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

Not Applicable

Completed

• Conditions: Chronic Liver Disease; Hepatocellular Carcinoma; Thermoablation
• Interventions: Other: Percutaneous Radiofrequency Ablation; Other: Percutaneous Microwave Ablation

• Registration Number: NCT02859753
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-15
• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-08-04
• Study First Posted: 2016-08-09
• Primary Completion: 2020-03-18
• Study Completion: 2020-03-18
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RFA	Percutaneous Radiofrequency Ablation	-
MCT	Percutaneous Microwave Ablation	-

Primary Outcome Measures

Name	Time	Method
Time to disease progression according to American Society of Interventional Radiology criteria	Through study completion up to 5 years

Trial Locations

Locations (1)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France