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

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ClinicalTrials.gov Identifier: NCT02859753
Recruitment Status : Unknown
Verified July 2016 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Recruiting
First Posted : August 9, 2016
Last Update Posted : August 9, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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.

Condition or disease Intervention/treatment Phase
Thermoablation Chronic Liver Disease Hepatocellular Carcinoma Other: Percutaneous Radiofrequency Ablation Other: Percutaneous Microwave Ablation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Study Start Date : January 2014
Estimated Primary Completion Date : October 2019

Arm Intervention/treatment
Experimental: RFA Other: Percutaneous Radiofrequency Ablation
Active Comparator: MCT Other: Percutaneous Microwave Ablation



Primary Outcome Measures :
  1. Time to disease progression according to American Society of Interventional Radiology criteria [ Time Frame: Through study completion up to 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02859753


Contacts
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Contact: Boris GUIU 03.80.29.36.86 ext 33 boris.guiu@chu-dijon.fr

Locations
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France
CHU Dijon Bourgogne Recruiting
Dijon, France, 21079
Contact: Boris GUIU    03 80 29 36 86 ext 33    boris.guiu@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02859753    
Other Study ID Numbers: GUIU MicroS 2012
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Liver Diseases
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Disease Attributes
Pathologic Processes