🏛️ Verified NIH Record • Updated 2024-09-27

Prophylactic EUS-guided Gastroenterostomy in Advanced Periampullary Cancers (NCT05994521)

🟢 Recruiting Observational / Diagnostic 🩺 Clinical Procedure Protocol Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

🩺 Plain-English Summary (8th-Grade Level)

The goal of this randomized controlled trial is to investigate the effectiveness and safety of Prophylactic EUS-gastroenterostomy (ProEUS-GE) as a preventative approach for malignant gastric outlet obstruction (MGOO) in men and women aged 18 years or older diagnosed with periampullary cancer. The main question this study aims to answer is can ProEUS-GE effectively prevent the occurrence of MGOO in patients with periampullary cancer? Patients will be randomly assigned to one of two groups: Group 1 (ERCP alone) or Group 2 (ERCP + ProEUS-GE). The study will compare the outcomes between these groups to determine the effectiveness of ProEUS-GE in preventing MGOO. Researchers will compare Group 1 (ERCP alone) with Group 2 (ERCP + ProEUS-GE) to see if the addition of ProEUS-GE leads to a reduced occurrence of MGOO in patients with periampullary cancer. The primary endpoint is the rate of malignant gastric outlet obstruction.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (9 items).

Location: Jewish General Hospital — Montreal

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria (any of the following):
  • Patient with clinical and radiological evidence of malignant gastric outlet obstruction defined as Gastric Outlet Obstruction Scoring System (GOOSS) of \< 3 with radiological and/or endoscopic evidence of a mechanical obstruction from a gastric or duodenal stricture. GOOSS is a validated tool for assessing MGOO and is scored based on the diet tolerated by the patient: 0 for no oral intake, 1 for liquids only, 2 for soft diet, and 3 for low residue or full diet.
  • Gastroparesis with a Gastroparesis Cardinal Symptom Index (GCSI) of \>2. Gastroparesis is defined as having symptoms of MGOO without radiological and/or endoscopic evidence of mechanical obstruction.
  • Uncorrectable coagulopathy and/or thrombocytopenia
  • Age \< 18 or ≥ 85
  • Evidence of peritoneal carcinomatosisAscites
  • Liver metastasis \> 30% of the liver volume
  • Portal hypertension with gastroesophageal varices and/or ascites
  • Surgically altered upper gastrointestinal anatomy

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (5 Sites)

  • Jewish General Hospital — Montreal,
  • McGill University Health Center — Montreal,
  • St-Michael's Hospital (SMH) — Toronto,
  • Hôpital Privé des Peupliers — Paris,
  • Asian Institute of Gastroenterology — Hyderabad,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗