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NCT Number: NCT07325877

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

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.

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Key information

Conditions

Biliary Disease Tract Biliary Stenosis Biliary Stents Biliary Tract Diseases Digestive System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

ERCP with suprapapillary stent placement

Procedure

ERCP with no sphincterotomy and placement of plastic stents above the papilla of Vater.

ERCP with transpapillary stent placement

Procedure

Standard ERCP with or without sphincterotomy with trans papillary stent placement

Primary outcomes

  1. 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:

    • New dilation of the biliary tree on imaging:
    • 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
    • Cholangitis, characterized by fever along with leucocytosis (> 10,000/mL) or C-reactive protein levels above 20 mg/dL.

Secondary outcomes

  1. 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.

  2. Technical success

    Time frame: At the moment of index procedure.

    Defined as the placement of the stent(s) in the desired position (timepoint 0)

  3. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Ruzzenente, Professor

CONTACT

[email protected]

+39 0458124644

Edoardo Poletto, PhD Candidate - Consultant

CONTACT

[email protected]

+39 3452308635

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Other

Registry information

Official study title

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

Acronym: SupraBilS

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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