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

January 3, 2026 updated by: Andrea Ruzzenente, Azienda Ospedaliera Universitaria Integrata Verona

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Radiological/ biochemical/pathological diagnosis of malignant OJ.
  2. Stenosis maximum extent may be 2 cm after biliary confluence.
  3. Documented obstructive jaundice (serum bilirubin > 3 mg/dL).
  4. Indication for biliary drainage (preoperative or palliative).
  5. Age ≥ 18 years.
  6. Signed informed consent.

Exclusion Criteria:

  1. Contraindications to endoscopic approach (duodenal stenosis, surgically altered anatomy).
  2. Previous sphincterotomy or drainage.
  3. Involvement of the papilla of Vater by the tumour.
  4. Uncontrolled coagulopathy (INR > 1.5 uncorrectable or <50.000 PLTs).
  5. Ongoing uncontrolled cholangitis as defined according to the Tokyo 2018 Guidelines, or systemic sepsis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Suprapapillary
ERCP for malignant stenosis of bile duct with suprapapillary stents positioning (experimental)
Procedure: ERCP with suprapapillary stent placement
ERCP with no sphincterotomy and placement of plastic stents above the papilla of Vater.
Active Comparator: Trans Papillary
ERCP for malignant stenosis of bile duct with transpapillary stents positioning (Standard of care).
Procedure: ERCP with transpapillary stent placement
Standard ERCP with or without sphincterotomy with trans papillary stent placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-to-Stent disfunction
Time Frame: From index procedure to a minimum of one year of follow up.

In days, calculated from the index procedure. Stent(s) dysfunction, which includes occlusion or migration of the stent(s) and tumour ingrowth/overgrowth, is defined as the presence of at least two of the following three criteria:

  1. New dilation of the biliary tree on imaging:
  2. Bilirubin level above 2 mg/dL (34.2 mmol/L) with a new increase ≥ 1 mg/dL compared with the value after initial clinical success, or elevation of alkaline phosphatase and/or g-glutamyl transferase greater than 2 times the upper normal limit with a new elevation of 30 U/L
  3. Cholangitis, characterized by fever along with leucocytosis (> 10,000/mL) or C-reactive protein levels above 20 mg/dL.
From index procedure to a minimum of one year of follow up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of the procedure
Time Frame: From the index procedure within 14 days.
The incidence of Adverse events and severe adverse events will be compared. Adverse events (AEs) (timepoint 14 days) are defined according to the ASGE lexicon and graded according to the Adverse Events in GI endoscopy (AGREE) classification that classifies AEs in 5 grades from Grade I, any deviation from standard postprocedural course without need for pharmacological or interventional treatment, to Grade V, death of the patient. Sub-group analysis will be performed for procedure-related AEs. Severe adverse events are defined as AGREE≥3.
From the index procedure within 14 days.
Technical success
Time Frame: At the moment of index procedure.
Defined as the placement of the stent(s) in the desired position (timepoint 0)
At the moment of index procedure.
Clinical Success
Time Frame: Between 14 and 30 days from the index procedure.
Defined as the reduction of bilirubin level ≥50% or at a level <2 mg/dL (34.2 mmol/L).
Between 14 and 30 days from the index procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Investigators

  • Principal Investigator: Andrea Ruzzenente, Professor, Integrated University Hospital Verona
  • Study Director: Stefano Francesco Crinò, Consultant, Integrated University Hospital Verona
  • Study Chair: Edoardo Poletto, PhD Candidate, Consultant, Integrated University Hospital Verona
  • Study Chair: Maria Cristina Conti Bellocchi, Consultant, Integrated University Hospital Verona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

December 16, 2025

First Submitted That Met QC Criteria

January 3, 2026

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 3, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID0001 (Other Identifier: Integrated University Hospital Verona)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Question asked to the ethics committee, decision is still pending.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Biliary Disease Tract

Clinical Trials on ERCP with suprapapillary stent placement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe