Immunological Response After Ablative Therapy in the Liver

Hepatocellular Carcinoma Clinical Trial

— IRAL  

Official title:

Comparison of Immunological Response After Microwave Ablation and Irreversible Electroporation of Hepatocellular Carcinoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03040453
• Other study ID #: EPN 2016/2212-31/2
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: November 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Immune Response

Intervention

Device:
• Microwave ablation

• Irreversible electroporation

Locations

Country	Name	City	State
Sweden	Department of Surgery and Urology, Danderyd Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunological response	Change in immunological response	Change from baseline (morning of the procedure) measured at post operative day 1,7, 28 and 90
Secondary	Number of participants with complete radiological response at follow up 3, 6, 9 and 12 months.	Compare the effect of the two different ablative methods	Follow-up every three months for one year with CT scan.