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
Parallel
Modified 8-mm Fully Covered Self-Expandable Metal Stent
DeviceA modified non-flared 8-mm fully covered self-expandable metal stent designed for preoperative biliary drainage. The stent features a dumbbell-shaped structure with a narrower central portion to reduce migration, a fully covered membrane to prevent tissue ingrowth, and a retrieval lasso to facilitate removal. It is deployed via ERCP across the malignant biliary stricture.
Plastic stent
DeviceA conventional 8.5-Fr plastic biliary stent used for preoperative biliary drainage. The stent is placed via ERCP across the malignant biliary stricture and represents the standard treatment option, although it is associated with shorter patency and a higher risk of occlusion compared to metal stents.
Stent-Related Non-Event Rate at Surgery
The proportion of patients who do not require reintervention due to stent-related complications from stent placement until the time of surgery.
Recurrent Biliary Obstruction Rate
The proportion of patients who develop recurrent biliary obstruction requiring reintervention
Time to Recurrent Biliary Obstruction
Time from stent placement to the occurrence of recurrent biliary obstruction
Stent-Related Adverse Events
Incidence of adverse events related to stent placement, including pancreatitis, cholangitis, cholecystitis, bleeding, perforation, or stent migration
Technical Success Rate
Successful placement of the stent across the target biliary stricture in the intended position
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Soonchunhyang University Hospital
Lead sponsor
Soonchunhyang University School of Medicine
Sponsor institution
Samsung Medical Center
Collaborator
Asan Medical Center
Collaborator
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