Preventing gastric outlet obstruction in patients with advanced periampullary 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

This clinical trial investigates the effectiveness and safety of prophylactic EUS-guided gastroenterostomy (ProEUS-GE) in preventing malignant gastric outlet obstruction (MGOO) in patients diagnosed with advanced periampullary cancer. Participants will be randomly assigned to receive either ERCP alone or ERCP combined with ProEUS-GE. The study aims to determine if the addition of ProEUS-GE reduces the occurrence of MGOO compared to ERCP alone. The primary endpoint is the rate of gastric outlet obstruction, and the trial will be conducted at multiple centers with experienced endoscopists.

Why it matters

Who can join: the full rules

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

Where it's running

• McGill University Health Center
  Montreal, Canada Recruiting
• Jewish General Hospital
  Montreal, Canada Not yet recruiting
• St-Michael's Hospital (SMH)
  Toronto, Canada Not yet recruiting
• Hôpital Privé des Peupliers
  Paris, France Not yet recruiting
• Asian Institute of Gastroenterology
  Hyderabad, India Not yet recruiting

Study contacts

• Study coordinator: Yen-I Chen, MD
• Email: yen-i.chen@mgcill.com
• Phone: (514) 934-1934

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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.