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Microwave Ablation Versus Resection for Resectable Colorectal Liver Metastases

NCT02642185 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 102

Last updated 2022-03-31

No results posted yet for this study

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.

Conditions

  • Neoplasm Metastasis

Interventions

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

PROCEDURE

Resection

Open or laparoscopic resection of liver metastases using standard of care surgical procedures

Sponsors & Collaborators

Principal Investigators

  • Jacob Freedman, MD, PhD · Karolinska Institutet

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-01
Primary Completion
2022-01-01
Completion
2022-01-01

Countries

  • Netherlands
  • Sweden
  • Switzerland

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02642185 on ClinicalTrials.gov