The Optimal Width of Gastric Conduit for Minimally Invasive Esophagectomy: Wide or Narrow?

February 7, 2013 updated by: Tan, Lijie, Fudan University

Study on the Difference of Anastomotic Leakage Ratio Between Wide and Narrow Gastric Conduit During Minimally Invasive Esophagectomy

The study hypothesized that a narrow gastric conduit(less than 3cm in width) would minimize anastomotic leakage following minimally invasive esophagectomy. Therefore we raise this random-controlled research, and investigate the leakage ratio from different widths of gastric conduit formed during the operation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients underwent minimally invasive esophagectomy in Zhongshan Hospital of Fudan University will be enrolled and be assigned to wide or narrow gastric conduit group randomly. Intra-operative blood supply and vascular SaO2 will be observed during the operation, and the rate of anastomotic leakage, together with its clinical details will be recorded in the two groups.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200032
        • Recruiting
        • Division of Thoracic Surgery, Zhongshan Hospital of Fudan University
        • Contact:
        • Sub-Investigator:
          • Hao Wang, MD

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients underwent minimally invasive esophagectomy(three-hole procedure)
  2. Clinical Staged T1-3N0M0 esophageal cancer patients or: patients who were restaged as T1-3N0M0 esophageal cancer after neo-adjuvant therapy

Exclusion Criteria:

  1. With previous cancer history
  2. Severe Co-morbidity

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: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Narrow Gastric Conduit
The group in which narrowed gastric conduit will be performed during minimally invasive esophagectomy
Procedure: Narrowed Gastric Conduit
The gastric conduit will be formed much narrower in the intervention arm during minimally invasive esophagectomy
Other Names:
  • Narrowed Gastric Tube
Experimental: Wide Gastric Conduit
The group in which widened gastric conduit will be performed during minimally invasive esophagectomy
Procedure: Widened Gastric Conduit
A widened gastric tube will be formed during the surgery
Other Names:
  • Wide Gastric Tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The anastomotic leakage rate
Time Frame: the anastomotic leakage of participants will be followed for the duration of hospital stay, an expected average of 2 weeks
The anastomotic leakage is a severe complication following minimally invasive esophagectomy. The definition of anastomotic leakage is determined as per the STS (SOCIETY OF THORACIC SURGEONS) database.
the anastomotic leakage of participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Collaborators and Investigators

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

Sponsor

Fudan University

Investigators

  • Study Director: Lijie Tan, MD, Fudan University

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

September 1, 2012

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

September 22, 2012

First Submitted That Met QC Criteria

September 28, 2012

First Posted (Estimate)

October 1, 2012

Study Record Updates

Last Update Posted (Estimate)

February 11, 2013

Last Update Submitted That Met QC Criteria

February 7, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZSchest2012001

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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