Immunological Response After Ablative Therapy in the Liver (IRAL)

Karolinska Institute

Status: Withdrawn

Conditions: Immune Response; Hepatocellular Carcinoma

Treatments: Device: Irreversible electroporation; Device: Microwave ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT03040453

EPN 2016/2212-31/2

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Microwave ablation

Other group

Description:

20 patients will be treated with microwave ablation

Treatment:

Device: Microwave ablation

Irreversible electroporation

Other group

Description:

20 patients will be treated with irreversible electroporation

Treatment:

Device: Irreversible electroporation