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  Table of Contents  
Year : 2015  |  Volume : 52  |  Issue : 3  |  Page : 376-380

Evaluation of stapled closure following laryngectomy for carcinoma larynx in an Indian tertiary cancer centre

1 Department of Surgical Oncology, Regional Cancer Centre, Trivandrum, India
2 Department of Cancer Registry, Regional Cancer Centre, Trivandrum, India

Date of Web Publication18-Feb-2016

Correspondence Address:
B T Varghese
Department of Surgical Oncology, Regional Cancer Centre, Trivandrum
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/0019-509X.176728

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 » Abstract 

Background And Aim: Stapling devices are used for pharyngeal closure after laryngectomy for the past few decades although it has not gained wide acceptance. This study is aimed at evaluating the role of stapler in pharyngeal closure after laryngectomy. Methods: Thirty consecutive patients who underwent stapled laryngectomy at our institution from October 2004 to February 2008 were evaluated retrospectively. Linear stapler (Proximate TX 60; Ethicon Inc.) was used for closure of neopharynx. Results: There were 28 males and 2 females with mean age of 54.5 years (54.5 ± 11.2). Nineteen of these patients (63.3%) had salvage laryngectomy and two patients (6.7%) had laryngectomy for a second primary tumor. Twenty-eight patients had total laryngectomy (TL), whereas two had extended TL. Eight patients had salivary leak (26.7%). Of these, 6 (75%) had prior radiation. All salivary leaks except one were managed conservatively. Follow-up ranged from 7 to 54 months (median: 21 months). Seven patients (23.3%) developed recurrence, six at the stoma, of which 5 (83.3%) had initial extension of disease to the subglottis. Four-year disease-free survival was 54.4%. Conclusion: Pharyngeal closure by linear stapler is an efficient and safe method of fashioning the neopharynx after laryngectomy with no added risk of occurrence of pharyngocutaneous fistula in primary and salvage laryngectomies.

Keywords: Laryngectomy, pharyngeal closure, pharyngocutneous fistula, stapled laryngectomy

How to cite this article:
Babu S, Varghese B T, Iype E M, George P S, Sebastian P. Evaluation of stapled closure following laryngectomy for carcinoma larynx in an Indian tertiary cancer centre. Indian J Cancer 2015;52:376-80

How to cite this URL:
Babu S, Varghese B T, Iype E M, George P S, Sebastian P. Evaluation of stapled closure following laryngectomy for carcinoma larynx in an Indian tertiary cancer centre. Indian J Cancer [serial online] 2015 [cited 2021 May 9];52:376-80. Available from: https://www.indianjcancer.com/text.asp?2015/52/3/376/176728

 » Introduction Top

Cancer of larynx constitutes 1.9-7% of all head and neck cancers.[1] The management of advanced tumors of the larynx is by a multidisciplinary approach, which often involves laryngectomy followed by either radiotherapy or chemoradiation. Even when a non-surgical combination of treatment is feasible, laryngectomy may be required as a salvage procedure for treatment failures.

The major complication after a laryngectomy is pharyngocutaneous leak which occurs in 2.6-65.5% of the cases.[2],[3],[4],[5],[6] The factors responsible for the occurrence of leak have been studied by various authors. The method of closure of the pharynx is considered one of the factors.[4],[7] The neopharynx is closed either in a single layer or in two layers with constrictor muscle as second layer or even in three layers with an intermediate layer of connective tissue between the mucosal and the muscle layers. A good closure is needed for prevention of salivary leak and early rehabilitation of swallowing.

Metallic stapling devices are being used extensively in gastrointestinal anastomosis. The same stapler is adopted for closing the neopharynx after a laryngectomy. Linear stapler pharyngoplasty is a novel technique employed for pharyngeal closure which is gaining popularity. This study aims to evaluate the efficacy of pharyngeal closure by stapler in controlling the disease and complications of laryngectomy.

 » Methods Top

One hundred and twenty-eight laryngectomies were performed from October 2004 to February 2008 at our institution. Out of these, 30 patients underwent pharyngeal closure using the linear stapler (Proximate TX 60; Ethicon Inc.). Patient's demographic data, details of surgical procedure, post-operative complications, histopathological findings, staging, and pattern of recurrence were collected from the medical records database. The selection criteria were based on the site and extent of the tumor. Only those lesions confined to the larynx with no extension into the pyriform fossa or post-cricoid area posteriorly or vallecula superiorly were selected for closure with stapler. These included both primary cases and salvage cases. Direct laryngoscopy and computerized tomography were done to evaluate the extent of disease pre-operatively. All the patients had histopathologically proven squamous cell carcinoma.

Surgical technique

The initial steps of laryngectomy are performed as in a standard procedure. The larynx is skeletonized taking care not to open the pharynx. Superiorly, the suprahyoid muscles are incised till the mucosa of the vallecula. The greater horn of hyoid bone and the greater cornu of the thyroid cartilage are well exposed. It is advised to preserve the thyrohyoid ligament, which will help in easier application of the stapler by preventing entrapment of the hyoid in the stapler line. The trachea is now transected at the required level so that an adequate inferior margin is attained visualizing any subglottic extend of the tumor. The trachea is now separated meticulously from the esophagus from below till the entire laryngotracheal framework is separated from the pharyngo-esophageal mucosa. A cricoid hook is inserted through the tracheal lumen into the larynx to retract the epiglottis so that it does not get caught within the jaws of the stapler. Epiglottis can be palpated at the suprahyoid region and is pushed downwards to enable the catch. If the epiglottis is short, thick, and edematous, an Allis forceps is used instead of the cricoid hook to grasp and retract the epiglottis. Now the linear stapler is applied between the larynx and the pharynx taking care that no other soft tissue, the greater horn of hyoid, or the ala of thyroid cartilage are caught within the jaws of the stapler line [Figure 1]. The stapler is then fired and the laryngeal specimen is separated by incising flush with a scalpel on the rim of stapler jaws.
Figure 1: The technique of application of the linear stapler. The epiglottis is retracted away from the stapling line by a Cricoid hook

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Primary tracheo-esophageal puncture (TEP) can be made with care after application of the stapler. An esophagoscope is introduced through the mouth and puncture is made with the trocar and canula as is done in secondary TEP procedures.

Feeding tube (Ryles tube) is introduced at this stage to help in post-operative feeding. If the feeding tube was in place before the surgery, it should be removed before application of the stapler and reintroduced after the procedure.

The end points of interest in this study were surgical complications and disease-free survival. Fisher's exact, or the χ2 test was used to find risk factors for complications and disease-free survival. Comparisons of survival time between strata of categorical variables were made by the Kaplan-Meier method and log-rank test. The results were considered significant when the P value was < 0.05. All computations were performed using SPSS statistical software, version 11.0.

 » Results Top

The age of the group ranged from 28 to 74 years with mean age of 54.47 (SD ± 11.2) years. The patient and disease characteristics are given in [Table 1].
Table 1: Patient and disease characteristics

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Twenty-one patients had salvage laryngectomies for recurrences after prior radiation or chemoradiation. Majority of the patients (76.7%) belonged to stage III and above. All the patients taken up for primary surgery and the patient who underwent neoadjuvant chemotherapy had stage IV disease. Two patients, who had recurrence, also had stage IV disease. Seven of the recurrent lesions were diagnosed in stages I and II, whereas 12 patients belonged to stage III. The post-radiotherapy edema masked an early recurrence in these patients. The salvage surgeries were done after a mean period of 14 months after radiotherapy.

Twenty-eight patients underwent total laryngectomy (TL), whereas two patients had to undergo extended laryngectomy with excision of the involved overlying skin. Neck dissection was done in 15 patients. Six patients underwent bilateral neck dissection, whereas nine underwent ipsilateral neck dissection [Table 2]. Six patients had pathologically positive ipsilateral lymph node metastasis. None of the contralateral lymph nodes were positive on histopathological examination. Two patients had a close margin of 2 mm.
Table 2: Details of surgery

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All the subjects were counseled regarding voice restoration with TEP, but 20 patients opted out due to financial constraints. Voice was restored in 10 patients. Eight of these had surgical rehabilitation with Tracheo-esophageal puncture, three at the time of laryngectomy and five secondarily. Two patients preferred electrolarynx for voice rehabilitation.

Oral feeding was started after 48 h in the primary surgery patients and after 4 days in salvage surgery patients. The swallowing habits were adequately restored in all the patients except two, who developed stenosis, 8 and 12 months post-operatively. Eight patients (26.7%) developed salivary leak. This included those cases with very minimal leak which resolved within a week. Six (28.6%) out of these had prior radiotherapy, whereas only one patient (12.5%) from the primary surgery group developed a salivary leak [Table 3]. Increased suction drainage with suspicion of presence of saliva and development of collection beneath the skin after drain removal were the forerunners of a frank pharyngocutaneous leak. One of the patients required suturing to close the fistula which persisted for more than 3 months. All the others were treated conservatively with appropriate antibiotics and pressure bandaging. In one case, a small localized fistulous track could be documented along the center of the stapled line on modified barium swallow before the conservative treatment.
Table 3: Factors influencing salivary leak

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Proximity of the stapler line (close Margin) to the tumor was a significant factor for occurrence of salivary leak (P = 0.015). However, the two patients who had close (2 mm) margins along the stapler line did not recur locally, perhaps due the planned adjuvant treatment they had received. Advanced T status at the time of surgery had a higher salivary leak rate with borderline significance (P = 0.061). The addition of neck dissection did not have any influence on the occurrence of salivary leak [Table 3].

Stomal stenosis was seen in one patient. There was no relation of the occurrence with salivary leak. Seven patients (23.3%) developed local recurrence during follow-up, three patients (37.5%) in the primary surgery group, four patients (25%) in the post-radiation group out of which two (40%) patients received chemotherapy in addition to radiotherapy. Six of these patients recurred in the stoma and one patient in the neopharynx. Five patients among them had subglottic extension at initial presentation which was a factor approaching statistical significance affecting recurrence in our series (P value 0.058).

The follow-up period ranged from 7 to 54 months (median: 21 months). Overall 4 year disease-free survival was 54.39% [Figure 2]. Four year disease-free survival for the primary surgery group was 70.0% and 55.5% for the salvage surgery group [Figure 3].
Figure 2: Overall disease-free survival

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Figure 3: Disease-free survival (primary versus salvage)

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 » Discussion Top

Stapler devices had been in use in general surgery from the latter half of the twentieth century. The technique was developed initially by Humer Hultl who is known as the father of stapler surgery.[8] The experience gained in using these mechanical closure devices was extended to head and neck, initially for Zenkers diverticulum.[9] Linear stapler was first used for laryngectomy by Lukyanchenko in 1971.[10] There were many attempts in different parts of the world to try this device in this new setting. The largest experience with stapled closure of the pharynx after laryngectomy was reported by Lev Bedrin in over 1400 cases.

Several techniques of stapled pharyngeal closure have been described. Talmi et al.,[11] described an open technique in which the mucosal edges are closed using a stapler after a standard laryngectomy. This technique enables assessment of tumor extent and margins which is not possible in a closed technique. In the closed technique described by Bedrin, the larynx is skeletonized, trachea is cut and then the stapler is applied between the larynx and the pharynx.[10] It provides a simple and quick water tight closure of the pharynx without salivary contamination and good hemostasis. In addition, patients recovered good swallowing without increase in fistula and recurrence rates. A modification of the closed technique employs two TLC 75 linear cutter instead of the one linear stapler for laryngeal resection and pharyngeal closure simultaneously without any wound contamination and theoretically reducing the chance of tumor seedling.[12] Altissimi and Frenguelli,[13] developed the semi-closed technique in which a mini pharyngostomy is done in the vallecula before firing the stapler to retract the suprahyoid part of the epiglottis so that it is not caught between the jaws of the stapler. We have used the closed technique as described by Bedrin in all our cases.

The indications for the closed technique are endolaryngeal tumors without extension to the vallecula, pyriform sinus, or post-cricoid region. With the advances in organ preservation protocols, the need for laryngectomy has decreased and primary laryngectomies are only done for advanced tumors with extralaryngeal spread. Even advanced T4 tumors without hypopharyngeal or vallecular extension can be taken up for stapled laryngectomy. Salvage laryngectomy is done for recurrences after organ preservation treatment. Majority of these recurrences are identified in early stages during the surveillance period and partial laryngectomies could be used to salvage some of these cases. Those tumors which are not amenable to partial laryngectomy due to severe edema and are endolaryngeal can be considered for a stapled closure. Careful pre-operative assessment with endoscopy and imaging is essential for proper selection of patients for this procedure. In our series, seven patients (23.3%) with T1 or T2 recurrent disease at the primary site at the time of surgery had to undergo TL due to severe edema.

Oral feeding can be initiated early after stapled laryngectomy. Sofferman,[14] in his series of 19 patients, started tube feeding at a mean period of 5 days. Ahsan et al., in small series of 10 patients started oral fluids after 48 h in non-irradiated patients and after 72 h in those who received prior radiotherapy without any increase in complications. In our series, tube feeding was started after 12 h and oral feeding after 2 days in those who underwent primary surgery and after 4 days in those who had prior radiotherapy or chemoradiotherapy. The relationship between the days of onset of feeding with development of fistula is not shown in any series. Laryngectomized patients usually have a good swallowing reflex and swallow saliva without any problem as soon as they recover from anesthesia. Hence, early oral feeding is considered safe.

The incidence of pharyngocutaneous fistula (PCF) after TL ranges from 2.6% to 65.5%.[2],[3],[4],[5],[6] Patients who undergo prior radiotherapy and chemoradiotherapy have higher rates for PCF. The reported incidence of PCF after stapled laryngectomy ranges from 0 to 14%.[10],[11],[12],[13],[14] The patient numbers in all these series were small. In Bedrin's large series, the incidence of PCF after primary surgery was 5% and 19.4% after salvage surgery and 31% of patients with fistula required surgical closure. The overall incidence of PCF in our series was 26.7%, the incidence being 12.5% after primary surgery, 25% after prior radiation, and 40% after prior chemoradiation. These rates are higher than the rates reported in other series. This could be due to poor general health and nutritional status of our patients, majority are from the lower socioeconomic strata of society.

Goncalves et al.,[15] compared the PCF in mechanical closure with manual closure and found significant reduction with stapled closure (06.7% vs. 36.7%). Our experience shows that there is no reduction in the rate of pharyngocutaneous leak with this technique. The severity of the leak is less in stapled closures, even in salvage laryngectomies and these leaks required only conservative management. Altissimi et al.,[13] with their 15 years experiences had 1.8% leak rate in non-radiated patients and 13.1% radiated patients. Analysis of factors causing fistula was studied by Dedivitis et al.,[5] who found no association with stapled closure. Margin positivity was found to be an important factor for PCF by Saki et al.,[6] which was a significant factor in our series also.

The recurrence rate after primary laryngectomy with standard technique was 27% and after salvage laryngectomy was 44% in a study by Nikolou et al.[16] Similar results were seen in our series. The disease-free survival at 4 years was 54.39% for the whole group [Figure 2]. The patients who underwent primary surgery had better 4 year disease-free survival than the patients who underwent salvage laryngectomy [Figure 3].

 » Conclusion Top

Though the use of stapler has been found to reduce the operating time, its benefit in reducing the post-laryngectomy PCF and recurrence rate is still not clear. Our finding further strengthens the observation and belief that stapled closure of the pharynx does not carry any additional risk to the development of PCF or to an increased recurrence rate.

 » References Top

Yeole BB. Trends in incidence of head and neck cancers in India. Asian Pac J Cancer Prev 2007;8:607-12.  Back to cited text no. 1
Paydarfar JA, Birkmeyer NJ. Complications in head and neck surgery: A meta-analysis of postlaryngectomy pharyngocutaneous fistula. Arch Otolaryngol Head Neck Surg 2006;132:67-72.  Back to cited text no. 2
Ganly I, Patel S, Matsuo J, Singh B, Kraus D, Boyle J, et al. Postoperative complications of salvage total laryngectomy. Cancer 2005;103:2073-81.  Back to cited text no. 3
Cavalot AL, Gervasio CF, Nazionale G, Albera R, Bussi M, Staffieri A, et al. Pharyngocutaneous fistula as a complication of total laryngectomy: Review of the literature and analysis of case records. Otolaryngol Head Neck Surg 2000;123:587-92.  Back to cited text no. 4
Dedivitis RA, Ribeiro KC, Castro MA, Nascimento PC. Pharyngocutaneous fistula following total laryngectomy. Acta Otorhinolaryngol Ital 2007;27:2-5.  Back to cited text no. 5
Saki N, Nikakhlagh S, Kazemi M. Pharyngocutaneous fistula after laryngectomy: Incidence, predisposing factors, and outcome. Arch Iran Med 2008;11:314-7.  Back to cited text no. 6
Wang CP, Tseng TC, Lee RC, Chang SY. The techniques of nonmuscular closure of hypopharyngeal defect following total laryngectomy: The assessment of complication and pharyngoesophageal segment. J Laryngol Otol 1997;111:1060-3.  Back to cited text no. 7
Zeebregts CJ, Heijmen RH, van den Dungen JJ, van Schilfgaarde R. Non-suture methods of vascular anastomosis. Br J Surg 2003;90:261-71.  Back to cited text no. 8
Halevy A, Sadé J. The use of thoracoabdominal staplers in ENT surgery. Arch Otorhinolaryngol 1983;237:185-90.  Back to cited text no. 9
Bedrin L, Ginsburg G, Horowitz Z, Talmi YP. 25-year experience of using a linear stapler in laryngectomy. Head Neck 2005;27:1073-9.  Back to cited text no. 10
Talmi YP, Finkelstein Y, Gal R, Shvilli Y, Sadov R, Zohar Y. Use of a linear stapler for postlaryngectomy pharyngeal repair: A preliminary report. Laryngoscope 1990;100:552-5.  Back to cited text no. 11
Ahsan F, Ah-See KW, Hussain A. Stapled closed technique for laryngectomy and pharyngeal repair. J Laryngol Otol 2008;122:1245-8.  Back to cited text no. 12
Altissimi G, Frenguelli A. Linear stapler closure of the pharynx during total laryngectomy: A 15-year experience (from closed technique to semi-closed technique). Acta Otorhinolaryngol Ital 2007;27:118-22.  Back to cited text no. 13
Sofferman RA, Voronetsky I. Use of the linear stapler for pharyngoesophageal closure after total laryngectomy. Laryngoscope 2000;110:1406-9.  Back to cited text no. 14
Gonçalves AJ, de Souza JA Jr, Menezes MB, Kavabata NK, Suehara AB, Lehn CN. Pharyngocutaneous fistulae following total laryngectomy comparison between manual and mechanical sutures. Eur Arch Otorhinolaryngol 2009;266:1793-8.  Back to cited text no. 15
Nikolaou A, Markou K, Petridis D, Vlachtsis K, Nalbantian M, Daniilidis L. Factors influencing tumor relapse after total laryngectomy. B-ENT 2005;1:1-10.  Back to cited text no. 16


  [Figure 1], [Figure 2], [Figure 3]

  [Table 1], [Table 2], [Table 3]

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