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Supra-papillary Versus Trans-papillary Biliary Stenting in Malignant Peri-hilar Stenosis
Sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Summary
This is a randomized controlled trial comparing patients with obstructive jaundice due to malignancies of the perihilar area of bile ducts and undergoing both preoperative and palliative biliary drainage. The comparison will focus on the technique:, on the one hand, an arm of patients undergoing standard-of-care ERCP with trans-papillary plastic protesis placement, and on the other hand, an experimental arm of patients undergoing suprapapillary plastic protesis placement with no sphincterotomy. The primary objective will be to compare the time-to-stent dysfunction in the two groups; secondary objectives will include a comparison of the safety, technical, and clinical success of the procedures.
Official title: Supra-papillary Versus Trans-papillary Biliary Stenting in Malignant Peri-hilar Stenosis (SupraBilS): a Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2026-03-01
Completion Date
2029-03-01
Last Updated
2026-01-08
Healthy Volunteers
No
Interventions
ERCP with suprapapillary stent placement
ERCP with no sphincterotomy and placement of plastic stents above the papilla of Vater.
ERCP with transpapillary stent placement
Standard ERCP with or without sphincterotomy with trans papillary stent placement