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

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.

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.