Prophylactic endoscopic transpapillary gallbladder stenting at fully covered self-expandable metal stent placement to prevent cholecystitis in malignant distal biliary obstruction: A multicenter prospective single-arm study protocol (PROTECT study)

Background

Malignant distal biliary obstruction (MDBO) is commonly managed with endoscopic retrograde cholangiopancreatography (ERCP)-guided transpapillary stenting. Fully covered self-expandable metal stents (FCSEMSs) provide durable biliary drainage but may increase the risk of acute cholecystitis due to cystic duct obstruction. Prophylactic endoscopic transpapillary gallbladder stenting (ETGBS) at the time of FCSEMS placement has been proposed to reduce the risk of cholecystitis after FCSEMS placement. However, the available evidence is limited. This study aims to explore the potential clinical benefit of attempting prophylactic ETGBS by estimating the incidence of acute cholecystitis after FCSEMS placement and characterizing the technical feasibility and safety of the strategy in patients with MDBO.