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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Billroth 2 (B2)
Procedure/SurgeryB2 technique requires a single anastomosis (gastro-jejunostomy) after distal gastrectomy
Roux-En-Y (REY)
Procedure/SurgeryREY technique requires 2 anastomoses (gastro-jejunostomy and entero-enterostomy) after distal gastrectomy
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Billroth 2 (B2)Experimental treatment 1 intervention
Group B: Roux-En-Y (REY)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
HRQol with 3 targeted dimensions
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.
Time frame
One year post-surgerySecondary outcomes
1
Other EORTC QLQ-OG25 dimensions
Other dimensions of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, OesophagoGastric 25 (EORTC QLQ-OG25) questionnaire : * Dysphagia : \[0-100\]. * Odynophagia : \[0-100\]. * Anxiety : \[0-100\]. If high scores = more problems.
Time frame
Baseline, 3 months, 6 months, 1 year and 2 years post-surgery2
Other HRQoL dimensions
Other dimensions of the HRQoL measured with the EORTC QLQ-C30 ( European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaires, Core 30) questionnaire will be described at baseline, 3 months, 6 months, 1 year and 2 years post-surgery : * Physical function : \[0-100\]. * Role function : \[0-100\]. * Emotional function : \[0-100\]. * Cognitive function : \[0-100\]. * Social function : \[0-100\]. * Overall quality of life : \[0-100\]. For these dimensions above if high score = better function. * Pain : \[0-100\]. * Fatigue : \[0-100\]. * Nausea and vomiting : \[0-100\]. For these dimensions above if high score = more problems.
Time frame
Baseline, 3 months, 6 months, 1 year and 2 years post-surgery3
Longitudinal changes of each HRQoL dimension
\- The long-term HRQoL after surgery for gastric cancer at 2 years
Time frame
The long-term HRQoL (EORTC QLQ-OG25 questionnaire) after surgery for gastric cancer at 2 years4
Longitudinal changes of each HRQoL dimension
The long-Term HRQoL after surgery for gastric cancer at 2 years
Time frame
et The long-term HRQoL (EORTC QLQ-C30 questionnaire) after surgery for gastric cancer at 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Assistance Publique - Hôpitaux de Paris
Lead sponsor
URC-CIC Paris Descartes Necker Cochin
Collaborator
Source ClinicalTrials.gov