Primary Percutaneous Stenting Above the Ampulla Versus Endoscopic Drainage for Unresectable Malignant Hilar Biliary Obstruction (TESLA RCT)
November 1, 2024 updated by: Bas Groot Koerkamp, MD, PhD, Erasmus Medical Center
Primary Percutaneous Stenting Above the Ampulla Versus Endoscopic Drainage for Unresectable Malignant Hilar Biliary Obstruction (TESLA RCT)
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 Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
148
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Rotterdam, Netherlands
- Erasmus MC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Endoscopic biliary drainage (standard of care)
|
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.
|
|
Active Comparator: Primary percutaneous stenting
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
90 days after randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 9, 2023
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2027
Study Registration Dates
First Submitted
November 1, 2024
First Submitted That Met QC Criteria
November 1, 2024
First Posted (Estimated)
November 4, 2024
Study Record Updates
Last Update Posted (Estimated)
November 4, 2024
Last Update Submitted That Met QC Criteria
November 1, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Erasmus MC TESLA RCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.