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

RecruitingPhase 3Ages 18 Years - anyAllAssistance Publique - Hôpitaux de Paris
NCT06768164 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

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

1 site
Hôpital Saint-Antoine
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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