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Suprapapillary Versus Transpapillary Plastic Stents for Unresectable Malignant Hilar Biliary Obstruction

StatusNot Yet Recruiting
PhaseNot applicable
Started2026-09-01
View on ClinicalTrials.gov ↗
Bile duct blockage caused by cancer near the liver hilum (where the bile ducts join) leads to jaundice and infection. The standard treatment is to place a plastic stent (a small tube) through an endoscope to drain the bile. Conventionally, the stent is placed across the papilla, the opening between the bile duct and the intestine, with one end inside the intestine. An alternative method places the stent entirely inside the bile duct, above the papilla, which may reduce bacterial contamination from the intestine and help the stent stay open longer. However, previous studies have shown inconsistent results. This multicenter randomized trial will compare these two stent placement methods in patients with unresectable malignant hilar biliary obstruction. About 70 participants will be randomly assigned (50:50) to receive either a suprapapillary (above the papilla) or a transpapillary (across the papilla) plastic stent during the same standard endoscopic procedure (ERCP). Both stents are approved, commonly used medical devices. The main question is which method keeps the bile duct open longer before re-blockage. Participants will be followed with regular clinic visits, and safety will be monitored throughout the study.
Trial Details
NCT Number NCT07811791
Lead Sponsor National Taiwan University Hospital
Conditions Biliary Tract Neoplasms, Biliary Drainage, Malignant Biliary Obstruction, Obstructive Jaundice
Enrollment 70 participants
Start Date 2026-09-01
Primary Completion 2028-03-30 (estimated)
Study Completion 2029-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-09-10