An interventional study of ERCP with suprapapillary stent placement and ERCP with transpapillary stent placement in Biliary Disease Tract, Biliary Stenosis and Biliary Stents, sponsored by Azienda Ospedaliera Universitaria Integrata Verona. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Azienda Ospedaliera Universitaria Integrata Verona · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
ERCP for malignant stenosis of bile duct with suprapapillary stents positioning (experimental)
Procedure: ERCP with suprapapillary stent placement
ERCP for malignant stenosis of bile duct with transpapillary stents positioning (Standard of care).
Procedure: ERCP with transpapillary stent placement
ERCP with no sphincterotomy and placement of plastic stents above the papilla of Vater.
Standard ERCP with or without sphincterotomy with trans papillary stent placement
Time-to-Stent disfunction
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.
Time frame: From index procedure to a minimum of one year of follow up.
Safety of the procedure
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.
Time frame: From the index procedure within 14 days.
Technical success
Defined as the placement of the stent(s) in the desired position (timepoint 0)
Time frame: At the moment of index procedure.
Clinical Success
Defined as the reduction of bilirubin level ≥50% or at a level \<2 mg/dL (34.2 mmol/L).
Time frame: Between 14 and 30 days from the index procedure.
No study locations are listed for this record.
Plan to share: Undecided — Question asked to the ethics committee, decision is still pending.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Azienda Ospedaliera Universitaria Integrata Verona