EUS Biliary Drainage vs. ERCP

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

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.

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