Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric (Cardia, Body) Cancer | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Billroth 2 (B2) | Procedure | — | UNRESOLVED |
| Roux-En-Y (REY) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Billroth 2 (B2)
- interventionNames
- Procedure: Billroth 2 (B2)
- type
- EXPERIMENTAL
- label
- Roux-En-Y (REY)
- interventionNames
- Procedure: Roux-En-Y (REY)
Primary outcomes (1)
- measure
- HRQol with 3 targeted dimensions
- timeFrame
- One year post-surgery
- description
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, OesophagoGastric 25 (EORTC QLQ-OG25) at 1 year post surgery with 3 targeted dimensions : eating, reflux, pain and discomfort. Health-related Quality of life (HRQoL) will be considered as being improved in one arm if at least one of the 3 targeted dimensions is significantly improved without a significantly deterioration for the other 2 targeted dimensions : * Eating restrictions : \[0-100\]. * Reflux : \[0-100\]. * Pain and discomfort : \[0-100\]. If high scores = more problems.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Patients with preoperative peritoneal metastasis or distant metastasis * Palliative surgery patients * Patients under tutorship or curatorship and protected adults * Patients on AME (Aide Médicale de l'Etat = State Medical Assistance) * Patients deprived of liberty by judicial or administrative decision and patients under psychiatric care (admitted to a health or social care establishment) * Patients unable to give their consent * Pregnant or breastfeeding women * Women of childbearing age without effective contraception
References
Publications (0)
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