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

Recruiting now · Phase 3

Conditions studied: Gastric (Cardia, Body) Cancer

In brief

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.

Key facts

Study ID

NCT06768164

Run by

Assistance Publique - Hôpitaux de Paris

People needed

250

Starts

2026-03-20

Expected to finish

2031-04-01

Last updated by the study team

2026-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hôpital Saint-Antoine — Paris, France (enrolling)

Full record on ClinicalTrials.gov

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