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Microwave Ablation Versus Resection for Resectable Colorectal Liver Metastases (MAVERRIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02642185
Recruitment Status : Active, not recruiting
First Posted : December 30, 2015
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Jacob Freedman, Karolinska Institutet

Brief Summary:

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

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Study Type : Observational [Patient Registry]
Actual Enrollment : 102 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Microwave Ablation Versus Resection for Resectable Colorectal Liver Metastases
Study Start Date : December 2015
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2028

Group/Cohort Intervention/treatment
Ablation
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

Resection
Patients identified in the Swedish liver registry during the same time frame subjected to liver resection, propensity score matched to the ablation group
Procedure: Resection
Open or laparoscopic resection of liver metastases using standard of care surgical procedures




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]
  2. Overall survival [ Time Frame: 10 years ]
  3. Complications to treatment [ Time Frame: 1 year ]
  4. Disease free survival [ Time Frame: 3 years ]
  5. 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.

  6. Local recurrence rates [ Time Frame: 3 years ]
  7. Accuracy of placement of ablative device measured as mm from needle target location [ Time Frame: intraoperative ]
  8. Analysis of ablation volumes measured as length and radius of ovoid ablation zone. [ Time Frame: 1-28 days post intervention ]
  9. Need for further liver specific treatment as assessed by number of sessions with ablation or resections [ Time Frame: 5 years ]


Information from the National Library of Medicine

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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
Study Population

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.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT02642185


Locations
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Netherlands
University Medical Centre
Groningen, Netherlands
Sweden
Karolinska Institutet, Dept of Surgery at Danderyd Hospital
Stockholm,, Sweden, 18288
Switzerland
Pascale Tinguely
Bern, Switzerland
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Jacob Freedman, MD, PhD Karolinska Institutet

Additional Information:

Publications:
www.livermetsurvey.com, annual statistics june 2014.

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Responsible Party: Jacob Freedman, Prof, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02642185    
Other Study ID Numbers: MAVERRIC
First Posted: December 30, 2015    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Keywords provided by Jacob Freedman, Karolinska Institutet:
microwave
ablation
resection
liver
colorectal
survival
metastasis
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Neoplastic Processes
Neoplasms
Pathologic Processes
Liver Extracts
Hematinics