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

Purpose

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.

Condition	Intervention
Esophageal Neoplasms Surgical Stomas	Other: hybrid everted esophagogastric anastomosis Other: the conventional hand-sewn anastomosis Other: a stapled anastomosis

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase III Study of Hybrid-everted Versus Hand-sewn of Stapled Esophagogastrostomy in Prevention of Anastomotic Stricture

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

U.S. FDA Resources

Further study details as provided by Sichuan University:

Primary Outcome Measures:

the incidence of anastomotic stricture [ Time Frame: three months ] [ Designated as safety issue: No ]
the anastomotic stricture is defined as the diameter of the anastomotic orifice <= 0.8 cm on esophagogram

Secondary Outcome Measures:

The grades of dysphagia [ Time Frame: three months ] [ Designated as safety issue: No ]
0:No dysphagia on solid diet
1. dysphagia on solid diet
2. dyspahgia on semi-solid diet
3. dysphagia on fluid diet
4. dysphagia with water swallowing
the grades of acid regurgitation [ Time Frame: three months ] [ Designated as safety issue: No ]
0:no reflux on semi-supine position
1. postprandial reflux on semi-supine position
2. reflux with empty stomatch on semi-supine position
3. postprandial reflux on upright position
4. reflux with empty stomach on upright positino
the clinicopathological parameters in relation to postoperative complications [ Time Frame: three months ] [ Designated as safety issue: No ]

Estimated Enrollment:	144
Study Start Date:	November 2007
Study Completion Date:	September 2008
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
HE group	Other: hybrid everted esophagogastric anastomosis Other Name: no other names
HS group	Other: the conventional hand-sewn anastomosis Other Name: no other names
SA group	Other: a stapled anastomosis Other Name: no other names

Detailed 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01139229

Sponsors and Collaborators

Sichuan University

Investigators

Study Chair:

Qi L Chen

the Department of Cardiothoracic Surgery, Huaxi Hospital of Sichuan University

More Information

Publications:

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.

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.

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.

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.

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.

Responsible Party:	Long-Qi Chen, Professor, Department of Thoracic and Cardiovascular Surgery, West China Hospital of Sichuan University
ClinicalTrials.gov Identifier:	NCT01139229 History of Changes
Other Study ID Numbers:	WCH20070901
Study First Received:	June 3, 2010
Last Updated:	June 7, 2010
Health Authority:	China: Ministry of Health

Keywords provided by Sichuan University:

Esophagogastrostomy
Circular everted anastomosis
Side-side anastomosis
Randomized clinical trial

Additional relevant MeSH terms:

Neoplasms
Esophageal Diseases
Esophageal Neoplasms
Constriction, Pathologic
Gastrointestinal Diseases
Digestive System Diseases

Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 22, 2013