Clinical trial NCT06768164: Quality of Life After Billroth II or Roux-en-Y for Gastric Cancer
Official title: Health-Related Quality Of Life After Partial Gastrectomy for Gastric Cancer: Comparison of Reconstruction by Billroth II or Roux-en-Y. A Randomized, Comparative, Multicentric, Single-blinded Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Gastric (Cardia, Body) Cancer
Keywords: gastric cancer
gastrectomy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The realization of REY suggests an improvement of the HRQoL after distal gastric resection in comparison to the B2 anastomosis justifying the need of a RCT on the topic. Moreover, the REY could improve the gastro-intestinal symptoms and gastritis. The investigators hypothesize that the REY intervention after distal gastrectomy will improve HRQoL for 3 targeted dimensions of the EORTC QLQ-OG25 questionnaire (eating, reflux, pain and discomfort) in patients with gastric cancer.

All patients with a distal gastric cancer treated in curative intent by surgery with distal gastrectomy should be included. The choice of this population belongs in the fact that no reconstruction according billroth2 are performed for other gastric cancer requiring a total gastrectomy. Therefore, all patients treated by total gastrectomy need to be excluded. Secondly, the increase in survival of this population in the past decade araising to 75% at 5 years allows investigators to question the quality of life after surgery.

The anastomosis is realized with the proximal jejunum without entero-enterostomy in the first 70 cm after the angle of Treitz. The gastrojejunostomy could be ante-colic or trans-mesocolic. The anastomosis could be performed according the surgeon decision (mechanical or handsewn, isoperistaltic or anisoperistaltic).

The length of jejunum of the Y section needs to be at least 60 cm. The Roux-en-Y anastomosis could be antecolic or transmesocolic. The anastomosis could be realized according the surgeon decision (mechanical or handsewn, isoperistaltic or anisoperistaltic).

The choice between these two techniques will not add an increased risk to the patient since they are both recommended by national guidelines, they are both performed as standard care and there is no difference in Quality of Life at long term.

During surgery:

* A complete exploration of abdominal cavity is realized to avoid presence of peritoneal metastasis. This exploration is allowed by laparoscopy or open surgery
* The gastric tumor permits to realize R0 resection with 5 cm of resection margin according to the subtotal gastric resection on the line between the right side of gastro-esophageal junction and the end of the left gastro-omental artery
* In case of Linitis plastica, realization of anatomopathological examination of proximal margin without sign of tumoral involvement to access to randomization The type of surgery (B2 or REY) will be then determined by randomization

Interventions added for the research are:

* Randomization : the randomization will be realized by the investigator team
* One endoscopy at 1 year of follow-up after surgery
* Quality of Life questionnaires (EORTC QLQ-C30 and QLQ-OG25) at baseline, 3 months, 6 months, 1 year and 2 years of follow-up after surgery

Expected benefits for the participants: Improve HRQoL after distal gastrectomy. Patients will not be exposed to a specific risk as the two methods of reconstruction are described and used in the routine.

The design of the study (without excessive invasive exam) and the routine care monitoring associated to a better HRQoL evaluation compared to the "classic" post-operative follow-up of patient will help patient decision to participate to the study.

Eligibility criteria: 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

Primary outcomes:
measure: HRQol with 3 targeted dimensions
timeFrame: One year post-surgery
Secondary outcomes:
measure: Other EORTC QLQ-OG25 dimensions
timeFrame: Baseline, 3 months, 6 months, 1 year and 2 years post-surgery
measure: Other HRQoL dimensions
timeFrame: Baseline, 3 months, 6 months, 1 year and 2 years post-surgery
measure: Longitudinal changes of each HRQoL dimension
timeFrame: The long-term HRQoL (EORTC QLQ-OG25 questionnaire) after surgery for gastric cancer at 2 years
measure: Longitudinal changes of each HRQoL dimension
timeFrame: et The long-term HRQoL (EORTC QLQ-C30 questionnaire) after surgery for gastric cancer at 2 years
measure: The long-term HRQoL after surgery for gastric cancer at 2 years
timeFrame: 2 years post-surgery
measure: The long-term HRQoL after surgery for gastric cancer at 2 years
timeFrame: 2 years post-surgery
measure: The post-operative morbidity rates at 90 days
timeFrame: 90 days post-surgery
measure: The post-operative morbidity rates at 1 year
timeFrame: 1 year post-surgery
measure: The endoscopic biliary reflux rate and gastritis at 1 year post surgery
timeFrame: 1 year post-surgery
measure: The rate of proton pump inhibitor (PPI) use at 3 months, 6 months, 1 year and 2 years post-surgery
timeFrame: 3 months, 6 months, 1 year and 2 years post-surgery
measure: The survival at 1 year
timeFrame: 1 year post-surgery
measure: The survival at 2 years
timeFrame: 2 years post-surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Saint-Antoine
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Alexandre CHALLINE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: