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

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.

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Key information

Conditions

Thermoablation Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Chronic Liver Disease Digestive System Diseases Digestive System Neoplasms Hepatocellular Carcinoma Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Dijon Bourgogne

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous Radiofrequency Ablation

Other

Percutaneous Microwave Ablation

Other

Primary outcomes

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

Time frame: Through study completion up to 5 years

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study 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

Acronym: Thermoablation

Important dates

Study start: 2014
Primary completion: 2020
Study completion: 2020
First posted: Aug 9, 2016
Registry last updated: Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed