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Immunological Response After Ablative Therapy in the Liver (IRAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03040453
Recruitment Status : Withdrawn (poor recruitment)
First Posted : February 2, 2017
Last Update Posted : November 30, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Immune Response Device: Microwave ablation Device: Irreversible electroporation Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : January 1, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : September 30, 2018

Arm Intervention/treatment
Microwave ablation
20 patients will be treated with microwave ablation
Device: Microwave ablation
Irreversible electroporation
20 patients will be treated with irreversible electroporation
Device: Irreversible electroporation
Other Name: Nano Knife, Angiodynamics




Primary Outcome Measures :
  1. Immunological response [ Time Frame: 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. [ Time Frame: Follow-up every three months for one year with CT scan. ]
    Compare the effect of the two different ablative methods



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040453


Locations
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Sweden
Department of Surgery and Urology, Danderyd Hospital
Stockholm, Sweden, 18288
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Jacob Freedman, MD, PhD Karolinska Instituet
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Responsible Party: Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03040453    
Other Study ID Numbers: EPN 2016/2212-31/2
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: November 30, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases