EUS-guided Biliary Drainage of First Intent With the Lumen Apposing Metal Stent vs. ERCP in the Management of Malignant Distal Biliary Obstruction: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Biliary Obstruction
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Enrollment
- 144
- Locations
- 11
- Primary Endpoint
- Rate of re-intervention
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Yen-I Chen
Primary Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Rate of re-intervention
Time Frame: 1 year
Obstruction and/or migration of stent
Secondary Outcomes
- Stent patency(1 year)
- Clinical success(1 year)
- Technical success(1 year)
- Early adverse events(1 year)