Trial Comparing Side-to-Side Stapled and Hand-sewn Esophagogastric Anastomosis in Neck

Summary

Carcinoma esophagus is a common cause of dysphagia. Once dysphagia occurs, a majority of the tumours are advanced. Most of them would require some form of treatments for control of dysphagia and to improve the quality of life. Surgery is the only hope for cure. It requires complete removal of the esophagus. After removal of the esophagus, the stomach can be used as a substitute for the esophagus. Anastomosis can be done in the neck either by a hand-sewn or by a stapled anastomosis. The anastomotic leak rates reported in studies comparing hand-sewn with stapled anastomosis are variable. Many non-randomized studies have reported leak rate as low as 5% with stapled technique. However, the stricture rate is higher in the stapled group. There is no randomized study comparing hand-sewn anastomosis with side-to-side stapled anastomosis. Hence, the investigators planned a randomized trial comparing the anastomotic sequelae after hand-sewn anastomosis with stapled anastomosis in the neck.

Conditions

• Esophageal Cancer

Interventions

PROCEDURE

side-to-side stapled

5 cm of the mobilized stomach will be placed in the neck. Three interrupted sutures will be taken between the posterior wall of esophagus and anterior wall of stomach. A 1.5 cm gastrotomy will be made. Two stay sutures will then be taken, one at the anterior corner of esophagus and another between posterior corner of esophagus and the middle of the gastrotomy. The stapler device (Endopath, EZ45) will be introduced.The staple cartridge will then be rotated so that the posterior wall of the esophagus and the anterior wall of the stomach will align in a parallel manner and fire the stapler. A 16F nasogastric tube will be placed across the anastomosis and the anterior edges of the gastrotomy and open esophagus will be approximated with interrupted 3-0 silk.

PROCEDURE

hand sewn

A proper site on the anterior wall of stomach away from the stapled line approximately 2 cm below the highest point of the gastric conduit will be anastamosed to esophagus Posterior interrupted seromuscular sutures will be taken with 3-0 silk. The stomach will then be opened transversely (2.5 to 3 cm long). Interrupted stitches with full thickness of the stomach and esophagus will be placed to achieve mucosa to mucosa approximation. A 16F nasogastric tube will then be placed across the anastomosis into the intrathoracic stomach. The anterior wall of the anastomosis will be completed in a manner similar to posterior wall.

Sponsors & Collaborators

• All India Institute of Medical Sciences

  lead OTHER

Principal Investigators

• Tushar K Chattopadhyay, MS · Deptt. GI Surgery, All India Institute of Medical sciences, New Delhi, India

• Sundeep S Saluja, MS, MCh · Deptt. GI Surgery, All India Institute of Medical sciences, New Delhi, India

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-07-31

Primary Completion

2010-01-31

Completion

2010-12-31

Countries

• India

Study Locations