NCT06768164RecruitingPhase 3
Quality of Life After Billroth II or Roux-en-Y for Gastric Cancer
Health-Related Quality Of Life After Partial Gastrectomy for Gastric Cancer: Comparison of Reconstruction by Billroth II or Roux-en-Y. A Randomized, Comparative, Multicentric, Single-blinded Study
Source: ClinicalTrials.gov · Last updated 20 May 2026
Brief summary (registry, in English)
The treatment of a local distal gastric cancer remains surgical before or after chemotherapy. Partial gastrectomy is recommended for distal location cancer The recommendations for restoring continuity are less evident. There are two main techniques: the Roux-En-Y (REY) requiring 2 anastomoses (gastro-jejunostomy and entero-enterostomy) and the Billroth 2 (B2) with a single anastomosis (gastro-jejunostomy). The choice remains matter of debate. There was no difference on the global health status score from the QLQ-C30 questionnaire. However, the health-related quality of life (HRQoL) was significantly improved only in the REY group between pre- and post-gastrectomy. A significant difference for endoscopic gastritis in favor of the REY group was reported. The purpose of this study is to determine which surgical technique improve the health related quality of life after distal gastrectomy.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 24 Sept 2024
- Start date
- 20 Mar 2026
- Primary completion date
- Apr 2031
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06768164
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 250
- From 20 Mar 2026 to the primary completion date, Apr 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Palliative surgery patients
Other illness
- Patients deprived of liberty by judicial or administrative decision and patients under psychiatric care (admitted to a health or social care establishment)
Age
- Women of childbearing age without effective contraception
Other
- Patients with preoperative peritoneal metastasis or distant metastasis
- Patients under tutorship or curatorship and protected adults
- Patients on AME (Aide Médicale de l'Etat = State Medical Assistance)
- Patients unable to give their consent
- Pregnant or breastfeeding women
Who the study is looking for
- Patients aged ≥ 18 years, men or women
- Patients treated for adenocarcinoma of the antrum accessible to a surgical treatment with curative intent by distal gastrectomy. If patients present a linitis plastica, negative proximal and distal margin will be evaluated at the beginning of the surgery before randomization in order to perform a R0 resection
- Patients with a registration in a national health care system (CMU included) (registered or being a beneficiary of such a scheme)
- Patients able to understand and fulfill questionnaires in French language
- Patients having given their written informed consent prior to participation in the study
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Saint-Antoine Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.