Clinical Trial

Supra-papillary Versus Trans-papillary Biliary Stenting in Malignant Peri-hilar Stenosis

Study acronym: SupraBilS
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07325877
Lead Sponsor Azienda Ospedaliera Universitaria Integrata Verona
Conditions Biliary Disease Tract, Biliary Stenosis, Biliary Stents
Enrollment 70 participants
Start Date 2026-03-01
Primary Completion 2029-03-01 (estimated)
Study Completion 2029-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-08