Health Trials

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

ConditionGastric (Cardia, Body) Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

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

Treatment groups

250 Participants
are divided into 2 treatment groups

Locations

1
Hôpital Saint-Antoine75012, Paris France

Sponsors and collaborators

Assistance Publique - Hôpitaux de Paris

Lead sponsor

URC-CIC Paris Descartes Necker Cochin

Collaborator

Source ClinicalTrials.gov