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

February 19, 2024 updated by: Centre Hospitalier Universitaire Dijon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • CHU Dijon Bourgogne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RFA
Other: Percutaneous Radiofrequency Ablation
Active Comparator: MCT
Other: Percutaneous Microwave Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to disease progression according to American Society of Interventional Radiology criteria
Time Frame: Through study completion up to 5 years
Through study completion up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2014

Primary Completion (Actual)

March 18, 2020

Study Completion (Actual)

March 18, 2020

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

August 4, 2016

First Posted (Estimated)

August 9, 2016

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GUIU MicroS 2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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