Comparison of a Short Modified Metal Stent Versus Plastic Stent as a Bridge to Surgery in Pancreatic Cancer With Malignant Biliary Obstruction
Starting soon · Not applicable
Conditions studied: Pancreatic Cancer, Malignant Biliary Obstruction
In brief
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.
Key facts
- Study ID
- NCT07606430
- Run by
- Soonchunhyang University Hospital
- People needed
- 116
- Starts
- 2026-05-01
- Expected to finish
- 2029-12-31
- Last updated by the study team
- 2026-05-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Ability to provide written informed consent
You may not qualify if…
- 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
- Inability to undergo ERCP
- Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study outcomes
Full record on ClinicalTrials.gov
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