Clinical trial NCT02859753: Comparison of Response and Recurrence Rates Following Percutaneous Microwave Coagulation Therapy Versus Percutaneous Radiofrequency Ablation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thermoablation
Chronic Liver Disease
Hepatocellular Carcinoma
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to disease progression according to American Society of Interventional Radiology criteria
timeFrame: Through study completion up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
citation: Vietti Violi N, Duran R, Guiu B, Cercueil JP, Aube C, Digklia A, Pache I, Deltenre P, Knebel JF, Denys A. Efficacy of microwave ablation versus radiofrequency ablation for the treatment of hepatocellular carcinoma in patients with chronic liver disease: a randomised controlled phase 2 trial. Lancet Gastroenterol Hepatol. 2018 May;3(5):317-325. doi: 10.1016/S2468-1253(18)30029-3. Epub 2018 Mar 2.