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

NCT02859753 | Completed

• 1 other identifier: GUIU MicroS 2012
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  Through study completion up to 5 years

Study Arms (2)

RFA

EXPERIMENTAL

Other: Percutaneous Radiofrequency Ablation

MCT

ACTIVE COMPARATOR

Other: Percutaneous Microwave Ablation

Interventions

Percutaneous Radiofrequency Ablation OTHER

RFA

Percutaneous Microwave Ablation OTHER

MCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

Related Publications (1)

• 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.

  PMID: 29503247 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 9, 2016
• Study Start: January 15, 2014
• Primary Completion: March 18, 2020
• Study Completion: March 18, 2020
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

FR (1)