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

NCT ID: NCT02859753

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-15
• Study Completion Date: 2020-03-18

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.

Conditions

Thermoablation; Chronic Liver Disease; Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

RFA

Group Type: EXPERIMENTAL

Percutaneous Radiofrequency Ablation

Intervention Type: OTHER

MCT

Group Type: ACTIVE_COMPARATOR

Percutaneous Microwave Ablation

Intervention Type: OTHER

Interventions

Percutaneous Radiofrequency Ablation

Intervention Type: OTHER

Percutaneous Microwave Ablation

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Dijon Bourgogne

Dijon, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 29503247 (View on PubMed)

Other Identifiers

GUIU MicroS 2012

Identifier Type: -

Identifier Source: org_study_id