Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID05344339

Comparison of Billroth-II Modified and Roux-en-Y Reconstruction After Distal Gastrectomy for Gastric Cancer: A Randomized Controlled Study

Led by University Medical Center Ho Chi Minh City (UMC) · Updated on 2025-01-01

320

Participants Needed

1

Research Sites

325 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare two reconstruction methods, Billroth-II modified and Roux-en-Y, used after distal gastrectomy surgery for patients with gastric cancer. The study investigates which method better reduces reflux esophagitis one year after surgery, as the best reconstruction technique remains uncertain. Different methods may affect complications, nutritional status, and quality of life after surgery. Participants will undergo distal gastrectomy followed by either the Billroth-II modified reconstruction, which includes 3-5 sutures connecting the afferent loop to the stomach remnant to reduce bile reflux, or the Roux-en-Y reconstruction. These methods are compared in an open-label randomized controlled trial to evaluate their effectiveness in preventing reflux and improving outcomes. During the study, patients will be monitored for reflux esophagitis at 12 months after surgery. Researchers will assess complications, nutritional status, and quality of life changes related to the reconstruction methods. Participants must agree to the study and provide written consent, with involvement lasting through surgery and follow-up evaluations to measure the primary outcome.

CONDITIONS

Official Title

Billroth-II Modified Versus Roux-en-Y After Distal Gastrectomy for Gastric Cancer

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients confirmed with gastric cancer
  • Indicated for radical distal gastrectomy (cT1 to cT4a, any N, M0; according to AJCC/UICC 8th TNM staging for gastric cancer)
  • Age from 18- to 80-year-old
  • Agreed to participate in study with written inform consent
Not Eligible

You will not qualify if you...

  • Pregnant patients
  • An American Society of Anesthesiology (ASA) score of higher than 4
  • Concurrent cancer or history of previous other cancers
  • Previous gastrectomy
  • Complications including bleeding, perforation required emergency gastrectomy

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Trial Site Locations

Total: 1 location

1

University Medical Center Ho Chi Minh City

Ho Chi Minh City, Vietnam, 700000

Actively Recruiting

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Research Team

L

Long D. Vo, MD PhD

T

Thong Q. Dang, MD, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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