MedTrace Logo

Pilot-study: Non-thermal Ablation Using Irreversible Electroporation to Treat Colorectal Liver Metastases

NCT01799044 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-12-20

No results posted yet for this study

Summary

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.

Conditions

  • Colorectal Liver Metastases
  • Metastatic Liver Disease

Interventions

DEVICE

Irreversible electroporation (IRE)

Tumor ablation with irreversible electroporation with the NanoKnife

Sponsors & Collaborators

  • Amsterdam UMC, location VUmc

    collaborator OTHER

  • Dr. M.R. Meijerink

    lead OTHER

Principal Investigators

  • Martijn R Meijerink, MD, PhD · Amsterdam UMC, location VUmc

  • Petrousjka M van den Tol, MD, PhD · Amsterdam UMC, location VUmc

  • C van Kuijk, Prof. Dr. · VU University Medical Center, head of department of radiology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Netherlands

Study Locations

More Related Trials

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 NCT01799044 on ClinicalTrials.gov