Status:
RECRUITING
Prophylactic EUS-guided Gastroenterostomy in Advanced Periampullary Cancers
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsors:
Jewish General Hospital
Unity Health Toronto
Conditions:
Cancer Gi
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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 ob...
Detailed Description
Research Question: The principal research question is whether ProEUS-GE can prevent the occurrence of MGOO in patients with pancreatic head cancer. We hypothesize that the addition of ProEUS-GE durin...
Eligibility Criteria
Inclusion
- Inclusion Criteria (all of the following):
- 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.
- Elevated liver function tests requiring ERCP without evidence of MGOO of significant gastroparesis (see exclusion criterion #3 and #4)
- ECOG 0 or 1
- ASA\<4
- Provision of informed consent
- 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
Exclusion
Key Trial Info
Start Date :
April 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT05994521
Start Date
April 9 2024
End Date
August 1 2027
Last Update
October 1 2024
Active Locations (5)
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1
Jewish General Hospital
Montreal, Canada
2
McGill University Health Center
Montreal, Canada
3
St-Michael's Hospital (SMH)
Toronto, Canada
4
Hôpital Privé des Peupliers
Paris, France