Immunological Response After Ablative Therapy in the Liver

NCT03040453 | Withdrawn

• 1 other identifier: EPN 2016/2212-31/2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma; Immune Response

Keywords

Irreversible electroporation; Microwave ablation

Outcome Measures

Primary Outcomes (1)

• Immunological response

  Change in immunological response

  Change from baseline (morning of the procedure) measured at post operative day 1,7, 28 and 90

Secondary Outcomes (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.

Study Arms (2)

Microwave ablation

OTHER

20 patients will be treated with microwave ablation

Device: Microwave ablation

Irreversible electroporation

OTHER

20 patients will be treated with irreversible electroporation

Device: Irreversible electroporation

Interventions

Microwave ablation DEVICE

Microwave ablation

Irreversible electroporation DEVICE

Also known as: Nano Knife, Angiodynamics

Irreversible electroporation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Department of Surgery and Urology, Danderyd Hospital

Stockholm, 18288, Sweden

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Electroporation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Officials

• Jacob Freedman, MD, PhD

  Karolinska Instituet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: February 2, 2017
• Study Start: January 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: September 30, 2018
• Last Updated: November 30, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)