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 (PROMETHEUS-study)

Recruiting

Conditions: hepatocellular carninoma
liver cancer
10019815
10019818

Registration Number: NL-OMON55994

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Age 18 yrs 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

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- 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 invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the minimal ablation margin required to achieve a local recurrence<br /><br>rate of < 10% in patients undergoing thermal ablation for HCC</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To analyze the correlation between ablation margins and local recurrence in<br /><br>patients undergoing thermal ablation for HCC<br /><br>- To assess the efficacy of thermal ablation in a large cohort of HCC patients</p><br>