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

June 7, 2010 updated by: Sichuan University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

144

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: HE group
Other: hybrid everted esophagogastric anastomosis
Other Names:
  • no other names
OTHER: HS group
Other: the conventional hand-sewn anastomosis
Other Names:
  • no other names
OTHER: SA group
Other: a stapled anastomosis
Other Names:
  • no other names

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of anastomotic stricture
Time Frame: three months
the anastomotic stricture is defined as the diameter of the anastomotic orifice <= 0.8 cm on esophagogram
three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The grades of dysphagia
Time Frame: three months

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
three months
the grades of acid regurgitation
Time Frame: three months

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
three months
the clinicopathological parameters in relation to postoperative complications
Time Frame: three months
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan University

Investigators

  • Study Chair: Qi L Chen, the Department of Cardiothoracic Surgery, Huaxi Hospital of Sichuan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (ACTUAL)

November 1, 2007

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

June 3, 2010

First Submitted That Met QC Criteria

June 7, 2010

First Posted (ESTIMATE)

June 8, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 8, 2010

Last Update Submitted That Met QC Criteria

June 7, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WCH20070901

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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