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Immunological Response After Ablative Therapy in the Liver

NCT ID: NCT03040453

Last Updated: 2020-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma Immune Response

Keywords

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Irreversible electroporation Microwave ablation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Microwave ablation

20 patients will be treated with microwave ablation

Group Type OTHER

Microwave ablation

Intervention Type DEVICE

Irreversible electroporation

20 patients will be treated with irreversible electroporation

Group Type OTHER

Irreversible electroporation

Intervention Type DEVICE

Interventions

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Microwave ablation

Intervention Type DEVICE

Irreversible electroporation

Intervention Type DEVICE

Other Intervention Names

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Nano Knife, Angiodynamics

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacob Freedman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Instituet

Locations

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Department of Surgery and Urology, Danderyd Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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EPN 2016/2212-31/2

Identifier Type: -

Identifier Source: org_study_id