International Study on Treatment of Liver (HCC) Patients With IRE

NCT ID: NCT07192731

Last Updated: 2025-10-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2029-02-28

Brief Summary

Procedural data will be recorded from patients with liver lesions from hepatocellular cancer who have been assessed by an appropriately constituted MDT (or equivalent) as appropriate to receive irreversible electroporation

Conditions

Hepatocellular Carcinoma (HCC); Liver Ablation; Liver Cancer, Adult

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Other: Use of NanoKnife System for ablation of HCC lesions

Group Type: EXPERIMENTAL

Irreversible Electroporation

Intervention Type: DEVICE

Irreversible electroporation (IRE) is a procedure which involves the passage of short intense electrical pulses between probes to destabilize cell membranes by creating "nanopores" which leads to cell destabilisation and cell death.

IRE can be used to selectively damage cancerous cells whilst sparing adjacent supporting connective tissue in vessels and bile ducts allowing a more targeted treatment compared to other types of ablation. IRE also avoids the heat-sink phenomenon which compromises the effectiveness of thermal ablation and possibly reduces the risks of biliary injury.

Interventions

Irreversible Electroporation

Irreversible electroporation (IRE) is a procedure which involves the passage of short intense electrical pulses between probes to destabilize cell membranes by creating "nanopores" which leads to cell destabilisation and cell death.

IRE can be used to selectively damage cancerous cells whilst sparing adjacent supporting connective tissue in vessels and bile ducts allowing a more targeted treatment compared to other types of ablation. IRE also avoids the heat-sink phenomenon which compromises the effectiveness of thermal ablation and possibly reduces the risks of biliary injury.

Intervention Type: DEVICE

Other Intervention Names

nanoknife

Eligibility Criteria

Inclusion Criteria

• Patients aged 18 years and over, able to provide informed consent and with clinical diagnosis of an HCC. Tissue confirmation of HCC prior to treatment is not standard of care and is therefore not required for this study.
• Child-Pugh A up to A6.
• Eastern Co-operative Oncology Group (ECOG) Score ≤ 2.
• Rockwood Frailty Score ≤ 3.
• Serum bilirubin < 30 µmol/L.
• Serum creatinine < 150 µmol/L.
• No extrahepatic metastases
• IRE can be used for up to 3 tumours < 3cm in size. Other forms of ablation can be combined with IRE in the same sitting but not for the same lesion. IRE can also be combined with surgical resection.

Exclusion Criteria

General:

• Patients involved in other research studies.
• Patients under the age of 18 years.
• Inability to give informed consent.
• Patients who are pregnant.
• Child-Pugh B or C.
• Patients with an ECOG status of > 2 at time of recruitment.
• Rockwood Frailty Score > 3
• Impaired renal function (serum creatinine > 150 µmol/L)
• Accepted exclusions to IRE from consensus criteria including:
• Platelet count < 50x109 U/L.
• International normalised ratio (INR) for blood clotting > 1.7.
• Prior hepatic tumour ablation.

Cardiovascular fitness related exclusions:

• History of ventricular arrhythmia.
• Implanted pacemaker or defibrillator.
• Congestive cardiac failure NYHA Class ≥ 3.

Tumour-related exclusions:

• Tumour ≥ 3 cm in size.
• Extrahepatic metastatic disease.
• Jaundice (serum bilirubin > 30 µmol/L).
• MDT recommends use of thermal ablation for any given lesion.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Angiodynamics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ajith Siriwardena, MD FRCS

Role: PRINCIPAL_INVESTIGATOR

Manchester Royal Infirmiary

Locations

Manchester Royal Infirmiary

Manchester, , United Kingdom

Countries

United Kingdom

Central Contacts

Mitchell Vanderpoll

Role: CONTACT

mvanderpoll@angiodynamics.com

+44 7790921819

Facility Contacts

Ajith Siriwardena, MD FRCS

Role: primary

ajith.siriwardena@mft.nhs.uk

+44

Other Identifiers

2025-ONC-02

Identifier Type: -

Identifier Source: org_study_id