Introduction

Stapler-Assisted Total Laryngectomy: Lessons Learned

Nancy Jiang, MD; Edward J. Damrose, MD, FACS Department of Otolaryngology-Head and Neck Surgery

Stanford University School of Medicine, Stanford, California.

Abstract

SATL is easy to teach with reproducible results regardless of surgeon experience, and has similar rates of PCF compared to TLSC with appropriate technical modifications.

Conclusions

Discussion

References

1. Sessions RB, Shemen LJ, Reuter VE. Staple closure of thegullet after laryngectomy: an experimental study. Otolaryngol Head Neck Surg 1986;95:491–499. 2. Jones, D.W., Garrett, K.A.. Anastomotic technique-Does it make a difference? Seminars in Colon and Rectal Surgery 2014;25(2.) 3. Lukyianchenko AG, Knowles JEA. Suturing of a laryngeal defect in laryngectomy. Vestn Otorhinolaringol 1971;33:29–30. 4. Aires FT, Dedivitis RA, Castro MA, Bernardo WM, Cernea CR, Brandao LG. Efficacy of stapler pharyngeal closure after total laryngectomy: a systematic review. Head Neck 2013; 36:739–7425. 5. Miles B, Larrison D, Myers L. Comparison of complication rates associated with stapling and traditional suture closure after total laryngectomy for advanced cancer. Ear, Nose & Throat Journal 2013;92(8):302-399. 6. Bedrin L, Ginsburg G, Horowitz Z, Talmi YP. 25-year experience of using a linear stapler in laryngectomy. Head Neck 2005;27(12):1073-9. 7. Sofferman RA, Voronetsky I. Use of the linear stapler for pharyngoesophageal closure after total laryngectomy. Laryngoscope 2000;110:1406–1409. 8. Goncalves AJ, de Souza JAL, Menezes MB, Kavabata NK, Suehara AB, Lehn CN. Pharyngocutaneous fistulae following total laryngectomy comparison between manual and mechanical sutures. Eur Arch Otorhinolaryngol 2009;266:1793–1798. 9. RA Dedivitis Aires FT, Pfuetzenreiter Jr EG, Castro MAF, Guimaraes AV. Stapler suture of the pharynx after total laryngectomy. Acta Otorhinolaryngol Ital 2014; 34(2): 94–98.

Results Methods

Importance: Stapler-Assisted Total Laryngectomy (SATL) affords simultaneous laryngectomy with concomitant pharyngeal closure, decreasing operative time and simplifying pharyngeal repair. The technique is simple to perform, easy to teach, readily standardizes the method of closure between patients to allow for outcome comparisons, and decreases outcome variability secondary to technical proficiency between more or less experienced surgeons. There is relatively little information regarding the technical nuances of SATL. The few available studies are conflicted regarding the rate of pharyngocutaneous fistula (PCF), compared to total laryngectomy with suture closure (TLSC). SATL has been associated with PCF rates higher than traditional TLSC, but in our experience, there is a learning curve associated with the procedure, and modifications to the classic technique can allow for fistula rates comparable to traditional TLSC. Objective: To describe our experience with SATL versus TLSC. Design: Retrospective case series. Setting: Tertiary referral center. Participants: 52 patients who underwent total laryngectomy between 2004 and 2014. Intervention(s): 30 patients underwent TLSC; 22 patients underwent SATL. Main Outcome(s) and Measures: The overall rate of PCF was compared between groups. The rate of PCF was also compared between 1) our first 2 years of experience SATL (between 2010 and 2011) and 2) the following 2.5 years (between 2012 and 2014) of experience with SATL, after improvements were made in the technique. These improvements included the use of a vascular staple load, electrodessication of the exposed mucosa, and oversewing of the suture line. Results: There was no significant difference in patient demographics, medical comorbidities, or history of radiation and chemotherapy between groups. The PCF rates for TLSC and SATL were 6.7% and 27.3%, respectively (p = 0.058). The PCF rate for the staple group between 2010 and 2011 was 38.5%, compared to 11.1% for the staple group between 2012 and 2014. There was a significant difference in the rate of PCF between the suture group and the staple group between 2010 and 2011 (p = 0.019). Conclusions and Relevance: With training and technical refinements, SATL affords significant advantages to TLSC, with comparable PCF rates.

Closure of the pharyngeal defect after total laryngectomy has been traditionally performed with tedious manual suturing techniques that invert the mucosal edge. This concept of mucosal edge inversion is thought to decrease the rate of pharyngocutaneous fistula (PCF), which is the most common complication after total laryngectomy.1 However, with the development of anastomotic staplers used in gastrointestinal surgery, where the mucosal edge is everted on stapling, this need for inversion of the mucosa for successful closure has been challenged. Stapling techniques have been widely adopted by general surgeons in bowel anastomosis and the rate of anastomotic leak has not been shown to be worse than hand suturing. Benefits of using a stapling device have been touted to include less tissue manipulation with less tissue edema, uniformity in the placement of the staplers, and shortened operative times.2 Use of stapling devices to successfully close the pharyngeal defect after total laryngectomy was first described in 1971.3 However, unlike lower gastrointestinal surgery, stapler assisted total laryngectomy (SATL) has not been widely adopted. There are few studies that compare SATL directly to total laryngectomy with suture closure (TLSC). A recent systematic review of SATL versus TLSC only found 4 studies that compared the two different techniques, with a metaanalysis that suggested SATL had a lower risk of PCF than TLSC, although one of the 4 studies showed a higher rate of PCF in SATL.4 A recent study by Miles et al that was published after this metaanalysis showed the PCF rate for SATL to be 31.3% compared to 11.5% for the TLSC group, although this was not a statistically significant difference.5 These conflicting data regarding the rate of PCF may be one of the main reasons for the hesitation in wide adoption of SATL. In our experience, the rate of PCF can be improved upon by modifying the classic technique described in the literature, which uses a linear stapler with a single stapling application.6 In this study, we describe our improved rates of PCF after modifications were made to the SATL procedure, including use of a vascular staple load, electrodessication of the exposed everted mucosa along the staple line, and oversewing of the suture line.

A retrospective chart review was performed of all patients who underwent total laryngectomy between 2004 and 2014. All patients underwent primary closure of the neopharynx. Patients were excluded from the study if pharyngeal reconstruction was needed with a locoregional flap or free tissue transfer. The patients were divided into 3 groups: 1) TLSC technique, 2) classic SATL technique, and 3) modified SATL technique. Data obtained included patient demographics, factors that can contribute to wound healing (i.e. diabetes, hypothyroidism), primary tumor staging, history of radiation and/or chemotherapy, occurrence of PCF, intraoperative complications due to the technique employed, postoperative NPO length, and length of hospital stay. Fisher’s exact test and independent t-tests were used to statistically compare the data between groups. Surgical Procedures All patients underwent direct laryngoscopy to ensure that the primary tumor was amenable to primary closure of the neopharynx. The TLSC group underwent closure of the neopharynx with a running Connell suture using 3-0 vicryl. In both the classic and modified SATL groups, two endosutures were placed through the epiglottis during direct laryngoscopy prior to performing the total laryngectomy. These sutures were then passed into the trachea and later grasped to help invert the epiglottis prior to stapling. The patients in the classic SATL technique group underwent closure of the neopharynx using a TX60B linear stapler (Ethicon Endo-surgery, Cincinnati, OH, USA). One load was used and no oversewing was performed. This technique was performed between 2010 and 2011 by the senior author. The patients in the modified SATL technique group underwent closure in the following fashion: 1) Closure of the neopharynx was performed with a linear stapler-cutter device with vascular reload (EndoGIA, US Surgical, Norwalk, CT, USA). 2) The exposed mucosa over the everted edge of the closure was then electrodesiccated using a bovie electrocautery device (Figure 1). 3) The closure was reinforced by oversewing the suture line with interrupted 3-0 vicryl sutures (Figure 2). This modified technique was performed between 2012 and 2014 by the senior author.

A total of 52 patients met inclusion criteria for the study. Thirty patients underwent TLSC and 22 patients underwent SATL. Among the 22 SATL patients, 13 underwent the classic stapler technique and 9 underwent the modified stapler technique. The average age was 67 years and 88% of patients were male. Forty-four patients had squamous cell carcinoma, 2 patients had chrondrosarcoma, 1 patient had adenoid cystic carcinoma, 1 patient had a giant cell tumor, 1 patient had spindle cell carcinoma, 1 patient had chondronecrosis of the larynx, and 2 patients had intractable aspiration. Of the patients who had squamous cell carcinoma, 77% (34 patients) had either T3 or T4 disease. There was no significant difference in patient demographics, medical comorbidities, or history of radiation and chemotherapy between groups. These findings are summarized in Table 1. The average length of NPO time post-operatively could not be determined because this information was not consistently recorded in the patient records. The average length of hospital stay for all patients was 8 days. A primary tracheoesophageal puncture (TEP) was performed in 32% of the SATL patients (7 patients) and 21% of the TLSC patients (7 patients). Intraoperative complications for the TLSC group include 2 failed attempts at TEP placement. Intraoperative complications for the SATL group include the following: 3 cases where leakage was detected on methylene blue leak test of the staple line that was then oversewn, 2 cases where the epiglottis was unsuccessfully inverted before stapling, 1 case where the epiglottis was caught in the staple line, and 1 case were the nasogastric tube was caught in the staple line. The PCF rate for the SATL group, including both the classic and modified technique, was 27.3%. The PCF rate for the TLSC group was 6.7%. This difference was close to significant, with a p-value of 0.058. The PCF rate for the classic SATL group (performed between 2010 and 2011) was 38.5%, compared to 11.1% for the modified SATL group (performed between 2012 and 2014). There was a significant difference in the rate of PCF between the TLSC group and the classic SATL group (p = 0.019), but no significant difference between the TLSC group and the modified SATL group (p = 1.000). These findings are summarized in Table 2.

SATL is a surgical technique that has many benefits over TLSC. It is a technique that is easy to teach. The results are easily reproducible because the same pharyngeal closure is obtained every time it is performed, regardless of the surgeon. It also a technique that is less time consuming than TLSC.7 However, the concern is whether the rate of PCF in SATL is comparable to TLSC. The literature has demonstrated conflicting results. The largest study of SATL included 1387 patients and the PCF rate was 12%, which is comparable to the TLSC technique. 6 Goncalves et al, in their prospective study, had a PCF rate of 6.7% with the stapler, compared to 36.7% with hand suturing.8 However, other studies have shown that the rate of PCF is actually higher in SATL.5,9 This difference may be in part due to the learning curve that is associated with SATL. Considerations include the type of stapling device used, treatment of the everted mucosal edge, and whether or not a second layer of closure is performed. In our experience, after modifications were made to the SATL technique, the rate of PCF decreased from 38.5% to 11.1%. These modifications include the use of a vascular staple load, electrodessication of the everted mucosal edge along the staple line, and oversewing the staple line. The vascular staple load is different than the tissue staple load in that there are 3 rows of staples rather than 2 rows. Prior to switching to the vascular load, we had 3 cases (23%) were there was leakage at the staple line on leak test with methylene blue stained saline. There have been no cases of leakage at the staple line since we switched to using the vascular load. After the neopharyngeal closure is created with the stapler, the everted mucosa at the edge of the stapler line was ablated using electrocautery. The goal in this technique is to try to promote intraluminal reepithelialization. Sessions, in his canine study of SATL, suggested that SATL is inferior to manual suturing with inversion of the mucosa because histological evaluation of the stapler line showed failure of intraluminal reepithelialization due to the everted mucosa.1 By performing electrodessication, we are attempting to improve upon the problem demonstrated by Sessions. Oversewing of the suture line was also initiated to help decrease the rate of PCF. This is quick, easy to perform, and helps to reinforce the pharyngeal closure. We saw no downside to adding this step in SATL. In combining these modifications, we noticed a significant decrease in our rate of PCF, with results comparable to TLSC. If the same or lower rates than PCF are obtainable with the SATL technique compared to the TLSC technique, then SATL could be considered to be more the more advantageous procedure. Our study suggests that comparable rates of PCF can be achieved with refinements in the technique of SATL, all of which add little surgical time or technical difficulty to the procedure.

Patient Factors SATL (22 patients) TLSC (33 patients) P value

Age (years) 63 69 0.128

Gender 18 male 28 male 0.382

Neck Dissection 16 22 1.000

Hypothyroidism 5 9 0.753

Diabetes 3 6 0.717

Smoking 16 27 0.144

Drinking 15 22 0.762

Radiation 10 14 1.000

Chemotherapy 0 3 0.253

PCF Rate 6 2 0.058

Table 1. Patient demographics, medical comorbidities, history or radiation or chemotherapy, and PCF rate between the SATL and TLSC patients. A p-value <0.05 is considered significant. Figure 1. The exposed mucosa over the everted edge

of the pharyngeal closure is electrodesiccated.

Figure 2. The pharyngeal closure is reinforced by oversewing the suture line.

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TLSC Classic SATL Modified SATL

Rate of Pharyngocutaneous Fistula

Figure 3. Rate of PCF in TLSC, classic SATL, and modified SATL. There is a significant difference in the PCF rate between the classic SATL technique and the TLSC technique (p=0.019), but no significant difference in PCF between the modified SATL technique and the TLSC technique (p=1.00). A p-value of <0.05 is considered significant.