A Clinical Study of the Effects of Modified BII+Braun on Quality of Life After for Distal Gastric Cancer

October 4, 2022 updated by: Xue Yingwei

A Single-center, Randomized, Controlled Clinical Study of the Effects of Modified and Traditional BII+Braun Digestive Tract Reconstruction Methods on Quality of Life After Radical Gastrectomy for Distal Gastric Cancer

The jejunum of the input segment is properly ligated with double line 7 at 3-5cm from the anastomotic site, and the jejunum of the output segment is extended to 30cm

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The T1-4a N0-3 M0 gastric adenocarcinoma patients were used to evaluate whether the quality of life after modified BII+Braun digestive tract reconstruction was superior to the traditional BII+Braun digestive tract reconstruction

Study Type

Interventional

Enrollment (Actual)

592

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
    • Helongjiang
      • Harbin, Helongjiang, China, 150001
        • Gastrointestinal surgery of the affiated tumor hospital

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18<age<75
  • Gastric lesions were diagnosed as gastric adenocarcinoma by endoscopic biopsy
  • The preoperative clinical stage is T1-4a,N0-3,M0(According to AJCC- 7th TNM tumor stage)
  • It is expected that the results of R0 surgery can be obtained by performing distal gastrectomy and D2 lymph node dissection
  • Preoperative ECOG performance status score 0/1
  • Nutrition risk screening（NRS2002）
  • Preoperative ASA score I-III
  • Patient informed consent

Exclusion Criteria:

  • Pregnancy or breastfeeding women
  • Severe mental illness
  • History of upper abdominal surgery
  • History of gastric surgery (including ESD/EMR for gastric cancer)
  • 3 years of history of other malignant diseases；
  • Gastric cancer patients who have undergone neoadjuvant treatment or recommend neoadjuvant treatment
  • A history of unstable angina or myocardial infarction within 6 months
  • History of cerebral infarction or cerebral hemorrhage within 6 months
  • There is a history of sustained systemic corticosteroid treatment within 1 month
  • Needs simultaneous surgical treatment of other diseases；
  • Gastric cancer complications (bleeding, perforation, obstruction) require emergency surgery
  • Pulmonary function test FEV<1 predicted value 50%

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
Active Comparator: modified BII+Braun
The jejunum of the input segment is properly ligated with double line 7 at 3-5cm from the anastomotic site, and the jejunum of the output segment is extended to 30cm
Procedure: modified BII+Braun
modified BII+Braun digestive tract reconstruction
No Intervention: traditional BII+Braun
traditional BII+Braun digestive tract reconstruct

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of quality of life
Time Frame: The quality of life questionnaire was conducted at six months after surgery.
The GSRS scoring system was used to understand the functional status of the digestive tract and its impact on quality of life in postoperative patients .The GSRS scoring system was 0-3, with 0 being the mildest and 3 being the most severe
The quality of life questionnaire was conducted at six months after surgery.

Collaborators and Investigators

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

Sponsor

Xue Yingwei

Investigators

  • Study Director: Yingwei Xue, doctor, Director of Gastrointestinal surgery

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 (Actual)

April 1, 2018

Primary Completion (Actual)

October 1, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

July 29, 2018

First Submitted That Met QC Criteria

August 7, 2018

First Posted (Actual)

August 10, 2018

Study Record Updates

Last Update Posted (Actual)

October 5, 2022

Last Update Submitted That Met QC Criteria

October 4, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-02-R

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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