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.
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).
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).
Parallel
ERCP with suprapapillary stent placement
Procedure/SurgeryERCP with no sphincterotomy and placement of plastic stents above the papilla of Vater.
ERCP with transpapillary stent placement
Procedure/SurgeryStandard 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.
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.
Technical success
Defined as the placement of the stent(s) in the desired position (timepoint 0)
Clinical Success
Defined as the reduction of bilirubin level ≥50% or at a level \<2 mg/dL (34.2 mmol/L).
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