Liver cancer Cancer
Conditions
Interventions
Irreversible Electroporation (IRE) is a novel method for focused treatment of liver tumors. IRE is a soft tissue ablation technique using ultra short but strong electrical fields to create permanent a
Sponsors
University Hospital Regensburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients must be scheduled for CT guided percutaneous IRE in the liver 2. Written informed consent 3. Male patients and non-pregnant, non-lactating females aged =18 years of age (negative serum/urine pregnancy test result at screening)
Exclusion criteria
Exclusion criteria: 1. Any condition which, in the judgment of the clinical investigator or his designee, might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study 2. A mental condition rendering the patient unable to provide informed consent 3. Patients with hereditary haematological / coagulation disorders unrelated to their liver disease. 4. Patients who are currently (within the last 30 days prior to surgery) participating in another clinical trial with any investigational drug or device 5. Patients undergoing liver surgery for the purpose of receiving a liver transplant or for liver trauma 6. Patients with established renal insufficiency (Creatinine >2.5 mg/dl), or a condition requiring hemodialysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time required for the placement of IRE needles (measured from the time of the first CT scan to the start of the ablation). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Accuracy of IRE needle placement compared to a patient-specific ablation strategy (accuracy is measured as distance to the target point, distance between needles, angles between needles) 2. Overall procedure time 3. Number of lesions treated per patient 4. Number of needle replacements 5. Number of control scans 6. Radiation dose | — |
Countries
Germany
Outcome results
None listed