Hybrid-everted Versus Hand-sewn or Stapled Esophagogastrostomy in Prevention of Anastomotic Stricture

Esophageal Neoplasms Clinical Trial

Official title:

Phase III Study of Hybrid-everted Versus Hand-sewn of Stapled Esophagogastrostomy in Prevention of Anastomotic Stricture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01139229
• Other study ID #: WCH20070901
• Status: Completed
• Phase: N/A
• First received: June 3, 2010
• Last updated: June 7, 2010
• Start date: November 2007
• Est. completion date: September 2008

Study information

• Verified date: March 2010
• Source: Sichuan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The investigators improved the hybrid everted esophagogastrostomy and expected to prevent the incidence of anastomotic stricture. The purpose of this study is to determine the clinical value of this kind of operation type, and analyzes the clinicopathological factors causing the postoperative complications.

Description:

This randomized clinical trial compared a hybrid everted esophagogastric anastomosis with conventional hand-sewn or stapled esophagogastrostomy for prevention of anastomotic stricture. The patients were completely randomized to receive either a hybrid everted esophagogastric anastomosis (HE group), or the conventional hand-sewn (HS group), or a stapled (SA group) anastomosis, after the removal of esophageal tumor. The primary outcome measured the incidence of anastomotic stricture at 3 months after the operation (defined as the diameter of the anastomotic orifice <= 0.8 cm on esophagogram), analyzed by intention-to-treat.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: September 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• pathologically diagnosed esophageal neoplasms

• undergoing the Esophagogastrostomy

Exclusion Criteria:

• the patients with previous the upper gastrointestinal tract surgery

• the esophageal carcinoma patients with previous neoadjuvant chemotherapy

• the esophageal carcinoma complicated other esophagogastric diseases

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Surgical Stomas

Intervention

Other:
• hybrid everted esophagogastric anastomosis

• the conventional hand-sewn anastomosis

• a stapled anastomosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan University

References & Publications (5)

Behzadi A, Nichols FC, Cassivi SD, Deschamps C, Allen MS, Pairolero PC. Esophagogastrectomy: the influence of stapled versus hand-sewn anastomosis on outcome. J Gastrointest Surg. 2005 Nov;9(8):1031-40; discussion 1040-2. — View Citation

Laterza E, de' Manzoni G, Veraldi GF, Guglielmi A, Tedesco P, Cordiano C. Manual compared with mechanical cervical oesophagogastric anastomosis: a randomised trial. Eur J Surg. 1999 Nov;165(11):1051-4. — View Citation

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. — View Citation

Moher D, Schulz KF, Altman D; CONSORT Group. The CONSORT Statement: revised recommendations for improving the quality of reports of parallel-group randomized trials 2001. Explore (NY). 2005 Jan;1(1):40-5. — View Citation

Zhu ZJ, Zhao YF, Chen LQ, Hu Y, Liu LX, Wang Y, Kou YL. Clinical application of layered anastomosis during esophagogastrostomy. World J Surg. 2008 Apr;32(4):583-8. doi: 10.1007/s00268-007-9396-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of anastomotic stricture	the anastomotic stricture is defined as the diameter of the anastomotic orifice <= 0.8 cm on esophagogram	three months	No
Secondary	The grades of dysphagia	0:No dysphagia on solid diet; dysphagia on solid diet; dyspahgia on semi-solid diet; dysphagia on fluid diet; dysphagia with water swallowing	three months	No
Secondary	the grades of acid regurgitation	0:no reflux on semi-supine position; postprandial reflux on semi-supine position; reflux with empty stomatch on semi-supine position; postprandial reflux on upright position; reflux with empty stomach on upright positino	three months	No
Secondary	the clinicopathological parameters in relation to postoperative complications		three months	No