Lumen apposing metal stents versus Covered tubular self-expanding metal stents for EUS-guided choledochoduodenostomy In Distal malignant biliary obstruction: A randomized controlled trial

The gold standard for the management of malignant distal biliary obstruction (MDBO) has been endoscopic retrograde cholangiopancreatography (ERCP). Despite the advancements in endoscopic accessories and techniques, failure to cannulate may be present in 4-16% cases. In such cases, patients are salvaged with percutaneous transhepatic biliary drainage (PTBD) or surgery. Both salvage modalities have their own shortcomings. An alternative to these which has gained momentum in MBO management has been endoscopic ultrasound guided biliary drainage (EUS-BD). For MDBO, EUS-guided choledochoduodenostomy (EUS-CDS) or EUS-guided hepaticogastrostomy can be done. For EUS-CDS, it is more technically easier and can be done by either tubular metal stents (SEMS) or cautery enhanced lumen apposing metal stents (EC-LAMS). Both these stents has their own set of pros and cons. But which metal stent to prefer (SEMS versus EC-LAMS) for EUS-CDS is still debatable. We hypothesized that, while EC-LAMS and SEMS would be equally effective and safe, the rates of stent dysfunction/block requiring re-intervention would be different between the two arms considering the inherent difference in the design of the two stents. Thus, this study has been planned to compare EC-LAMS versus covered tubular SEMS in EUS-CDS in terms of clinical efficacy, safety, and re-intervention rates.