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

Integrated University Hospital Trust of Verona

Status: Begins enrollment this month

Conditions: Biliary Stenosis; Biliary Disease Tract; Biliary Stents

Treatments: Procedure: ERCP with transpapillary stent placement; Procedure: ERCP with suprapapillary stent placement

Study type: Interventional

Funder types: Other

Identifiers

NCT07325877

ID0001

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Suprapapillary

Experimental group

Description:

ERCP for malignant stenosis of bile duct with suprapapillary stents positioning (experimental)

Treatment:

Procedure: ERCP with suprapapillary stent placement

Trans Papillary

Active Comparator group

Description:

ERCP for malignant stenosis of bile duct with transpapillary stents positioning (Standard of care).

Treatment:

Procedure: ERCP with transpapillary stent placement