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

N/ANot Yet RecruitingNCT07325877

Azienda Ospedaliera Universitaria Integrata Verona70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Biliary Disease Tract Biliary Stenosis Biliary Stents

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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.