Comparative Study of Antiperistaltic vs Isoperistaltic Billroth II + Braun Anastomosis for Postoperative Reflux

December 10, 2017 updated by: Shanghai Minimally Invasive Surgery Center

A Superiority Study for Postoperative Reflux After Distal Gastrectomy With Antiperistaltic vs Isoperistaltic Billroth II + Braun Anastomosis

Postoperative gastroesophageal reflux is one of the most common complications of distal gastrectomy. With more attention paid on it by surgeons, several new operation methods have been practised. Among all these, distal gastrctomy with Billroth II + Braun anastomosis was reported to be an useful method to decrease postoperative reflux rate. Meanwhile, the direction of anastomotic peristalsis has also been reported to affect the anastomosis and thus make difference in reflux rate. We design this study to investigate the potential effect and the superiority of antiperistaltic vs isoperistaltic Billroth II + Braun reconstruction in distal gastrectomy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

214

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 Contact

  • Name: Minhua Zheng, M.D. PhD.
  • Phone Number: +86-13564119545
  • Email: zmhtiger@yeah.com

Study Contact Backup

  • Name: Jing Sun, M.D. PhD.
  • Phone Number: +86-13524284622
  • Email: sj11788@rjh.com

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

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pathologically diagnosed as gastric cancer before surgery
  • Clinical staging: cT1-4aN0-3M0
  • Postoperative evaluation concluded B-II B anastomosis
  • Consent assigned

Exclusion Criteria:

  • Diagnosed with other malignancies within 2 years
  • Gastric cancer with clinical staging: cT4b or M1
  • Women with pregnancy or breast-feeding
  • Emergency procedures
  • Consent not assigned

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Antiperistaltic
In this group patients undergo the distal gestrectomy with antiperistaltic Billroth II + Braun anastomosis
Procedure: Antiperistaltic Billroth II + Braun anastomosis
Laparoscopic distal gestrectomy will be applied with antiperistaltic Billroth II + Braun reconstruction
Active Comparator: Isoperistaltic
In this group patients undergo the distal gestrectomy with isoperistaltic Billroth II + Braun anastomosis
Procedure: Isoperistaltic Billroth II + Braun anastomosis
Laparoscopic distal gestrectomy will be applied with Isoperistaltic Billroth II + Braun reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Reflux Rate
Time Frame: 1 yrs
The rate of bile reflux within 1yrs postoperation
1 yrs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: 3yrs
3yrs DFS
3yrs
Overall survival
Time Frame: 3 yrs
3yrs OS
3 yrs
Surgery-related reflux gastritis rate
Time Frame: 1yrs
The rate of surgery-related reflux gastritis rate
1yrs
Surgery-related reflux esophagitis rate
Time Frame: 1 yrs
The rate of surgery-related reflux esophagitis rate
1 yrs

Collaborators and Investigators

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

Sponsor

Shanghai Minimally Invasive Surgery Center

Investigators

  • Study Director: Minhua Zheng, M.D. PhD., MISC, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong 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 (Anticipated)

January 1, 2018

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

December 10, 2017

First Submitted That Met QC Criteria

December 10, 2017

First Posted (Actual)

December 14, 2017

Study Record Updates

Last Update Posted (Actual)

December 14, 2017

Last Update Submitted That Met QC Criteria

December 10, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShanghaiMISC-B2+Braun

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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