PROspective Multi-center study to Evaluate the correlation between safety margin and local recurrence after THErmal ablation USing image co-registration in patients with hepatocellular carcinoma
- Conditions
- Hepatocellular carcinoma
- Registration Number
- NL-OMON25324
- Lead Sponsor
- MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 165
·Age 18 years or above
·HCC very early (0) or early stage (A) according to the BCLC staging system OR HCC intermediate stage (B) with a maximum of two lesions of =5cm each
·Either de novo or recurrent HCC (prior locoregional therapy is allowed in the study)
·Candidate for percutaneous thermal ablation as discussed in a multidisciplinary tumor board
·Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
·Written informed consent
· Estimated GFR <30 ml/min
· Known severe allergy to contrast medium
· ASA classification higher than 3
· Child Pugh C
· ECOG =1 (tumor-related)
· Portal vein tumor invasion
· Extrahepatic metastasis
· Neoadjuvant transarterial therapy (TACE, TAE or TARE), i.e. combination therapy of transarterial therapy with ablation
· Uncorrectable coagulopathy
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Minimal ablation margin that results in a local recurrence rate <10%
- Secondary Outcome Measures
Name Time Method -Local recurrence at 1 year after thermal ablation at different categories for minimal ablation margin: <0mm, 0-3mm, 3-5mm, >5mm<br>-Local & overall recurrence rate, disease-free and overall survival at 1, 2 and 3 years<br>-Relation between local recurrence at 1 year and disease-free and overall survival