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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Cholangiocarcinoma Non-resectable Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Gall Bladder Cancer Gallbladder Diseases Gallbladder Neoplasms Liver Metastasis Malignant Hilar Stricture Neoplasms Neoplasms by Site

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Erasmus MC

Rotterdam, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 drainage

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 outcomes

Major complications within 90 days after randomisation

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

Dutch Cancer Society

Registry information

Official study title

Primary Percutaneous Stenting Above the Ampulla Versus Endoscopic Drainage for Unresectable Malignant Hilar Biliary Obstruction (TESLA RCT)

Acronym: TESLA RCT

Important dates

Study start: 2023
Primary completion: 2027
Study completion: 2027
First posted: Nov 4, 2024
Registry last updated: Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting