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GLOBAL VALUE DOSSIER FOR MINIMALLY INVASIVE SURGERY (MIS)

Global Value Dossier: Gastrectomy for gastric cancer 1

GLOBAL VALUE DOSSIER FOR MINIMALLY INVASIVE SURGERY (MIS)

GASTRECTOMY FOR GASTRIC CANCER

Global Value Dossier: Gastrectomy for Gastric Cancer 2

Prepared by: Jayne Smith-Palmer and Barney Hunt

Ossian Health Economics and Communications, Bäumleingasse 20, 4051 Basel, Switzerland

Phone: +41 61 271 6214

E-mail: [email protected]

Version No. 2.2

Date: April 02, 2016


Contents

1. Gastrectomy for gastric cancer ......................................................................................... 4

1.1. Overview of procedure .............................................................................................. 4

1.2. Clinical and economic outcomes with minimally invasive versus open gastrectomy for gastric cancer ..................................................................................................... 12

1.1.1. Clinical and economic evidence tables ............................................................ 19

1.3. References ............................................................................................................... 28

List of Tables

Table 1-1 Summary of meta-analyses comparing laparoscopic versus open gastrectomy for gastric cancer ................................................................................................. 20

Table 1-2 Summary of key clinical studies comparing laparoscopic versus open gastrectomy for gastric cancer ........................................................................... 21

Table 1-3 Summary of key studies comparing economic outcomes of laparoscopic versus open gastrectomy for gastric cancer .................................................................. 27

List of Figures

Figure 1-1 Surgical interventions for gastric cancer in Japan ............................................ 4

Figure 1-2 Percentage of gastrectomies carried out using laparoscopy in the UK ............ 5

Figure 1-3 Port placement for laparoscopic gastrectomy ................................................. 6

Figure 1-4 Ligation of the gastro-epiploic vein and artery ................................................. 7

Figure 1-5 Ligation of the left gastric artery ....................................................................... 8

Figure 1-6 Section of the esophagus .................................................................................. 8

Figure 1-7 Preparation of the esophago-jejununal anastomosis ....................................... 9

Figure 1-8 Length of stay with laparoscopic versus open gastrectomy for gastric cancer . .......................................................................................................................... 15

Figure 1-9 Operating time with laparoscopic versus open gastrectomy for gastric cancer .......................................................................................................................... 16

Figure 1-10 Surgical site infection with laparoscopic versus open gastrectomy for gastric cancer ............................................................................................................... 17

Figure 1-11 Operative blood loss with laparoscopic versus open gastrectomy for gastric cancer ............................................................................................................... 18

Figure 1-12 Total costs and operating costs for laparoscopic versus open gastrectomy for gastric cancer in Japan (Yasunaga et al. 201323) ................................................. 19


1. Gastrectomy for gastric cancer

1.1. Overview of procedure

Gastric cancer is the fifth most common cancer and the third most common cause of cancer death worldwide.1 Outcomes for patients with gastric cancer vary greatly across countries, with 5-year survival rates ranging from 25% in Europe to 70% in Japan.2 These differences are likely to be due to earlier diagnosis in Japan due to greater screening, whilst in Europe the disease is often diagnosed at a more advanced stage. Whilst perioperative and adjuvant chemotherapy and radiotherapy can be used to improve patient outcomes, gastrectomy is the only curative therapy available. The surgery may involve partial gastrectomy, total gastrectomy or esophagogastrectomy, depending on the location and size of the malignancy.

The first laparoscopic gastrectomy with lymphadenectomy was performed in 1991 by Prof. Seigo Kitano at Kyushu University, Japan.3 The proportion of gastrectomies performed using a laparoscopic approach is increasing, particularly in recent years. However, uptake of laparoscopic gastrectomy has been much faster in Japan and Korea than in Europe and the USA (Figure 1-1 and Figure 1-2).

Figure 1-1 Surgical interventions for gastric cancer in Japan

ESD, endoscopic submucosal dissection; LADG, laparoscopic assisted distal gastrectomy, Source: Kitano and Yang 20124


Figure 1-2 Percentage of gastrectomies carried out using laparoscopy in the UK

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Source: Mamidanna et al. 20135

Following administration of general anesthesia, the patient is placed in the reverse Trendelenburg position. A 12 mm trocar is placed in the umbilicus and pneumoperitoneum established. Four 10 mm trocars are placed in the upper part of the abdomen: two in the xypho-umbilical line and two in the mid-clavicular right and left lines (Figure 1 3). Two 5 mm trocars are placed, one each in the right and left hypochondrium.


Figure 1-3 Port placement for laparoscopic gastrectomy

1= First surgeon, 2 and 3= assistants

Source: Azagra et al. 20136

The great omentum is sectioned 2 cm below the gastro-epiploic vessels at the level of the antrum. Access to the omental cavity is then widened to the left to establish the loco-regional spread. The gastro-splenic vessels are sectioned to the left gastro-phrenic ligament. The gastro-colic ligament is cut and the right gastro-epiploic vessels are exposed and ligated from their origin on the gastro-duodenal artery and the gastro-colic vein (Figure 1-4). The artery is dissected forwards to the duodenum to the point where it arises from the hepatic artery.


Figure 1-4 Ligation of the gastro-epiploic vein and artery

Source: Azagra et al. 20136

The hepato-duodenal ligament is cut above the duodenum and the gastroduodenal artery is dissected along the posterior face of duodenum. The right gastric artery is ligated at its origin on the hepatic artery. The duodenum is then sectioned 2 cm after the pylorus. The lesser omentum is cut starting from the lower side of the liver up to the right side of the esophagus.

The hepatic artery is dissected to the celiac trunk at the top of the pancreas. The splenic artery is dissected for the first 3 cm from the celiac trunk, as is the origin of the left gastric artery. The left gastric vein is ligated at the top of the pancreas. The left gastric artery is ligated at its origin on the celiac trunk (Figure 1-5). Dissection continues along the aorta to the left and right diaphragm. The esophagus is freed from the lower mediastinum and sectioned transversely 2 cm above the cardia (Figure 1-6). The stomach is now free and can be placed into a laparoscopic sac for extraction, most commonly through a Pfannenstiel incision.


Figure 1-5 Ligation of the left gastric artery

Figure 1-6 Section of the esophagus


Following removal of the stomach, the Pfannenstiel incision is closed and the pneumoperitoneum is reestablished. The surgical team carries out an esophago-jejunostomy (Figure 1-7). Instruments are then removed, followed by the trocars. Port sites are closed and sterile dressings applied.

Figure 1-7 Preparation of the esophago-jejununal anastomosis


Guidelines on laparoscopic gastrectomy

2008 United Kingdom National Institute for Health and Care Excellence (NICE) guidance on laparoscopic gastrectomy for cancer7

For patients whose gastric cancer is diagnosed at a stage that is amenable to surgical treatment, the options include open or laparoscopic gastrectomy

Current evidence on the safety and efficacy of laparoscopic gastrectomy for cancer appears adequate to support the use of this procedure, provided that normal arrangements are in place for clinical governance, consent and audit

This procedure is technically demanding. Surgeons undertaking it should have specific training and special expertise in laparoscopic surgical techniques, and should perform their initial procedures with an experienced mentor

Patient selection and management should be carried out in the context of a multidisciplinary team with established experience in the treatment of gastric cancer

2014 American College of Radiology (ACR) Appropriateness Criteria® resectable stomach cancer8

Surgical resection is an essential component of the management of gastric cancer and may involve various approaches including endoscopic mucosal resection for early stage (Tis, T1a) disease and minimally invasive laparoscopic resection or open gastrectomy for more advanced disease

Minimally invasive approaches are becoming increasingly popular due to technological advances and the publication of data from randomized studies, which demonstrate equivalent outcomes with laparoscopic procedures compared with open techniques

Commonly, a total gastrectomy is utilized for proximal or middle third lesions, and a partial gastrectomy is recommended for lesions in the distal third of the stomach

The goal of resection is to obtain a negative margin (R0) resection since a microscopically positive (R1) resection is associated with a worse prognosis, and typically a wide resection margin (4 cm to 6 cm) around the primary gastric cancer is desired for potentially curative surgery


2012 Laparoscopic gastrectomies for cancer: The ACOI-IHTSC national guidelines9

Laparoscopic gastrectomy may be considered as a safe procedure with better short-term and comparable long-term results compared to open gastrectomy

There is a general agreement that a laparoscopic approach to the treatment of gastric cancer should be chosen only by surgeons already highly skilled in gastric surgery and other advanced laparoscopic interventions

The first procedures should be carried out during a tutoring program

Diagnostic laparoscopy is strongly recommended as the first step of laparoscopic as well as laparotomic gastrectomies


1.2. Clinical and economic outcomes with minimally invasive versus open gastrectomy for gastric cancer

Key findings

Clinical outcomes

Length of stay: In the majority of studies, length of stay was significantly shorter following laparoscopic gastrectomy than open gastrectomy23,25,26,30,31,32,34,35,37,39 (

Figure 1-8). Length of stay was also consistently significantly shorter with laparoscopic gastrectomy in meta-analyses19,20,21

Operating time: Operating time was consistently longer for laparoscopic gastrectomy than for open gastrectomy28,29,31,32,34,35,36,37,38,39(Figure 1-9), with this difference achieving significance in several individual studies28,29,34,35 and meta-analyses19,20,21

Surgical site infection: Overall rates of surgical site infection were low for both open and laparoscopic gastrectomy (Figure 1-10), statistical significance was infrequently reported due to low patient numbers22,23,25,34,37

Blood loss: There was consistently less blood loss with laparoscopic versus open gastrectomy22,25,26,31,32,34,35,37,38,39 (Figure 1-11), with several studies showing significantly less blood loss than with open surgery22,25,26,31,32,34,37,38

Transfusion: The proportion of patients requiring blood transfusion was lower with laparoscopic gastrectomy than with open gastrectomy19,25,29,30,34; in two individual studies and one meta-analysis this proportion was significantly lower19,25,34

Overall survival: In most studies reporting long-term survival, there was no significant difference in overall survival between laparoscopic and open gastrectomy for gastric cancer;24,31,32,33 however, one study reported a significant benefit in favor of laparoscopic gastrectomy25

Disease-free survival: Two studies reported no significant difference between laparoscopic and open gastrectomy for gastric cancer in terms of disease-free survival;32,33 however, one study reported a significant benefit in favor of laparoscopic gastrectomy25

Post-operative complications: Five studies reported no significant difference between open and laparoscopic gastrectomy in terms of the overall incidence of post-operative complications22,25,28,29,35 but four studies reported significantly lower rates of overall post-operative complications with laparoscopic gastrectomy than with open gastrectomy26,31,34,37

Oral intake: In the majority of studies time to oral food intake was significantly shorter with laparoscopic gastrectomy compared with open gastrectomy30,31,32,35,37

Pain medication: Pain medication requirements in the initial post-operative period were significantly lower for patients who underwent laparoscopic gastrectomy compared with open gastrectomy28,35

Economic outcomes

Total hospital costs: Cost data from European and North American studies are lacking but two studies from Asia show laparoscopic gastrectomy to be associated


with significantly higher costs than open gastrectomy23,39

o Japan: In one Japanese study total hospital costs were significantly higher for laparoscopic gastrectomy than for open gastrectomy (Figure 1-12)23

o China: In one Chinese study total hospital costs were significantly higher for laparoscopic gastrectomy than for open gastrectomy39

Operating costs:

o Japan: In Japan total operating costs were higher for laparoscopic gastrectomy than for open gastrectomy (Figure 1-12)23

Savings due to clinical benefits: In a Japanese study the higher operating costs associated with laparoscopic gastrectomy were partially offset by savings due to a significantly shorter length of stay23

Other findings

Surgical trauma: Post-operative levels of inflammatory markers including C-reactive protein and IL-6 were significantly lower after laparoscopic gastrectomy than after open gastrectomy10,38 suggesting that levels of surgical trauma are significantly lower with laparoscopic gastrectomy.

Learning curve: A learning curve exists with laparoscopic gastrectomy, with operating time and incidence of complications decreasing with surgeon experience.28,29

Incision size: Mean incisions length was >10 cm longer with open versus laparoscopic gastrectomy.31,39

Obesity: Conflicting evidence exists on the impact of obesity on outcomes, two studies report that it does not significantly influence outcomes including blood loss, post-operative complications and length of stay in patients undergoing laparoscopic gastrectomy for gastric cancer11,12 but another meta-analysis reported significantly longer operating times, blood loss and complications in obese patients undergoing laparoscopic gastrectomy.13

Time to ambulation: One study showed that the time to ambulation was significantly shorter with laparoscopic gastrectomy than for open gastrectomy.37

Impact of co-morbidities: In patients undergoing laparoscopically-assisted gastrectomy for gastric cancer, the presence of heart disease and hepatic disease have been shown to be independent risk factors for post-operative complications.14

Risk for readmission: Major post-operative complications are a significant risk factor for 30-day readmission in patients undergoing laparoscopic gastrectomy, thereby compounding the already substantial direct medical costs for major post-operative complications,15 which some studies have shown to occur more frequently with open than with laparoscopic gastrectomy.

Age: Advanced age (≥75 years) has been found to be a risk factor for post-operative complications, but age was not significantly related to the severity of post-operative complications.16

Hospital volume: In Japan, hospital volume was not related to post-operative complications or in-hospital mortality; however, higher hospital volume was significantly related to a shorter length of stay and lower medical costs for patients undergoing laparoscopic gastrectomy for gastric cancer.17


Laparoscopically-assisted versus totally laparoscopic gastrectomy: In a Japanese study total laparoscopic gastrectomy was associated with significantly less blood loss and significantly shorter length of stay than laparoscopically-assisted gastrectomy (where the stomach is exteriorized for anastomosis and extraction) but total hospitalization costs were not significantly different.18


Figure 1-8 Length of stay with laparoscopic versus open gastrectomy for gastric cancer

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Figure 1-9 Operating time with laparoscopic versus open gastrectomy for gastric cancer

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Figure 1-10 Surgical site infection with laparoscopic versus open gastrectomy for gastric cancer

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Figure 1-11 Operative blood loss with laparoscopic versus open gastrectomy for gastric cancer

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Figure 1-12 Total costs and operating costs for laparoscopic versus open gastrectomy for gastric cancer in Japan (Yasunaga et al. 201323)

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1.1.1. Clinical and economic evidence tables

A summary of clinical evidence on laparoscopic versus open gastrectomy for gastric cancer from published meta-analyses and published studies is shown in Table 1-1 and Table 1-2, respectively. A summary of economic evidence from published cost studies is shown in Table 1-3.

In the following tables outcomes where p<0.05 are underlined.

Global Value Dossier: Gastrectomy for Gastric Cancer

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Table 1-1 Summary of meta-analyses comparing laparoscopic versus open gastrectomy for gastric cancer Authors Details Procedures Outcome OR (95% CI) P value

Chen et al. 201419 1 RCT and 13 observational studies, N=1,532 patients (n=721 laparoscopic, n=811 open)

Open versus totally laparoscopic gastrectomy for gastric cancer

Peri-operative Operating time, minutes Blood loss, mL Transfusion Retrieved lymph nodes Post-operative Time to ambulation, days Time to oral intake, days LoS, days Overall complications Medical complications Surgical complications Mortality

58 (38, 78)a −168 (−209, −126)a 0.49 (0.21, 1.11)b −0.48 (−2.21, 1.26)a −0.91 (−1.65, −0.16)a −2.39 (−3.34, −1.45)a −3.8 (−4.9, −2.6)a 0.71 (0.58, 0.86)b 0.57 (0.38, 0.86)b 0.75 (0.57, 0.98)b 0.65 (0.24, 1.76)b

<0.001 <0.001 0.09 0.59 0.02 <0.001 <0.001 <0.001 0.008 0.03 0.40

Martinez-Ramos et al. 201120

7 studies, N=452 patients (n=278 open, n=171 laparoscopic)

Open versus partial and total laparoscopic gastrectomy for gastric cancer

Peri-operative Operating time, minutes Blood loss, mL Post-operative LoS, days Cancer-related mortality risk

45 (20, 69)a −123 (−208, −37)a −6.2 (−9.5, −2.9)a 0.53 (0.23, 1.22)

<0.001 <0.001 <0.001 0.191

Xiong et al. 201321 15 non-randomized studies, N=2,022 patients (n=1,211 open, n=811 laparoscopic)

Open versus laparoscopic total gastrectomy for gastric cancer

Peri-operative Operating time, minutes Blood loss, mL Post-operative Time to oral intake, days LoS, days Overall complications Abdominal abscess Wound problems

48 (31, 63)a −201 (−297, 106)a

−1.30 (−1.84, −0.75) −3.55 (−5.13, −1.96)a 0.73 (0.57, 0.92) 0.53 (0.28, 1.03) 0.39 (0.21, 0.72)

<0.00001 <0.0001 <0.00001 <0.0001 0.009 0.06 0.002

CI, confidence interval; LoS, length of stay; OR, odds ratio; RCT, randomized controlled trial aWeighted mean difference, negative values favor laparoscopic approach bRR, values below 1.00 favor laparoscopic approach


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Table 1-2 Summary of key clinical studies comparing laparoscopic versus open gastrectomy for gastric cancer Study Setting Study details Procedure (year

performed) Summary of clinical findings Endpoint Open MIS P value

Kim et al. 201022

South Korea KLASS prospective RCT, n=161 open, n=179 laparoscopically-assisted

Open versus laparoscopically-assisted distal gastrectomy for adenocarcinoma (2006–2007)

Peri-operative Mean (SD) blood loss, mL Post-operative Wound infection, % Total complications, %

200 (166) 3.4 15.1

109 (133) 0.6 11.6

<0.001 NR 0.137

Yasunaga et al. 201323

Japan Retrospective national database analysis, n=5,451 open, n=3,937 laparoscopic (propensity matched n=2,473 pairs)

Open versus laparoscopic distal gastrectomy for stage I or II gastric cancer (2010)

Peri-operative Median (range) duration of anesthesia, minutes Median (range) LoS, days Post-operative In hospital mortality, % SSI, % 30-day re-admission, %

262 (213, 313) 15 (12, 20) 0.28 1.7 3.2

345 (289, 415) 13 (10, 17) 0.36 2.0 3.2

<0.001 <0.001 0.803 0.599 0.936

Kim et al. 201424

South Korea Retrospective case-control study, n=1,499 open, n=1,477 laparoscopic (using data from the KLASS-01 RCT) (matched results presented)

Open versus laparoscopic gastrectomy for gastric cancer (1998–2005)

Peri-operative Mortality, % Post-operative All complications, % Post-discharge 5 year overall survival, % Stage IA Stage IB Stage IIA Stage IIB Stage IIIA Stage IIIIB Stage IIIC

0.3 15.1 94.0 96.9 88.4 80.3 70.0 68.8 40.0

0.5 12.5 95.6 92.7 85.5 80.0 61.9 47.8 33.3

1.0 0.184 NR NR NR NR NR NR NR

Lin et al. 201525

China Retrospective case control study, n=1,539 open, n=2,041 laparoscopic

Open versus laparoscopic gastrectomy for gastric cancer (2005–2013)

Peri-operative Mean (SD) operating time, minutes Mean (SD) blood loss, mL Transfusion, % Post-operative Mean (SD) time to

227 (70) 199 (210) 1.6 4.7 (1.2)

190 (57) 75 (111) 0.7 4.8 (1.1)

0.399 <0.00001 0.009 0.649


22


performed) Summary of clinical findings Endpoint Open MIS P value resumption of diet, days Mean (SD) LoS, days Total complications, % Local complications, % Intra-abdominal abscess, % Wound infection, % Post-operative mortality, % Post-discharge 3-year disease-free survival, % 3-year overall survival, %

15.1 (8.3) 14.4 11.2 1.8 1.9 0.2 61.4 62.6

13.8 (6.8) 13.6 10.7 1.7 1.6 0.3 68.7 71.2

0.013 0.526 0.626 NR NR 0.740 0.001 <0.0001

Oh et al. 201426

South Korea Retrospective single center study in elderly patients, n=1,112 open, n=1,013 MIS (including n=71 robotic and n=942 laparoscopic)

Open versus minimally invasive radical gastrectomy for primary early gastric cancer (2003–2012)

Post-operative LoS, days Estimated blood loss, mL Any complication, % Local complication, % Systemic complication, % Any complication, distal gastrectomy, % Any complication, pylorus-preserving gastrectomy, % Any complication, total gastrectomy, % Any complication, proximal gastrectomy, %

11.3 142 24.4 18.7 8.2 22.3 15.9 31.5 36.5

8.7 75 17.5 14.0 4.5 16.6 17.7 47.4 19.4

<0.001 <0.001 <0.001 0.004 0.001 0.004 0.736 0.167 0.062

Lee et al. 201427

South Korea Retrospective single center analysis, n=816 open, n=1,058 laparoscopic

Open versus laparoscopic distal or total gastrectomy for gastric cancer (2003–2009)

Post-discharge Any recurrence, % Locoregional recurrence, % Hematogenous recurrence, % Distant lymph node metastasis, % Peritoneal recurrence, %

21.8 1.3 7.6 5.5 13.8

4.7 0.7 2.2 1.2 2.2

<0.001 1.131 <0.001 <0.01 <0.001


23



Song et al. 201528

South Korea Retrospective single center (single surgeon) analysis, n=134 open, n=74 laparoscopic

Open versus laparoscopic total gastrectomy for gastric cancer (2009–2013)

Peri-operative Mean (SD) operating time, minutes Mean (SD) blood loss, g Mean (SD) Number of lymph nodes retrieved Post-operative Mean (SD) time to diet, days Total complications, % Mean (SD) LoS, days Mean (SD) pain killers used, Day 7

176 (43) 130 (127) 45 (18) 6.0 (1.9) 11.9 9.0 (3.1) 7.7 (5.8)

218 (63) 81 (60) 40 (12) 5.7 (2.0) 13.5 8.3 (3.4) 4.7 (4.0)

<0.001 <0.001 0.020 0.252 0.660 0.097 <0.001

Kang et al. 201029

South Korea Retrospective single center (single surgeon) analysis, n=90 open, n=90 laparoscopically-assisted

Open versus laparoscopically-assisted distal gastrectomy with gastric cancer (2004–2007)

Peri-operative Mean (SD) operating time, minutes Transfusion, % Mean (SD) number of lymph nodes dissected Complications, %

168 (36) 10 38 (16) 12.2

184 (43) 4.4 38 (21) 16.7

<0.01 ns ns ns

Ramagem et al. 201530

Brazil Retrospective single center analysis, n=64 open, n=47 laparoscopic

Open versus laparoscopic total gastrectomy for gastric adenocarcinoma (2009–2013)

Peri-operative Blood transfusion, % Mean (SD) operating time, minutes Post-operative Mean (SD) time to oral diet, days Mean (SD), LoS, days

27 256 (55) 3.9 (1.5) 7.4 (4.0)

14.9 216 (23) 2.3 (1.1) 1.6 (0.7)

0.14 0.001 0.001 0.002

Li et al. 201431

China Retrospective single center analysis in elderly patients (≥70 years), n=54 open, n=54 laparoscopic

Open versus laparoscopic radical gastrectomy for elderly patients with gastric cancer (2008–2009)

Peri-operative Mean (SD) operating time, minutes Mean (SD) blood loss, mL Mean (SD) lymph nodes resected, n Mean (SD) incision length,

173 (29) 141 (44) 26.7 (4.6) 17.8 (1.0)

179 (23) 103 (34) 27.8 (3.9) 5.18 (0.7)

0.201 0.000 0.167 0.000


24


performed) Summary of clinical findings Endpoint Open MIS P value cm Post-operative Mean (SD) time to normal diet, days Mean (SD) LoS, days Total complications, % Post-discharge 3 year survival, %

3.8 (0.8) 9.4 (1.5) 29.6 57.4

3.0 (0.4) 7.0 (1.3) 14.8 55.6

0.000 0.000 0.040 0.846

Huscher et al. 200532

Italy Prospective single center randomized trial, n=29 open, n=30 laparoscopic

Open versus laparoscopic subtotal gastrectomy for distal gastric cancer (1992–1996)

Peri-operative Mean (SE) operating time, minutes Mean (SE) blood loss, mL Post-operative Mortality, % Morbidity, % Mean (SE) time to oral food intake, days Mean (SE) LoS, days Post-discharge 5-year overall survival, % 5 year disease-free survival, %

168 (29) 391 (136) 6.7 27.6 7.4 (2.0) 14.5 (4.6) 55.7 54.8

196 (21) 229 (144) 3.3 26.7 5.1 (0.5) 10.3 (3.6) 58.9 57.3

NR <0.001 ns ns <0.001 <0.001 ns ns

Sica et al. 201133

Italy Prospective non-randomized trial, n=25 open, n=22 laparoscopic

Open versus laparoscopic gastrectomy for adenocarcinoma of the stomach (2000–2004)

Post-discharge 5-year mortality rate, % Cancer-related 5-year mortality rate, % Median (range) survival, months Median (range) disease-free survival, months

56 52 38 (11, 60) 26 (10, 60)

54.5 50 39 (12, 60) 28 (12, 60)

1 1 0.7 0.6

Wang et al. 201334

China Retrospective case control study, n=54 open, n=54 laparoscopically-

Open versus laparoscopically-assisted distal gastrectomy for gastric

Peri-operative Mean (SD) operating time, minutes Mean (SD) blood loss, mL

200 (41) 258 (151)

259 (46) 160 (86)

<0.01 <0.01


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assisted cancer (2004−2007) Blood transfusion, % Mean (SD) number of lymph nodes retrieved Post-operative Mean (SD) LoS Overall complications, % Wound infection, % Re-operation, %

32 28 (10) 11.1 (4.1) 24.1 3.7 5.6

1.9 28 (8) 9.5 (2.7) 13.0 0 0

<0.01 0.94 0.02 0.03 NR 0.24

Kwon et al. 201435

South Korea Retrospective single center study, n=58 open, n=18 minimally invasive (including n=10 laparoscopic and n=8 robotic)

Open versus minimally invasive surgery for remnant gastric cancer (2005–2012)

Peri-operative Mean (SD) operating time, minutes Mean (SD) estimated blood loss, mL Post-operative Median (range) analgesic injections, n Median (range) time to soft diet, days Median (range) LoS, days Overall complications, % Severe complications, %

203 (52) 193 (228) 9 (0, 38) 6 (4, 15) 9 (6, 28) 45 15.5

266 (77) 182 (189) 4 (0, 15) 4 (4, 23) 6 (5, 44) 33 16.7

0.004 0.855 0.0004 0.001 <0.001 0.388 >0.999

Shim et al. 201336

South Korea Retrospective single center matched cohort study, n=35 open, n=35 laparoscopic

Open versus laparoscopic total gastrectomy for gastric adenocarcinoma (2009–2011)

Peri-operative Mean operating time, minutes Post-operative Early complications, %

213 23

230 20

>0.05 NR

Qiu et al. 201437

China Retrospective analysis in elderly (≥70 years) patients, n=34 open, n=30 laparoscopically-assisted

Open versus laparoscopically-assisted radical gastrectomy for stage IIA to IIIB gastric cancer in elderly (≥70 years) patients (2012–2013)

Peri-operative Mean (SD) operating time, minutes Mean (SD) blood loss, mL Mean (SD) number of lymph nodes retrieved Post-operative Mean (SD) time to oral

236 (45) 227 (147) 28 (12) 5.5 (1.0)

260 (54) 120 (53) 30 (12) 4.5 (0.8)

0.068 <0.01 0.484 <0.01


26


performed) Summary of clinical findings Endpoint Open MIS P value intake, days Mean (SD) time to ambulation, days Mean (SD) LoS, days Total post-operative complications, % SSI, %

4.1 (1.0) 16.9 (4.1) 47 0

1.2 (0.4) 13.0 (4.2) 23 3.3

<0.01 <0.01 0.048 NR

Kumagai et al. 201438

Japan Prospective single center study, n=20 open, n=19 laparoscopically-assisted

Open versus laparoscopically-assisted distal gastrectomy for gastric cancer (2012)

Peri-operative Median (range) operating time, minutes Median (range) blood loss, mL Peri-operative complication, %

179 (95, 281) 230 (345, 740) 10

202 (137, 378) 15 (5.0, 145) 5.6

0.052 <0.01 0.58

Shu et al. 201339

China Single center study, n=21 open, n=15 laparoscopic

Open versus laparoscopic resection for gastric gastrointestinal stromal tumors (2010–2012)

Peri-operative Mean (SD) operating time, minutes Mean (SD) incision length, cm Mean (SD) blood loss, mL Post-operative Mean (SD) LoS

139 (62) 16.9 (3.8) 154 (99) 11.3 (3.7)

148 (59) 7.8 (2.3) 150 (99) 7.6 (2.5)

0.342 <0.05 0.721 0.026

LoS, length of stay; MIS, minimally invasive surgery; NR, not reported; ns, not significant; SD, standard deviation; SSI, surgical site infection


27

Table 1-3 Summary of key studies comparing economic outcomes of laparoscopic versus open gastrectomy for gastric cancer Study Setting Study details Procedures Currency

(Cost year) Cost Outcome Open MIS P value

Yasunaga et al. 201323

Japan Retrospective national database analysis, n=5,451 open, n=3,937 laparoscopic (propensity matched n=2,473 pairs)

Open versus laparoscopic distal gastrectomy for stage I or II gastric cancer (2010)

USD (2010) Median (range) total cost Median operation costs

21,024 (18,917, 25,139) 10,886

21,510 (19,530, 24,379) 12,303

0.002 NR

Shu et al. 201339

China Single center study, n=21 open, n=15 laparoscopic

Open versus laparoscopic resection for gastric gastrointestinal stromal tumors (2010–2012)

RMB (year not stated)

Mean (SD) total hospitalization cost

23,761 (5,362) 28,239 (5,521) <0.05

MIS; minimally invasive surgery; NR, not reported, SD, standard deviation



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