Immunological Response After Ablative Therapy in the Liver

Not Applicable

Withdrawn

• Conditions: Immune Response; Hepatocellular Carcinoma
• Interventions: Device: Microwave ablation; Device: Irreversible electroporation

• Registration Number: NCT03040453
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-01-20
• Study First Submitted QC: 2017-02-01
• Study First Posted: 2017-02-02
• Primary Completion: 2018-06-30
• Study Completion: 2018-09-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-26
• Last Update Posted: 2020-11-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

• Atrial fibrillation (for irreversible electroporation)
• Pacemaker (for irreversible electroporation)
• >3 lesions
• > 30 mm in any cross section diameter

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microwave ablation	Microwave ablation	20 patients will be treated with microwave ablation
Irreversible electroporation	Irreversible electroporation	20 patients will be treated with irreversible electroporation

Primary Outcome Measures

Name	Time	Method
Immunological response	Change from baseline (morning of the procedure) measured at post operative day 1,7, 28 and 90	Change in immunological response

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Surgery and Urology, Danderyd Hospital; 🇸🇪 Stockholm, Sweden