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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE3

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-09

Study Completion Date

2027-11-01

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endoscopic biliary drainage (standard of care)

Group Type OTHER

Endoscopic biliary drainage

Intervention Type PROCEDURE

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.

Primary percutaneous stenting

Group Type ACTIVE_COMPARATOR

Primary percutaneous stenting (PPS)

Intervention Type 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.

Interventions

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Primary percutaneous stenting (PPS)

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.

Intervention Type PROCEDURE

Endoscopic biliary drainage

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No