Using radiofrequency ablation to treat bile duct cancer before stent placement
Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma: a Randomized Controlled Trial
This study is testing if using a special heat treatment before placing a stent can help people with bile duct cancer feel better and keep their stents working longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT05546372 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the effectiveness of endobiliary radiofrequency ablation (eRFA) followed by the placement of a metal stent against stent placement alone in patients with inoperable perihilar cholangiocarcinoma. It is a multicenter, parallel group, open-label, randomized controlled trial designed to assess whether eRFA can improve stent patency and patient outcomes. Participants will be randomly assigned to one of the two treatment groups to evaluate the potential benefits of the combined approach. The study aims to provide insights into the management of biliary obstruction caused by this type of cancer.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed perihilar cholangiocarcinoma who are not candidates for surgical resection.
Not a fit: Patients who are eligible for curative resection or liver transplantation will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance stent patency and improve quality of life for patients with malignant biliary obstruction.
How similar studies have performed: Other studies have shown promising results with radiofrequency ablation in similar contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older. * Capable of providing written and oral informed consent. * Histological or cytological proof of perihilar CCA (adenocarcinoma). * Perihilar biliary obstruction with an indication for drainage with uSEMS.\* * Advanced (no candidate for surgical resection) due to metastases, vascular or lymph node (N2) involvement on imaging or during staging laparoscopy according to multidisciplinary team (MDT). * Only patients with pCCA are eligible however in case of reasonable doubt between intrahepatic CCA with a perihilar biliary obstruction or massforming pCCA, patients can be included. Exclusion Criteria: * Patients who potentially qualify for curative resection of pCCA. * pCCA eligible for liver transplantation. * Life-expectancy less than 3 months. * ERCP and PTC technically not feasible. * Uncontrolled coagulopathy (PTT \>1,5x prolonged or thrombocytes below 40\*10E9/L). * Ongoing cholangitis or liver abscess. Patients are required to be off antibiotic treatment for cholangitis and/or liver abscess at least 7 days. * Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study. * Patients who are pregnant or breastfeeding.
Where this trial is running
Amsterdam
- Amsterdam UMC location VUmc — Amsterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Jeska Fritzsche
- Email: j.a.fritzsche@amsterdamumc.nl
- Phone: +31204440613
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.