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NCT02859753: Thermoablation

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

Completed NA Last updated 21 February 2024
What this trial tests

NA trial testing Percutaneous Radiofrequency Ablation in Thermoablation in 35 participants. Completed in 18 March 2020.

Timeline
15 January 2014
Primary endpoint
18 March 2020
18 March 2020

Quick facts

Lead sponsorCentre Hospitalier Universitaire Dijon
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeother
Enrollment35
Start date15 January 2014
Primary completion18 March 2020
Estimated completion18 March 2020
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Centre Hospitalier Universitaire Dijon

Who can join

18 and older, any sex, with Thermoablation or Chronic Liver Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. 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.
    Vietti Violi N, Duran R, Guiu B, Cercueil JP, et al · · 2018 · cited 196× · PMID 29503247 · DOI 10.1016/s2468-1253(18)30029-3

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Other trials of Percutaneous Radiofrequency Ablation

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