Clinical Effectiveness of Microwave Ablation Using Starwave Microwave Generator for Hepatic Malignancies

Not Applicable

Recruiting

• Conditions: Liver Malignant Tumors
• Interventions: Procedure: Microwave ablation

• Registration Number: NCT06426992
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The purpose of this study is to determine the technical success rate of creating a safety margin of 5 mm or more including the tumor by performing image-guided percutaneous microwave thermal therapy using a microwave generator and antenna developed by StarMed for the treatment of small liver cancer and the 1-year local recurrence rate based on follow-up imaging tests.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-30
• Status Verified: 2024-05
• Study First Submitted: 2024-05-19
• Study First Submitted QC: 2024-05-19
• Last Update Submitted: 2024-05-19
• Study First Posted: 2024-05-23
• Last Update Posted: 2024-05-23
• Primary Completion: 2026-03-30
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Child-Pugh Class A or B
• Patients with suspected hepatocellular carcinoma or residual/recurrent hepatocellular carcinoma of 4 cm or less on MDCT, CEUS, or MRI performed within the last 60 days or Patients with suspected metastatic liver cancer of 4 cm or less on MDCT, CEUS, or MRI performed within the last 60 days, for whom microwave thermal ablation is being considered

Exclusion Criteria

• In cases where there are three or more malignant liver tumors
• When the maximum size of the tumor exceeds 4 cm
• Diffuse infiltrative type of cancer with unclear tumor boundaries
• When the tumor is adhered to the central hepatic portal vein, hepatic vein, or bile duct by 5 mm or more
• Severe liver failure (Child-Pugh Class C)
• In cases of vascular invasion by malignant liver tumors
• Severe coagulopathy (platelet count below 50,000/mm³ or INR prolonged by more than 50%)
• In cases of multiple extrahepatic metastases
• Situations where it is highly unlikely to obtain appropriate data for research purposes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with malignant liver tumors	Microwave ablation	Following the existing procedure of our institute, we aim to treat the tumor by applying up to 150W of microwaves within the tumor using a StarWave microwave generator and a 13-gauge antenna under fusion ultrasound guidance. If necessary, the antenna is reinserted 1-2 times to create sufficient ablation lesions until an echogenic band of 5-10mm is formed around the tumor and its periphery, implementing overlapping microwave ablation (MWA). Afterward, the antenna is removed while applying microwave energy to prevent bleeding.

Primary Outcome Measures

Name	Time	Method
Technical success	Immediately after ablation	Technical success addresses whether the index tumor was treated according to a predefined protocol and entirely covered by the ablation zone.
Local tumor progression rate	12 months after ablation	Local tumor progression, defined as the appearance of tumor foci at the margin of the ablation zone after the attainment of treatment success

Secondary Outcome Measures

Name	Time	Method
Recurrence-free survival	12 months after ablation	Recurrence-free survival was defined as the interval between ablation and the date of any type of recurrence or the last follow-up date if there was no recurrence.
Complication after ablation	Immediately, 1 month, 3 months, 6 months, 9 months, and 12 months after radiofrequency ablation	Post ablation complications were defined as problems noted within 1 month after MWA as well as additional complications identified on follow-up imaging and judged to be likely caused by ablation.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of