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

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

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

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.

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.