Preoperative biliary drainage in patients with Distal REsectAble and borderline resectable Malignant biliary obstruction by primary Endoscopic ultrasound guided choledochoduodenostomy versus Endoscopic retrograde cholangiopancreatography: a randomized controlled trial

Malignant distal biliary obstruction (MDBO) is a very common presentation among cases presenting with obstructive jaundice. But majority of the cases present in unresectable condition and surgery is possible only in a small precious cohort of 15-20%. For those cases undergoing surgery, pre-operative high bilirubin is a bad prognostic outcome. Among the choices of drainage, endoscopic therapy is preferred over percutaneous catheter drainage and among the stents used, fully covered self-expandable metal stents (SEMS) has shown to be superior to plastic stents owing to lower reintervention rates and higher patency. There are 2 strategies which can be adopted for biliary drainage: ERCP (endoscopic retrograde cholangiopancreatography) with biliary SEMS placement and EUS-CDS (endoscopic ultrasound guided choledochoduodenostomy) using LAMS (lumen apposing metal stent). This study has been planned as a multi-centre randomized controlled trial (RCT) to compare the 2 approaches (ERCP vs EUS-CDS) in patients with distal resectable and borderline resectable malignant biliary obstruction, as a primary drainage modality for pre-operative biliary drainage. It is a multi-centre RCT to be conducted at 4 academic tertiary care high volume centres.