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Clinical Trials in France / NCT06768164
Recruiting Phase 3

Quality of Life After Billroth II or Roux-en-Y for Gastric Cancer

NCT06768164 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Phase 3
Started
2026-03-20
Last updated
2026-05-20

Condition(s) studied

Gastric (Cardia, Body) Cancer

Investigational drug(s) / intervention(s)

Billroth 2 (B2)Roux-En-Y (REY)

Billroth 2 (B2): B2 technique requires a single anastomosis (gastro-jejunostomy) after distal gastrectomy

Roux-En-Y (REY): REY technique requires 2 anastomoses (gastro-jejunostomy and entero-enterostomy) after distal gastrectomy

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • HRQol with 3 targeted dimensions — One year post-surgery
    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.

Trial sites (1)

FacilityCityRegionStatus
Hôpital Saint-Antoine Paris France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06768164 on ClinicalTrials.gov ↗ ← All trials in France