Actively Recruiting
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
Eligibility Criteria
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
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
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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