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

Phase 3

• Conditions: Cholangiocarcinoma Non-resectable; Gall Bladder Cancer; Liver Metastasis; Malignant Hilar Stricture

• Registration Number: NCT06671418
• Lead Sponsor: Erasmus Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-09
• Status Verified: 2024-10
• Study First Submitted: 2024-11-01
• Study First Submitted QC: 2024-11-01
• Last Update Submitted: 2024-11-01
• Study First Posted: 2024-11-04
• Last Update Posted: 2024-11-04
• Primary Completion: 2027-11-01
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 148

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Major complications within 90 days after randomisation	90 days after randomization	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.

Trial Locations

Locations (1)

Erasmus MC; 🇳🇱 Rotterdam, Netherlands