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Suprapapillary Versus Transpapillary Plastic Stents for Unresectable Malignant Hilar Biliary Obstruction
Sponsor: National Taiwan University Hospital
Summary
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.
Official title: Suprapapillary Versus Transpapillary Biliary Plastic Stents for Unresectable High-grade Malignant Hilar Biliary Obstruction
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2026-09-01
Completion Date
2029-02-28
Last Updated
2026-09-10
Healthy Volunteers
No
Interventions
Suprapapillary plastic stent placement
Endoscopic retrograde cholangiopancreatography (ERCP) with placement of a plastic biliary stent entirely above the papilla (suprapapillary/inside stent). The distal end of the stent remains within the
Transpapillary plastic stent placement
Endoscopic retrograde cholangiopancreatography (ERCP) with placement of a conventional plastic biliary stent across the papilla, with the distal end positioned within the duodenal lumen. Commercially available, regulatory-approved plastic biliary stents are used; stent size and number are determined by the endoscopist according to the stricture anatomy.
Locations (8)
National Taiwan University Hospital Hsinchu Branch, Biomedical Park Hospital
Hsinchu, Taiwan
Taipei Tzu Chi Hospital
New Taipei City, Taiwan
Chung Shan Medical University Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Cancer Center
Taipei, Taiwan
National Taiwan University Hospital (Coordinating Center)
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan