Evaluation of Clinical Effectiveness of Microwave Ablation Using Starwave Microwave Generator for Small Liver Malignancies: A Prospective Single Center Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Technical success
Study Overview
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
Study Design and-Purpose: This is a prospective, single-center clinical study to evaluate the effectiveness of microwave ablation (MWA) for treating small liver malignancies using the Starwave™ microwave generator and antenna. The primary purpose is to assess the 12-month local tumor recurrence rate. Secondary objectives include evaluating the technical success of achieving a ≥5 mm safety margin around the tumor, as well as procedural time, ablation volume, and safety.
Background: Hepatocellular carcinoma (HCC) and metastatic liver tumors are major causes of cancer-related death worldwide. For small tumors (≤5 cm), thermal ablation techniques like Radiofrequency Ablation (RFA) and Microwave Ablation (MWA) are common treatment options, especially for patients who are not candidates for surgery. MWA offers several advantages over traditional RFA, including faster ablation times, larger ablation zones, and less susceptibility to the "heat sink" effect from nearby blood vessels. Achieving a sufficient safety margin (5-10 mm) around the tumor is critical to prevent local recurrence.
The Starwave™ MWA system, a domestic product in Korea, can deliver a higher maximum power output (150W) compared to some existing systems (e.g., Emprint™, 100W), potentially enabling more efficient energy delivery and larger, more spherical ablation zones. This study aims to prospectively evaluate the 12-month outcomes of this system, as no such data currently exists.
Eligibility Criteria The study will enroll 128 patients who meet the following key criteria. Inclusion Criteria: 1) Age 20-85 years; 2) Diagnosed with liver malignancy ≤4 cm in size (HCC, metastatic cancer, or recurrent/residual HCC); 3) Child-Pugh class A or B liver function; 4) Provided informed consent.
Exclusion Criteria:1) More than 3 malignant liver tumors; 2)Tumors larger than 4 cm; 3) Diffuse infiltrative type cancer;4) Severe coagulopathy or liver failure (Child-Pugh class C); 5) Tumor invasion into major hepatic vessels; 6) Intervention and Follow-up
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Experimental: Patients with Malignant Liver Tumors
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.
Intervention: Starwave Microwave Ablation System (Device)
Experimental: Patients with Malignant Liver Tumors
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.
Intervention: Microwave Ablation (Procedure)
Experimental: Patients with Malignant Liver Tumors
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.
Intervention: Ultrasound-CT fusion guidance system (Device)
Experimental: Patients with Malignant Liver Tumors
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.
Intervention: Local anesthesia and Conscious sedation (Drug)
Outcomes
Primary Outcomes
Technical success
Time Frame: 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
Time Frame: 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 Outcomes
- Recurrence-free survival(12 months after ablation)
- Complication after ablation(Immediately, 1 month, 3 months, 6 months, 9 months, and 12 months after radiofrequency ablation)
Investigators
Jeong Min Lee
Professor
Seoul National University Hospital