Microwave Ablation Versus Resection for Resectable Colorectal Liver Metastases (MAVERRIC)
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|ClinicalTrials.gov Identifier: NCT02642185|
Recruitment Status : Completed
First Posted : December 30, 2015
Last Update Posted : March 31, 2022
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This study aims to prove that a strategy of first line local ablation of colorectal liver metastases with microwaves is not inferior to liver resections in terms of survival rates at three years with secondary endpoints being survival at five and ten years, interventional complication rates, length of stay, ablation precision measurements, need for further interventions and health-economic analysis.
A cohort of 100 patients treated with CT guided microwave ablation of 1-5 metastases <31mm in size will be followed and compared with propensity scored matched controls from the Swedish liver surgery registry - Sweliv.
The study is a multi-institutional effort by the Hepato Pancreatico Biliary (HPB) units in Stockholm Sweden, Bern Switzerland and Groningen in the Netherlands.
|Condition or disease||Intervention/treatment|
|Neoplasm Metastasis||Procedure: Microwave ablation Procedure: Resection|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||102 participants|
|Target Follow-Up Duration:||10 Years|
|Official Title:||Microwave Ablation Versus Resection for Resectable Colorectal Liver Metastases|
|Actual Study Start Date :||December 1, 2015|
|Actual Primary Completion Date :||January 1, 2022|
|Actual Study Completion Date :||January 1, 2022|
Patients that are primarily treated with microwave ablation of colorectal liver metastases
Procedure: Microwave ablation
CT-guided percutaneous ablation of 1-5, <31mm in diameter, colorectal liver metastases, performed with any generic microwave ablation system cleared for clinical use
Patients identified in the Swedish liver registry during the same time frame subjected to liver resection, propensity score matched to the ablation group
Open or laparoscopic resection of liver metastases using standard of care surgical procedures
- Overall survival [ Time Frame: 3 years ]
- Overall survival [ Time Frame: 5 years ]
- Overall survival [ Time Frame: 10 years ]
- Complications to treatment [ Time Frame: 1 year ]
- Disease free survival [ Time Frame: 3 years ]
- Overall cost of treatment as measured in euros [ Time Frame: 3 years ]The aggregated health provider's costs for all liver specific treatments including index surgery and hospital costs, costs for further liver specific interventions.
- Local recurrence rates [ Time Frame: 3 years ]
- Accuracy of placement of ablative device measured as mm from needle target location [ Time Frame: intraoperative ]
- Analysis of ablation volumes measured as length and radius of ovoid ablation zone. [ Time Frame: 1-28 days post intervention ]
- Need for further liver specific treatment as assessed by number of sessions with ablation or resections [ Time Frame: 5 years ]
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|Ages Eligible for Study:||18 Years to 90 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
European multicentre prospective cohort study with propensity score matching for number or tumours, age, gender and response to chemotherapy (no chemo - response/stable disease - progression).
Patients with colorectal liver metastases are evaluated at a weekly liver multidisciplinary conference and a treatment strategy is decided. In this decision process patients that are resectable and have tumours of 30mm or less and not more than 5 in number, and deemed as both ablatable and resectable, will be offered treatment with an ablative strategy using state of the art targeting and microwave ablation devices.
- Patients with 1-5 colorectal liver metastases
- No metastases larger than 30 mm in diameter
- All lesions amenable to CT-guided percutaneous microwave ablation
- Patient also resectable
- Patients so evaluated at the multidisciplinary tumor board meeting
- Kidney failure excluding the use of iv contrast medium
- Lack of informed consent
- Logistic reasons where patient does not live in the region of the treatment centre
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): NCT02642185
|University Medical Centre|
|Karolinska Institutet, Dept of Surgery at Danderyd Hospital|
|Stockholm,, Sweden, 18288|
|Principal Investigator:||Jacob Freedman, MD, PhD||Karolinska Institutet|
|Responsible Party:||Jacob Freedman, Prof, Karolinska Institutet|
|Other Study ID Numbers:||
|First Posted:||December 30, 2015 Key Record Dates|
|Last Update Posted:||March 31, 2022|
|Last Verified:||March 2022|