NCT02082782

Efficacy of Irreversible Electroporation (IRE) for Central Colorectal Liver Metastases

Colorectal Metastatic Liver Disease: Efficacy of Irreversible Electroporation (IRE) - a Phase II Clinical Trial (COLDFIRE-2 Study)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels and bile ducts. With IRE, multiple electrical pulses are applied to tumorous tissue. These pulses alter the existing transmembrane potential of the cell membranes, and create 'nanopores', after which the cell dies through loss of homeastasis. The purpose of this study is to investigate the efficacy of percutaneous and open IRE in the treatment of patients with colorectal liver metastases (CRLM) that are unsuitable for resection or thermal ablation due to vicinity to vulnerable structures such as vessels and bile ducts. Other objectives are safety, feasibility (technical success) and imaging characteristics on follow-up (PET-)CT and PET-MRI and the value of these imaging modalities in dianosing local site recurrence (LSR) or residual disease (RD). 29 patients with histologically confirmed colorectal carcinoma who present with unresectable and not thermally ablative CRLM\< 3.5cm suitable for IRE will undergo percutaneous or open irreversible electroporation of the tumor using CT and ultrasound guidance. All (serious) adverse events are registered. One day post-IRE MRI is performed to assess technical success. Follow-up will consist of frequent (PET-)CT and (PET-)MRI scanning to localize residual or recurrent disease. Overall technique effectiveness is determined 1 year after treatment. The investigators hypothesize that IRE for central CRLM will lead to good tumor control without causing severe complications.

Conditions

• Colorectal Liver Metastases

Interventions

Type	Name	Description
PROCEDURE	Irreversible electroporation (IRE)	Percutaneous (CT-guided) or open (US-guided) irreversible electroporation of central colorectal liver metastasis.

Timeline

• Start date: 2014-05-01
• Primary completion: 2017-05-01
• Completion: 2020-05-01
• First posted: 2014-03-10
• Last updated: 2022-12-20

Locations

3 sites across 1 country: Netherlands