Comparing two surgical methods after stomach removal for cancer
Official title: Billroth-II Modified and Roux-en-Y Reconstruction After Distal Gastrectomy for Gastric Cancer: an Open-label Randomized Control Trial
Run by University Medical Center Ho Chi Minh City (UMC) · NCT05344339 · Data updated 2026-11-12
This study is testing if a new way of reconnecting the stomach after cancer surgery can help reduce acid reflux problems for patients without making the surgery longer or riskier.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 320 (estimated) |
| Sponsor | University Medical Center Ho Chi Minh City (UMC) Academic / other |
| Locations | 1 site (Ho Chi Minh City) |
| Status | Recruiting |
| Started | October 8, 2022 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | January 1, 2025 |
| Trial ID | NCT05344339 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 80 with confirmed gastric cancer who are indicated for radical distal gastrectomy.
✕Probably not a fit
Patients who are pregnant, have a high ASA score, or have a history of other cancers may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of a modified Billroth-II reconstruction method compared to the Roux-en-Y method following distal gastrectomy in patients with gastric cancer. The study aims to determine if the modified Billroth-II technique can reduce the incidence of reflux esophagitis without increasing operation time or complication rates. Participants will undergo radical distal gastrectomy and will be monitored for post-operative outcomes, including nutritional status and quality of life. The trial is designed to provide insights into the optimal surgical approach for gastric cancer treatment.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and quality of life for patients undergoing gastrectomy for gastric cancer.
How similar studies have gone: Previous studies have shown varying results regarding the effectiveness of different reconstruction methods, indicating that this approach is still under investigation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where it's running
-
University Medical Center Ho Chi Minh City
Ho Chi Minh City, Vietnam Recruiting
Study contacts
- Principal investigator: Long D Vo, MD, PhD — University Medical Center HCMC, VN
- Study coordinator: Long D. Vo, MD PhD
- Email: long.vd@umc.edu.vn
- Phone: +84918133915
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.