Comparison of Response and Recurrence Rates Following Percutaneous Microwave Coagulation Therapy Versus Percutaneous Radiofrequency Ablation

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Randomized Controlled Study Comparing Response and Recurrence Rates Following Percutaneous Microwave Coagulation Therapy (MCT) Versus Percutaneous Radiofrequency Ablation (RFA) in Patients With Chronic Liver Disease and Hepatocellular Carcinoma

Conditions
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Thermoablation, Chronic Liver Disease, Hepatocellular Carcinoma

Intervention / Treatment
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* Other: Percutaneous Radiofrequency Ablation
* Other: Percutaneous Microwave Ablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RFA<br> | Other: Percutaneous Radiofrequency Ablation<br> <br> |
| Active Comparator: MCT<br> | Other: Percutaneous Microwave Ablation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to disease progression according to American Society of Interventional Radiology criteria |  | Through study completion up to 5 years |