patient (10 %), the fistula healed with bladder catheterization alone. In another

patient, it resolved after total urinary and fecal exclusion; 8 patients underwent repair by TEO or

TEM, 4 with biological mesh interposition; all 4 presented recurrence. In the other 4 patients

treated via TEO or TEM, 2 had early recurrence, whereas the others had healed at follow-up

visits after 4 to 6 months (2 of 8)-- a success rate of 25 %. The 6 patients who recurred were



treated with gracilis muscle interposition via a trans-perineal approach. The authors concluded

that the low rate of positive results obtained by TEO or TEM argued against its use as technique

of choice in RUF, and against the use of biological meshes.

Giant Villous Adenoma of the Rectum

Bains and colleagues (2019) stated that villous adenomas are dubiously benign lesions, which

are difficult to interpret because of their malignant potential. Distal villous adenomas present

with bleeding or mucus discharge. Giant adenomas are not amenable for endoscopic or

transanal resection. Only few isolated cases have been reported by laparoscopic resection.

These researchers presented a case of a circumferential giant villous adenoma of the rectum

managed successfully by laparoscopic ultra-low anterior resection with colo-anal anastomosis

with a review of literature in regard to their malignant potential. A 62-year old woman presented

with complaints of painless bleeding per rectum and a fleshy mass protruding from the anal

canal which on digital rectal examination appeared a large soft velvety flat mass with mucus

discharge. Colonoscopy showed circumferential irregular, friable, edematous mucosa in rectum

extending for 15 cm. Computed tomography showed a large heterogeneously enhancing

polypoid mass lesion in the rectal wall involving the entire rectum. The patient underwent

laparoscopic low anterior resection with colo-anal anastomosis and protecting loop ileostomy.

Histopathological examination of the resected specimen revealed villous adenoma of the rectum

with moderate-to-severe dysplasia. The authors concluded that villous adenomas are sessile

growths lined by dysplastic glandular epithelium, whose risk of malignancy is especially high up

to 50 % when greater than 2 cm in size. Large size, villous content, and distal location are all

associated with severe dysplasia in colorectal adenomas. Large villous rectal tumors,

particularly of circumferential type pose a great challenge for endoscopic or transanal removal.

Thus, open or laparoscopic surgery is needed for these cases. These investigators stated that

giant rectal villous polyps are usually unresectable by endoscopic methods or transanal

endoscopic microsurgery and are associated with a high rate of unsuspected cancer which

requires a formal radical oncologic resection. As per current data, the combined risk of

dysplasia/malignancy is about 83 % with 50 % risk of dysplasia and frank malignancy in 33 % of

cases of giant rectal villous adenomas of more than 8 cm in size. Laparoscopic colorectal

resection is safe and effective.

Rectal Neuroendocrine Tumor in Advanced Stages or With Metastasis

Xu and colleagues (2017) noted that rectal neuroendocrine tumor (NET) is a relatively rare

tumor. Well-differentiated NETs (G1 and G2) rarely display distant metastasis at initial diagnosis.

Currently, treatment for the primary lesions of rectal NETs with liver metastasis remains

controversial. The liver metastasis was resected in local hospital; TEM has emerged as an



effective minimally invasive surgery for local resection of lower rectal lesions. These

investigators reported the initial application of TEM to remove the rectal primary lesion in patients

with low rectal NETs (G2) with giant liver metastases. A 45-year old woman was diagnosed with

hepato-cellular carcinoma (HCC) and underwent curative resection of a giant liver lesion in a

local hospital. Nevertheless, the post-operative pathologic examination revealed that the lesion

was an NET (G2). The colonoscopy then showed a nodule of 1.4 cm in diameter, 4 cm above the

anal verge, located on the anterior wall of the rectum. The biopsy revealed that the nodule was

also an NET (G2). However, the patient did not consent to abdomino-perineal resection based

on concerns for QOL. The patient underwent curative resection of liver metastasis; and TEM

was adopted to resect the primary tumor in rectum. The patient has been disease-free for 2

years with a good QOL and presented no local recurrence in the rectum. The authors concluded

that TEM was an appropriate palliative operation for therapy of rectal NETs with distant

metastases, especially for primary rectal NETs located in low rectal. Moreover, these

researchers stated that long-term outcomes still need to be determined using a larger series of

patients. They noted that with further intensive study of targeted therapy and high-quality

combination therapy, it is possible that the prognosis and QOL of rectal NETs patients in

advanced stages or with metastasis may be improved in thefuture.

CPT Codes / HCPCS Codes / ICD-10 Codes

Information in the [brackets] below has been added for clarification purposes. Codes requiring a 7th character are represented by "+":

Code Code Description

CPT codes covered if selection criteria are met:

0184T Excision of rectal tumor, transanal endoscopic microsurgical approach (ie, TEMS),

including muscularis propria (ie, full thickness)

ICD-10 codes covered if selection criteria are met:

C20 Malignant neoplasm of rectum [low-risk] [not covered for advanced rectal cancer]

[giant villous adenoma]

C7a.026 Malignant carcinoid tumor of the rectum [rectal neuroendocrine tumor]

D01.1 - D01.2 Carcinoma in situ of rectosigmoid junction and rectum [low-risk]

D12.7 - D12.9 Benign neoplasm of rectosigmoid junction, rectum and anus and an al canal

[including giant villous adenoma]

D3A.026 Benign carcinoid tumor of the rectum [rectal neuroendocrine tumor]

ICD-10 codes not covered for indications listed in the CPB (not all inclusive):



Code Code Description

B57.32 Megacolon in Chagas' disease

C43.51 Malignant melanoma of anal skin

C49.A0 - C49.A9 Gastrointestinal stromal tumor [rectal gastro-intestinal stromal tumor]

K57.00 - K57.93 Diverticular disease of intestine

K59.31 - K59.39 Megacolon, not elsewhere classified

K59.00 - K59.09 Constipation

K62.3 Rectal prolapse

K62.4 Stenosis of anus and rectum

K62.6 Ulcer of anus and rectum

K62.89 Other specified diseases of anus and rectum [rectal amyloidoma]

N32.8 Other specified disorders of bladder

N36.0 Urethral fistula [recto-urinary fistula]

Q42.1 Congenital absence, atresia and stenosis of rectum without fistula

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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and

constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or

program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any

results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna

or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be

updated and therefore is subject to change.

Copyright © 2001-2019 Aetna Inc.



AETNA BETTER HEALTH® OF PENNSYLVANIA

Amendment to Aetna Clinical PolicyBulletin Number: 0747

Transanal Endoscopic Microsurgery

There are no amendments for Medicaid.

www.aetnabetterhealth.com/pennsylvania revised 10/10/2019

Proprietary

http://www.aetnabetterhealth.com/pennsylvania

0747 transanal endoscopic microsurgery (1)...oct 15, 2019 · aetna considers transanal endoscopic...

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