This study is a multicenter, randomized clinical trial designed to compare the effectiveness and safety of a modified 8-mm fully covered self-expandable metal stent (FCSEMS) with a conventional plastic stent for preoperative biliary drainage in patients with pancreatic cancer and malignant biliary obstruction.
In patients who require biliary drainage before surgery, stent placement is commonly performed using endoscopic retrograde cholangiopancreatography (ERCP). However, the optimal stent type remains uncertain.
Participants will be randomly assigned to receive either the modified FCSEMS or a plastic stent. The primary objective is to evaluate the rate of stent-related complications requiring reintervention before surgery. Secondary outcomes include stent patency, adverse events, and surgical outcomes.
The results of this study are expected to help determine the most appropriate stent strategy for patients undergoing surgery for pancreatic cancer.
Age ≥ 18 years
Patients with resectable, borderline resectable, or locally advanced pancreatic cancer with distal malignant biliary obstruction requiring endoscopic biliary drainage
Biliary stricture located ≥ 2 cm below the hepatic hilum
Serum bilirubin ≥ 3 mg/dL
Presence of distant metastasis
Prior biliary stent placement for biliary obstruction
Requirement for duodenal stent placement due to gastric outlet obstruction
Estimated life expectancy < 3 months
Soonchunhyang University Hospital
Lead sponsor
Soonchunhyang University School of Medicine
Sponsor institution
Samsung Medical Center
Collaborator
Asan Medical Center
Collaborator