Pilot-study: Non-thermal Ablation Using Irreversible Electroporation to Treat Colorectal Liver Metastases (IRE)
|ClinicalTrials.gov Identifier: NCT01799044|
Recruitment Status : Completed
First Posted : February 26, 2013
Last Update Posted : September 4, 2013
Irreversible electroporation is a new, minimal-invasive image-guided treatment to treat tumors near or around vulnerable structures, such as central liver tumors.
To investigate the safety and efficacy of IRE in the treatment of colorectal liver metastases, patients with resectable colorectal liver metastases undergo IRE and resection of the metastases in the same session. After resection, the specimen is examined macroscopically to determine vitality using a specific vitality staining (triphenyl-tetrazoliumchloride) and to visualize the exact ablation zone. Subsequently, histopathologic examination is used to determine type of cell death and the microscopic ablation zone.
The investigators hypothesize that IRE is a safe effective method to treat colorectal liver metastasis and that cell damage and cell death is demonstrated as soon as 1 hour after the procedure.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Liver Metastases Metastatic Liver Disease||Device: Irreversible electroporation (IRE)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot-study: Non-thermal Ablation Using Irreversible Electroporation (IRE) to Treat Colorectal Liver Metastases - "Ablate and Resect"|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
Experimental: Irreversible electroporation
Single arm study: Irreversible electroporation of colorectal liver metastasis
Device: Irreversible electroporation (IRE)
Tumor ablation with irreversible electroporation with the NanoKnife
- Safety [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1 week ]Safety using Common terminology Criteria for Adverse Events (CTCAE). Since the ablated tissue will be resected we expect procedure-related complications to occur mainly during the procedure.
- Efficacy [ Time Frame: 1 year ]Cell death of CRLM after IRE is demonstrated macroscopically by using vitality-staining with triphenyl-tetrazoliumchloride (TTC). Since and shape of the ablation zone is assessed. Immunohistologic examination is used to more specifically assess microscopic cell damage and vessel wall damage. Apoptotic markers are used.
- Feasibility [ Time Frame: 1 year ]The investigators hypothesize that it will initially take several replacements before adequate positioning is obtained. It is suspected that placement of the electrodes will become easier in the course of the study and that procedure time will decrease (expressed in learning curve).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799044
|VU University Medical Center|
|Amsterdam, Noord-Holland, Netherlands, 1081HV|
|Principal Investigator:||Martijn R Meijerink, MD, PhD||VU University Medical Center|
|Principal Investigator:||Petrousjka M van den Tol, MD, PhD||VU University Medical Center|
|Study Director:||C van Kuijk, Prof. Dr.||VU University Medical Center, head of department of radiology|