EUS Biliary Drainage vs. ERCP
- Conditions
- Biliary Obstruction
- Registration Number
- NCT03870386
- Lead Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- 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-pancreatography (ERCP) with stent insertion has been the mainstay therapy throughout several decades, the transpapillary approach through tumor tissue is associated with significant risk for adverse events such as post-ERCP pancreatitis and stent dysfunction from tumor tissue overgrowth and ingrowth. EUS-BD, through the creation of a choledochoduodenostomy with a stent, has the potential advantage of avoiding the papilla and its associated complications while potentially improving stent patency with lower risks for tumor tissue ingrowth and/or overgrowth.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 144
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Rate of re-intervention 1 year Obstruction and/or migration of stent
- Secondary Outcome Measures
Name Time Method Stent patency 1 year mean time to stent obstruction or migration
Clinical success 1 year 50% decrease in bilirubin \< 2 weeks post-stent insertion or less than 25% of pre-procedure bilirubin level within 4 weeks post stent insertion
Technical success 1 year successful insertion of a transpapillary stent or choledochoduodenostomy stent at the initial procedure at time of randomization
Early adverse events 1 year as per the ASGE lexicon for endoscopic adverse events13 including post-procedural pancreatitis defined as new or worsening abdominal pain persistent for at least 24 hours and requiring analgesics after ERCP or EUS-BD with an elevated amylase or lipase of greater than three times the upper limit of normal, peri-procedural bleeding defined as hematemesis and/or melena or hemoglobin drop \> 2 g, intestinal perforation defined as evidence of air or luminal contents outside the GI tract, and cholangitis \>38 Celsius for greater than 24 hours with cholestatic liver enzymes
Trial Locations
- Locations (11)
University of Calgary
🇨🇦Calgary, Alberta, Canada
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Vancouver General Hospital
🇨🇦Vancouver, Bristish Columbia, Canada
St-Paul Hospital
🇨🇦Vancouver, British Columbia, Canada
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
St-Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Centre Hospitalier Universite de Montreal
🇨🇦Montréal, Quebec, Canada
McGill University Health Centre
🇨🇦Montréal, Quebec, Canada
Hopital Charles Lemoynes
🇨🇦Montréal, Quebec, Canada
Jewish General Hospital
🇨🇦Montreal, Canada
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