Impact of the Techniques for Intrathoracic Esophagogastric Anastomosis on Outcome in Ivor-Lewis Oesophagectomy

December 21, 2015 updated by: Tianjin Medical University Cancer Institute and Hospital

Randomized Study of Intrathoracic Side-to-side Stapled Esophagogastric Anastomosis Versus Circular-Stapled Technique in Ivor-Lewis Oesophagectomy

The purpose of this study is to determine the safety and efficacy of the side-to-side stapled intrathoracic esophagogastric anastomosis in Ivor-Lewis Oesophagectomy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 3

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
    • Tianjin
      • Tianjin, Tianjin, China
        • Tianjin Medical University Cancer Institute and Hospital, Tianjin Key Laboratory of Cancer Prevention and Therapy

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

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cancer of the distal esophagus or gastroesophageal junction confirmed by biopsy (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) clinical stage I, II, or III.
  • Received no previous treatment for esophageal cancer
  • Adequate bone marrow, liver and kidney function
  • Patients must be able to understand the nature consent of the study and give written informed consent.

Exclusion Criteria:

  • Age < 18 years
  • History of significant heart disease
  • Inoperable on the basis of co-existent medical problems

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: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: side-to-side stapled esophagogastric anastomosis arm
Procedure: side-to-side stapled esophagogastric anastomosis
20 patients of distal esophageal cancer receive side-to-side stapled esophagogastric anastomosis in Ivor-Lewis oesophagectomy
ACTIVE_COMPARATOR: circular-stapled esophagogastric anastomosis arm
Procedure: circular-stapled esophagogastric anastomosis
20 patients of distal esophageal cancer receive circular-stapled esophagogastric anastomosis in Ivor-Lewis oesophagectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long and short outcome related with anastomoses
Time Frame: 3 year
Include anastomotic leakage,anastomotic stricture,regurgitation,heartburn, dumping syndrome and anastomoses diameter.
3 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life and function outcomes
Time Frame: 3 year
3 year

Collaborators and Investigators

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

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Investigators

  • Principal Investigator: YU zhen tao, M.D., Ph.D., Tianjin Medical University Cancer Institute and Hospital

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

January 1, 2011

Primary Completion (ANTICIPATED)

November 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

November 13, 2010

First Submitted That Met QC Criteria

November 15, 2010

First Posted (ESTIMATE)

November 16, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 22, 2015

Last Update Submitted That Met QC Criteria

December 21, 2015

Last Verified

September 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • TMU-CIH-ECC-001

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.

Clinical Trials on Esophageal Cancer

Clinical Trials on side-to-side stapled esophagogastric anastomosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe