Primary Percutaneous Stenting Above the Ampulla Versus Endoscopic Drainage for Unresectable Malignant Hilar Biliary Obstruction

Phase 3Enrolling By InvitationNCT06671418

Erasmus Medical Center148 enrolled

Overview

The goal of this clinical randomized controlled trial is to perform primary percutaneous stenting (PPS) in patients with malignant hilar biliary obstruction (MHBO). The main question it aims to answer is: To compare the efficacy of PPS above the ampulla to standard endoscopic biliary drainage (EBD) in patients with a MHBO who are ineligible for surgical resection. Researchers will compare PPS with EBD to see if major complications within 90 days after randomisation occur. Participants will undergo either primary percutaneous stenting or endoscopic biliary drainage, depending on randomization.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

148

Conditions

Cholangiocarcinoma Non-resectable Gall Bladder Cancer Liver Metastasis Malignant Hilar Stricture

Interventions

Primary percutaneous stenting (PPS)PROCEDURE

PPS bridging malignant hilar biliary obstruction with self-expandable uncovered metal stents without crossing the ampulla and without leaving an external drain. The procedure is performed by an interventional radiologist who has performed at least 5 PPS procedures.

Endoscopic biliary drainagePROCEDURE

EBD according to the American Society for Gastrointestinal Endoscopy (ASGE) guidelines of 2021. The procedure is performed by a gastro-enterologist who is experienced in performing EBD in patients with a MHBO.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Written informed consent must be given according to ICH/GCP and national/local regulations. * MHBO on imaging with histopathological confirmation or high clinical suspicion. * Ineligible for surgical resection. * Hyperbilirubinemia (a combination of a total bilirubin level \>50 mmol/l. Exclusion Criteria: * Fluctuation or spontaneous decrease of a total bilirubin level before start of any treatment suggesting a potential non-malignant diagnosis. * Patients who underwent previous biliary drainage procedures endoscopically or percutaneously. Patients who underwent an attempted but failed ERCP are eligible only when no papillotomy or cannulation was performed. * Clinical signs of cholangitis. Cholangitis is defined as the presence of both fever (i.e. body temperature \>38.5°C) and leucocytosis (i.e. ≥10 \*109/L) without clinical or radiological evidence of acute cholecystitis (22). * Uncorrectable coagulation disorder. * Uncorrectable contrast allergy.

Outcomes

Primary Outcomes

Major complications within 90 days after randomisation

The primary objective is to compare major complications within 90 days after randomization of PPS and EBD in patients with MHBO who are ineligible for surgical resection. Major complications are defined as any complication leading to prolonged hospital stay of more than 72 hours, readmission to hospital, invasive reintervention, or death.

Time frame: 90 days after randomization