CompletedNot Applicable

EUS Biliary Drainage vs. ERCP

Canada144 participantsStarted 2019-03-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Rate of re-intervention

Timeframe: 1 year

Trial details

NCT IDNCT03870386

SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-01