Comparing two surgical methods after stomach removal for cancer
Billroth-II Modified and Roux-en-Y Reconstruction After Distal Gastrectomy for Gastric Cancer: an Open-label Randomized Control Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Medical Center Ho Chi Minh City (UMC) Academic / other |
| Locations | 1 site (Ho Chi Minh City) |
| Trial ID | NCT05344339 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with confirmed gastric cancer who are indicated for radical distal gastrectomy.
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.
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 performed: Previous studies have shown varying results regarding the effectiveness of different reconstruction methods, indicating that this approach is still under investigation.
Eligibility criteria
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 this trial is running
Ho Chi Minh City
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.