Chronic Liver Disease, Hepatocellular Carcinoma, Thermoablation
Conditions
Brief summary
To date, the majority of studies that have evaluated the efficacy of microwave ablation (MWA) in the treatment of hepatocellular carcinoma (HCC) lesions in cirrhotic patients and compared its efficacy with that of percutaneous radiofrequency ablation (RFA) for local recurrence and survival have been retrospective. There have been no prospective randomized studies comparing percutaneous microwave ablation (PMWA) with RFA for ablated tumour volume, the response after one session, local recurrence rates in the first year, complication rates and survival at 3 and 5 years for HCC lesions \> 2 cm in patients with Child-Pugh A and B cirrhosis. The hypothesis the investigators wish to explore is that though the 2 methods are equivalent for lesions ≤ 2 cm, MWA could show better efficacy with a similar risk for lesions \> 2 cm and for lesions close to vessels ≥ 3 mm in diameter, as shown in retrospective studies.
Interventions
OTHERPercutaneous Microwave Ablation
Sponsors
Centre Hospitalier Universitaire Dijon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient who have been informed about the research and given their oral consent * Patients with national health insurance cover * Patients ≥ 18 years * ≤ 3 CHC lesions ≤ 4 cm, with a maximum of 3 lesions with a diagnosis of HCC based on histology, or according to European Society for the Study of the Liver (EASL) criteria * Chronic liver disease or cirrhosis with a Child-Pugh score between 5 and 8 points * Contra-indication for surgical resection at the time of the therapeutic decision made during a multidisciplinary meeting
Exclusion criteria
* Informed consent not obtained (refusal of patient or patient lacking discernment) * Kidney failure with creatinine clearance \< 30 ml/min thus preventing the injection of contrast for the initial or follow-up radiological imaging * Presence of a malignant tumour other than the HCC at the time of the diagnosis, unless a basocellular carcinoma * Cirrhosis with a Child-Pugh score \> 8 * Contra-indication for percutaneous treatment according to Barcelona Clinic Liver Cancer (BCLC) criteria * Patients without national health insurance cover
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to disease progression according to American Society of Interventional Radiology criteria | Through study completion up to 5 years |
Countries
France
Outcome results
None listed