Using radiofrequency ablation to treat bile duct cancer before stent placement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Amsterdam UMC location VUmc
  Amsterdam, Netherlands Recruiting

Study contacts

• Study coordinator: Esmée Smit
• Email: e.smit1@amsterdamumc.nl
• Phone: +31204440613

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Liver transplantation for patients with advanced bile duct cancer

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• Robot-assisted surgery for perihilar cholangiocarcinoma

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• Using PD-1 antibody and GEMOX for treating perihilar cholangiocarcinoma after surgery

  This study is testing if a combination of a PD-1 antibody and GEMOX chemotherapy can help patients with perihilar cholangiocarcinoma who have had surgery and have cancer in their lymph nodes live longer and feel better.

  Recruiting Phase 2 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, Guangdong · NCT05430698

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.