Comparison of Response and Recurrence Rates Following Percutaneous Microwave Coagulation Therapy Versus Percutaneous Radiofrequency Ablation (Thermoablation)
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ClinicalTrials.gov Identifier: NCT02859753
Recruitment Status : Unknown
Verified July 2016 by Centre Hospitalier Universitaire Dijon. Recruitment status was: Recruiting
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.
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
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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