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Prophylactic EUS-guided Gastroenterostomy in Advanced Periampullary Cancers

RecruitingNAAges 18 Years - 85 YearsAllMcGill University Health Centre/Research Institut…
NCT05994521 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ma

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📋 Eligibility rules (as published)
Inclusion Criteria (all of the following): 1. Radiological diagnosis of a periampullary cancer that is precluded from upfront surgical resection of curative intent due to advanced tumor stage. These include locally advanced or metastatic cancers of the pancreatic head, distal bile duct, duodenum, or ampulla. cancers. 2. Elevated liver function tests requiring ERCP without evidence of MGOO of significant gastroparesis (see exclusion criterion #3 and #4) 3. ECOG 0 or 1 4. ASA\<4 5. Provision of informed consent Exclusion Criteria (any of the following): 1. 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. 2. 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. 3. Uncorrectable coagulopathy and/or thrombocytopenia 4. Age \< 18 or ≥ 85 5. Evidence of peritoneal carcinomatosisAscites 6. Liver metastasis \> 30% of the liver volume 7. Portal hypertension with gastroesophageal varices and/or ascites 8. Surgically altered upper gastrointestinal anatomy
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What it tests

  • ERCP alone
  • ERCP +ProEUS-GE
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Where

5 sites
Jewish General Hospital
Montreal, Canada
McGill University Health Center
Montreal, Canada
St-Michael's Hospital (SMH)
Toronto, Canada
Hôpital Privé des Peupliers
Paris, France
Asian Institute of Gastroenterology
Hyderabad, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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