CompletedNot Applicable

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

France35 participantsStarted 2014-01-15

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Time to disease progression according to American Society of Interventional Radiology criteria

Timeframe: Through study completion up to 5 years

Trial details

NCT IDNCT02859753

SponsorCentre Hospitalier Universitaire Dijon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-18