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

NCT06768164 | Not Yet Recruiting Phase 3

• 2 other identifiers: APHP2103552022-A00730-43
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric (Cardia, Body) Cancer

Keywords

gastric cancer; gastrectomy

Outcome Measures

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.

  One year post-surgery

Secondary Outcomes (12)

• Other EORTC QLQ-OG25 dimensions

  Baseline, 3 months, 6 months, 1 year and 2 years post-surgery

• Other HRQoL dimensions

  Baseline, 3 months, 6 months, 1 year and 2 years post-surgery

• Longitudinal changes of each HRQoL dimension

  The long-term HRQoL (EORTC QLQ-OG25 questionnaire) after surgery for gastric cancer at 2 years

• Longitudinal changes of each HRQoL dimension

  et The long-term HRQoL (EORTC QLQ-C30 questionnaire) after surgery for gastric cancer at 2 years

• The long-term HRQoL after surgery for gastric cancer at 2 years

  2 years post-surgery

Study Arms (2)

Billroth 2 (B2)

EXPERIMENTAL

Procedure: Billroth 2 (B2)

Roux-En-Y (REY)

EXPERIMENTAL

Procedure: Roux-En-Y (REY)

Interventions

Billroth 2 (B2) PROCEDURE

B2 technique requires a single anastomosis (gastro-jejunostomy) after distal gastrectomy

Billroth 2 (B2)

Roux-En-Y (REY) PROCEDURE

REY technique requires 2 anastomoses (gastro-jejunostomy and entero-enterostomy) after distal gastrectomy

Roux-En-Y (REY)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Saint-Antoine

Paris, 75012, France

Location

MeSH Terms

Conditions

Neoplasms; Stomach Neoplasms

Interventions

Anastomosis, Roux-en-Y

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Alexandre CHALLINE, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre CHALLINE, MD, PhD

CONTACT

+33 1 49 28 25 33; alexandre.challine@aphp.fr

Christelle AUGER

CONTACT

+33 1 58 41 11 86; christelle.auger@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: January 10, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

FR (1)