Hepatocellular Carcinoma, Immune Response
Conditions
Keywords
Irreversible electroporation, Microwave ablation
Brief summary
Local ablative treatment of Hepatocellular Carcinoma is performed primary on patients not eligible for liver transplant or liver resection. At our Hospital two different methods are used: Microwave ablation, where the tumor cells are heated up and killed, and Irreversible electroporation, where the tumor cells are exposed to an electrical field and nano-pores are formed in the cell membranes and the cells go into apoptosis (programed cell death). Previous studies have shown effects on the immune system after ablative therapies. The purpose of this study is to compare the immunological response after the wo different methods of killing the tumor cells.
Interventions
DEVICEMicrowave ablation
DEVICEIrreversible electroporation
Sponsors
Karolinska Institutet
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hepatocellular carcinoma, maximum 3 lesions, maximum 30 mm in any cross section diameter * Physically fit to undergo general anaesthesia * Fully understand swedish instructions regarding the study
Exclusion criteria
* Atrial fibrillation (for irreversible electroporation) * Pacemaker (for irreversible electroporation) * \>3 lesions * \> 30 mm in any cross section diameter
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunological response | Change from baseline (morning of the procedure) measured at post operative day 1,7, 28 and 90 | Change in immunological response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with complete radiological response at follow up 3, 6, 9 and 12 months. | Follow-up every three months for one year with CT scan. | Compare the effect of the two different ablative methods |
Countries
Sweden
Outcome results
None listed