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

NCT07325877 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-01-08

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Azienda Ospedaliera Universitaria Integrata Verona

    lead OTHER

Principal Investigators

  • Andrea Ruzzenente, Professor · Integrated University Hospital Verona

  • Stefano Francesco Crinò, Consultant · Integrated University Hospital Verona

  • Edoardo Poletto, PhD Candidate, Consultant · Integrated university Hospital Verona

  • Maria Cristina Conti Bellocchi, Consultant · Integrated University Hospital Verona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2029-03-01
Completion
2029-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07325877 on ClinicalTrials.gov