NCT07325877

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

Supra-papillary Versus Trans-papillary Biliary Stenting in Malignant Peri-hilar Stenosis (SupraBilS): a Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Biliary Disease Tract
• Biliary Stenosis
• Biliary Stents

Interventions

Type	Name	Description
PROCEDURE	ERCP with suprapapillary stent placement	ERCP with no sphincterotomy and placement of plastic stents above the papilla of Vater.
PROCEDURE	ERCP with transpapillary stent placement	Standard ERCP with or without sphincterotomy with trans papillary stent placement

Timeline

• Start date: 2026-03-01
• Primary completion: 2029-03-01
• Completion: 2029-03-01
• First posted: 2026-01-08
• Last updated: 2026-01-08