Comparison of Response and Recurrence Rates Following Percutaneous Microwave Coagulation Therapy Versus Percutaneous Radiofrequency Ablation (Thermoablation)
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| ClinicalTrials.gov Identifier: NCT02859753 |
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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
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Sponsor:
Centre Hospitalier Universitaire Dijon
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon
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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 |
| 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 :
- Time to disease progression according to American Society of Interventional Radiology criteria [ Time Frame: Through study completion up to 5 years ]
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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
| Contact: Boris GUIU | 03.80.29.36.86 ext 33 | boris.guiu@chu-dijon.fr |
Locations
| 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):
| 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 |