Endoscopic Radiofrequency Ablation for Unresectable Cholangiocarcinoma

Launched by UNIVERSITÄTSKLINIKUM HAMBURG-EPPENDORF · Dec 8, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a treatment called radiofrequency ablation for patients with bile duct cancer (also known as cholangiocarcinoma) that cannot be surgically removed. The researchers want to find out if this treatment can help reduce complications, such as problems with stents (tubes placed to help drainage), delays in chemotherapy, and infections, while also ensuring that the treatment is safe for patients. Participants will continue to receive standard care, which includes chemotherapy and bile duct stenting, but some will also receive the additional radiofrequency ablation treatment.

To qualify for the trial, participants need to be at least 18 years old, have a specific type of advanced bile duct cancer that can't be surgically removed, and be eligible for standard chemotherapy treatment. They should not have had prior radiofrequency ablation for their cancer or complications that could interfere with the study. If eligible, participants can expect regular check-ups and monitoring throughout the trial, and they will be part of a group that either receives the new treatment or standard care alone. This trial aims to provide more information about the effectiveness and safety of radiofrequency ablation in this patient population, which could lead to better treatment options in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Unresectable perihilar and/or ductal CCA with bile duct stenting and palliative systemic therapy as indicated by the local Multidisciplinary Team (MDT)
• • 2. Written informed consent
• • 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• • 4. Age ≥18 years
• • 5. Eligibility for palliative systemic therapy based on clinical and laboratory parameters (except hyperbilirubinemia) as determined by the local MDT
• • 6. No prior radiofrequency ablation (RFA) for CCA
• • 7. No repeated bile duct stenting in the past 3 months (trial inclusion is possible upon first stent replacement or initial stent placement within past 3 months)
• • 8. No concomitant disease or malignancy interfering with the study procedure or efficacy outcome measures, particularly no severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, myocardial infarction within ≤3 months, significant arrhythmias) and no psychiatric disorders precluding understanding of information of trial related topics and giving informed consent