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

NCT00497549 | Completed

• 1 other identifier: GIS1/2004
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Esophagectomy; hand sewn anastomosis; side-to-side stapled

Outcome Measures

Primary Outcomes (1)

• Anastomotic leakage defined as a radiological defect at the anastomotic site or leakage of swallowed fluid out of the drain site or cervical wound.

  It was defined as a radiological defect at the anastomotic site or leakage of swallowed fluid out of the drain site or cervical wound

  within 7 days

Study Arms (2)

1

ACTIVE COMPARATOR

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.

Procedure: hand sewn

2

ACTIVE COMPARATOR

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: side-to-side stapled

Interventions

side-to-side stapled PROCEDURE

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.

Also known as: stapled

2

hand sewn PROCEDURE

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.

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient with resectable carcinoma of the mid or lower thoracic esophagus and gastroesophageal junction
• Benign esophageal lesion where esophageal resection was beneficial and feasible

You may not qualify if:

• Patients who had upper thoracic or cervical esophageal carcinoma
• Irresectable lesions (T4/M1)
• Prior gastric surgery
• Poor performance status

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Related Publications (3)

• Law S, Fok M, Chu KM, Wong J. Comparison of hand-sewn and stapled esophagogastric anastomosis after esophageal resection for cancer: a prospective randomized controlled trial. Ann Surg. 1997 Aug;226(2):169-73. doi: 10.1097/00000658-199708000-00008.

  PMID: 9296510 BACKGROUND

• Orringer MB, Marshall B, Iannettoni MD. Eliminating the cervical esophagogastric anastomotic leak with a side-to-side stapled anastomosis. J Thorac Cardiovasc Surg. 2000 Feb;119(2):277-88. doi: 10.1016/S0022-5223(00)70183-8.

  PMID: 10649203 BACKGROUND

• Saluja SS, Ray S, Pal S, Sanyal S, Agrawal N, Dash NR, Sahni P, Chattopadhyay TK. Randomized trial comparing side-to-side stapled and hand-sewn esophagogastric anastomosis in neck. J Gastrointest Surg. 2012 Jul;16(7):1287-95. doi: 10.1007/s11605-012-1885-7. Epub 2012 Apr 24.

  PMID: 22528571 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

SAH-Bcl9

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Tushar K Chattopadhyay, MS

  Deptt. GI Surgery, All India Institute of Medical sciences, New Delhi, India

  STUDY DIRECTOR

• Sundeep S Saluja, MS, MCh

  Deptt. GI Surgery, All India Institute of Medical sciences, New Delhi, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 5, 2007
• First Posted: July 6, 2007
• Study Start: July 1, 2004
• Primary Completion: January 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 10, 2011

Record last verified: 2011-04

Locations

IN (1)