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

Hepatocellular Carcinoma Clinical Trial

— Thermoablation  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02859753
• Other study ID #: GUIU MicroS 2012
• Status: Completed
• Phase: N/A
• Start date: January 15, 2014
• Est. completion date: March 18, 2020

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 18, 2020
• Est. primary completion date: March 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Chronic Liver Disease
• Hepatocellular Carcinoma
• Liver Diseases
• Recurrence
• Thermoablation

Intervention

Other:
• Percutaneous Radiofrequency Ablation

• Percutaneous Microwave Ablation

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to disease progression according to American Society of Interventional Radiology criteria		Through study completion up to 5 years