Actively Recruiting
Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma: a Randomized Controlled Trial
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2026-05-26
122
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead Sponsor
E
Erasmus Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to compare two approaches for treating malignant biliary obstruction caused by inoperable perihilar cholangiocarcinoma, a type of bile duct cancer. It is a multicenter, randomized controlled trial evaluating the use of endobiliary radiofrequency ablation (eRFA) before placing a metal stent versus stent placement alone. The study is sponsored by the Academisch Medisch Centrum - Universiteit van Amsterdam and focuses on patients who cannot undergo surgery due to advanced disease. Participants will be randomly assigned to receive either the experimental treatment of eRFA followed by placement of an uncovered self-expanding metal stent (uSEMS) or the active comparator treatment of stent placement only. The eRFA involves using a device to apply radiofrequency energy inside the bile duct to ablate tumor tissue before placing the stent. The stent helps keep the bile duct open to relieve obstruction. The study treatment is delivered during endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) as appropriate. Throughout the study, participants will be monitored for up to one year to assess the time until biliary obstruction recurs, quality of life, technical and functional success of the interventions, reasons for obstruction, need for additional drainage procedures, stent patency, adverse events within 30 days, overall survival, and healthcare costs. Follow-up includes clinical evaluations, imaging, and record of any re-interventions. The trial aims to provide comprehensive information on how these treatments compare in managing this challenging condition.
CONDITIONS
Brief Title
Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Able to provide written and oral informed consent
- Histological or cytological confirmation of perihilar cholangiocarcinoma (adenocarcinoma)
- Presence of perihilar biliary obstruction requiring drainage with an uncovered self-expanding metal stent
- Advanced disease not eligible for surgical removal due to metastases or vascular/lymph node involvement as determined by multidisciplinary team
- Patients with possible intrahepatic cholangiocarcinoma with perihilar obstruction may be included if reasonably uncertain
You will not qualify if you...
- Potential candidates for curative surgical resection of perihilar cholangiocarcinoma
- Eligible for liver transplantation
- Life expectancy less than 3 months
- Technical infeasibility of ERCP or percutaneous transhepatic cholangiography
- Uncontrolled bleeding disorders (prolonged PTT or low platelets)
- Ongoing infections such as cholangitis or liver abscess; must be off antibiotics for at least 7 days
- Any unstable condition risking safety or study compliance
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure
Participants undergo intraductal radiofrequency ablation of tumor prior to stent placement or receive uncovered self-expanding metal stent placement only.
1 procedure visit (in-person)
Duration - Up to 1 year
Participants are monitored for technical and functional success, adverse events, and need for re-intervention through study completion up to 1 year.
Regular visits for monitoring through 1 year
Trial Site Locations
Total: 1 location
1
Amsterdam UMC location VUmc
Amsterdam, Netherlands, 1081HV
Actively Recruiting
Research Team
E
Esmée Smit
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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