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 groupsSponsors and collaborators
Assistance Publique - Hôpitaux de Paris
Lead sponsor
URC-CIC Paris Descartes Necker Cochin
Collaborator
Source ClinicalTrials.gov