Status:
COMPLETED
EUS Biliary Drainage vs. ERCP
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Biliary Obstruction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Endoscopic ultrasound guided biliary drainage (EUS-BD) is an evolving field that has grown in popularity in the management of malignant biliary obstruction. Although Endoscopic retrograde cholangio-pa...
Eligibility Criteria
Inclusion
- Radiological diagnosis (with or without pathological diagnosis) of borderline resectable, locally advanced, or unresectable malignant distal biliary obstruction at least 2 cm distal to the hilum. Resectability based on tumor staging on axial imaging and surgeon evaluation.
- Elevated liver tests with serum bilirubin at least 3 times above the upper limit of normal (18.9 umol/L)
- Dilated extra-hepatic bile duct measuring at least 1.2 cm on axial imaging or US
- Confirmation of bile duct accessibility and size of at least 1.2 cm on endoscopic ultrasound
- Karnofsky index \> 30%
- ASA score \<IV
- Provision of informed consent
Exclusion
- Hilar obstruction (biliary obstruction \< 2 cm from the hilum)
- Uncorrectable coagulopathy and/or thrombocytopenia
- Age \< 18
- Liver metastasis involving \> 30% of the liver volume
- Liver cirrhosis with portal hypertension or ascites
- Prior biliary sphincterotomy or stent placement
- Surgically altered anatomy
- Common bile duct measuring less than 1.2 cm will be excluded
- Patient with clinical and radiological evidence of gastric outlet obstruction
Key Trial Info
Start Date :
March 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT03870386
Start Date
March 8 2019
End Date
July 1 2023
Last Update
August 14 2023
Active Locations (11)
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1
University of Calgary
Calgary, Alberta, Canada
2
University of Alberta
Edmonton, Alberta, Canada
3
Vancouver General Hospital
Vancouver, Bristish Columbia, Canada
4
St-Paul Hospital
Vancouver, British Columbia, Canada