ThermoablationThermoablationNCT02859753
Comparison of Response and Recurrence Rates Following Percutaneous Microwave Coagulation Therapy Versus Percutaneous Radiofrequency Ablation
A study testing Percutaneous Radiofrequency Ablation and Percutaneous Microwave Ablation in people with Thermoablation and Chronic Liver Disease, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thermoablation, Chronic Liver Disease, Hepatocellular Carcinoma
- What is being tested?
- Percutaneous Radiofrequency Ablation and Percutaneous Microwave Ablation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2014to 18 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Percutaneous Radiofrequency Ablation, Percutaneous Microwave Ablation
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Radiofrequency AblationOther
Percutaneous Microwave AblationOther
| Study group | Role | What they receive |
|---|---|---|
| RFA | Experimental | Not described Receives: Other: Percutaneous Radiofrequency Ablation |
| MCT | Active comparator | Not described Receives: Other: Percutaneous Microwave Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to disease progression according to American Society of Interventional Radiology criteria
Measured: Through study completion up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study start15 Jan 2014
- Primary completion18 Mar 2020
- Study completion18 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThermoablationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859753
- Sponsor's protocol ID
- GUIU MicroS 2012
- Acronym
- Thermoablation
- Status last verified
- Feb 2024
- First submitted
- 1 Aug 2016
- Last updated
- 21 Feb 2024
- Results posted
- No
Publications
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.
PubMed 29503247
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02859753
- Acronym / sponsor ID
- Thermoablation / GUIU MicroS 2012
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 15 Jan 2014 (actual)
- Primary completion
- 18 Mar 2020 (actual)
- Study completion
- 18 Mar 2020 (actual)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RFA | Experimental | Other: Percutaneous Radiofrequency Ablation |
| MCT | Active comparator | Other: Percutaneous Microwave Ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Radiofrequency Ablation | Other | RFA |
| Percutaneous Microwave Ablation | Other | MCT |
Primary outcome
Time to disease progression according to American Society of Interventional Radiology criteria
Time frame: Through study completion up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Derived from this study: PubMed 29503247Vietti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Radiofrequency Ablation and Percutaneous Microwave Ablation in people with Thermoablation and Chronic Liver Disease, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to disease progression according to American Society of Interventional Radiology criteria (time frame: Through study completion up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02859753, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.