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A prospective study to assess the clinical performance and safety of the irreversible electroporation in patients with malignant liver tumors

A prospective study to assess the clinical perfomance and safety of the irreversible electroporation(IRE) in patients with hepatocellular carcinoma or metastatic lesion(smaller than 3cm and lesser than 3) Pilot study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010562
Enrollment
10
Registered
2025-05-29
Start date
2025-06-27
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : Percutaneous IRE Procedure (1) The procedure is performed in an ultrasound suite equipped with fusion imaging technology. (2) After general anesthesia is induced, a nasogastric tub

Sponsors

Samsung Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Individuals who are legally recognized as adults under the Civil Act (age 19 or older) Individuals willing to provide written consent for participation Lesions identified on CT or MRI that meet the following criteria (based on CT/MRI performed within 2 months prior to the procedure) - Liver tumors measuring 3 cm or smaller in size - Three or fewer liver tumors - Liver tumors located within 10 mm of blood vessels, bile ducts, the gallbladder, diaphragm, or gastrointestinal tract Individuals who are not suitable candidates for surgery due to underlying liver disease or other conditions Patients who meet the above treatment criteria and agree to undergo irreversible electroporation therapy

Exclusion criteria

Exclusion criteria: Patients for whom general anesthesia is contraindicated Patients with a planned surgical resection of the lesion Patients who have implanted electrical devices such as a pacemaker or defibrillator, or other metallic implants Patients with coagulopathy (platelet count below 50,000 or INR = 1.5)

Design outcomes

Primary

MeasureTime frame
Major Adverse Events

Secondary

MeasureTime frame
Overall Survival;Time to Recurrence;Local Tumor Control;Proportion of Adverse Events Within 3 Months

Countries

Korea, Republic of

Contacts

Public ContactMin Woo Lee

Samsung Medical Center

leeminwoo0@gmail.com+82-2-3410-2500

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026