Irreversible electroporation (NanoKnife) for advanced perihilar cholangiocarcinoma
- Conditions
- cholangiocarcinoma
- Registration Number
- NL-OMON25184
- Lead Sponsor
- Academic Medical Center (AMC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
Age 18 years or older;
- Capable of providing written and oral informed consent;
Exclusion Criteria
- Resectable PHC upon exploratory laparotomy;
- Locally advanced PHC eligible for liver transplantation;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The total number of clinically relevant complications within 90 days post-IRE, defined as complications requiring re-intervention, prolonged hospital stay, intensive care admission, re-admission or leading to mortality; summarized by a Common Terminology Criteria for Adverse Events (CTCAE, version 4.0) score of 3 or higher.
- Secondary Outcome Measures
Name Time Method - Success rate of completing IRE;<br /><br>- Intra-procedural complications related to IRE;<br /><br>- Duration of hospital stay;<br /><br>- Quality of life;<br /><br>- Impact of IRE on post-procedural CT imaging and blood biomarker response;<br /><br>- Time between IRE and start of palliative chemotherapy;<br /><br>- Progression-free and overall survival.<br>