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IRAL: Immunological Response After Ablative Therapy in the Liver

Sponsor
Karolinska Institutet (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03040453
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
20.9
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Microwave ablation
  • Device: Irreversible electroporation
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Comparison of Immunological Response After Microwave Ablation and Irreversible Electroporation of Hepatocellular Carcinoma
Actual Study Start Date :
Jan 1, 2017
Anticipated Primary Completion Date :
Jun 30, 2018
Anticipated Study Completion Date :
Sep 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: Microwave ablation

20 patients will be treated with microwave ablation

Device: Microwave ablation
Other: Irreversible electroporation

20 patients will be treated with irreversible electroporation

Device: Irreversible electroporation
Other Names:
  • Nano Knife, Angiodynamics

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Surgery and Urology, Danderyd Hospital Stockholm Sweden 18288

    Sponsors and Collaborators

    • Karolinska Institutet

    Investigators

    • Principal Investigator: Jacob Freedman, MD, PhD, Karolinska Instituet

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Karolinska Institutet
    ClinicalTrials.gov Identifier:
    NCT03040453
    Other Study ID Numbers:
    • EPN 2016/2212-31/2
    First Posted:
    Feb 2, 2017
    Last Update Posted:
    Nov 30, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Karolinska Institutet
    Irreversible electroporation
    Microwave ablation
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular

    Study Results

    No Results Posted as of Nov 30, 2020