Quality of life after Billroth II or Roux-en-Y for distal gastric cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In adults undergoing distal gastrectomy for gastric cancer, this randomized trial compares two reconstruction methods: Billroth II and Roux-en-Y. The study focuses on health-related quality of life, particularly eating, reflux, and pain symptoms, using the EORTC QLQ-OG25 questionnaire. Surgeons decide technical aspects such as anastomosis style and orientation, while patients are followed to assess QoL outcomes over time. Eligible participants are adults with distal gastric cancer treated curatively, fluent in French, and without metastatic disease. The trial aims to determine which reconstruction more favorably impacts postoperative QoL and related GI symptoms.

Why it matters

Who can join: the full rules

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

Where it's running

• Hôpital Saint-Antoine
  Paris, France Recruiting

Study contacts

• Principal investigator: Alexandre CHALLINE, MD, PhD — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Alexandre CHALLINE, MD, PhD
• Email: alexandre.challine@aphp.fr
• Phone: +33 1 49 28 25 33

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• How the CES1 liver enzyme affects capecitabine levels in people with colorectal, gastric, or esophageal cancer

  This project will see if differences in the CES1 enzyme change how capecitabine is processed and whether that affects side effects like hand‑foot syndrome in adults starting capecitabine with oxaliplatin for colorectal, gastric, or esophageal cancer.

  Recruiting Erasmus Medical Center · Rotterdam · NCT07114627

• Best time for minimally invasive local treatment after first-line systemic therapy for limited (oligo) esophageal or stomach cancer

  This trial will test whether giving local treatment (surgery or radiation) earlier or later after first-line systemic therapy works better for people whose esophageal or stomach cancer has spread to only a few sites.

  Recruiting at 4 sites Phase 2 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Amsterdam and 4 other locations · NCT07000253

• Evaluating pain management methods for minimally invasive cancer surgery

  This study is testing which pain management method works best for people undergoing minimally invasive cancer surgery by comparing three different approaches.

  Recruiting Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Pittsburgh, Pennsylvania · NCT06731998

• Examining the relationship between Sintilimab levels and treatment outcomes in advanced gastric cancer patients

  This study is testing how the levels of Sintilimab in the blood affect treatment results and side effects for people with advanced gastric cancer.

  Recruiting Zhongda Hospital · Nanjing, Jiangsu · NCT06702683

• Total neoadjuvant chemotherapy for advanced gastric and gastroesophageal cancer

  This study is testing two different chemotherapy plans for people with advanced stomach cancer to see which one helps them better tolerate treatment and successfully have surgery.

  Recruiting at 2 sites Phase 2/3 Ukrainian Society of Clinical Oncology · Vilnius and 1 other locations · NCT06028737

• Analysis of exosomes and single-cell data in gastric cardia cancer

  This study is trying to find new ways to diagnose and treat gastric cardia cancer by looking at biological samples from patients and comparing them to healthy controls.

  Recruiting Qilu Hospital of Shandong University · Jinan, Shandong · NCT06702891

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.