Study of Microwave Spherical Ablation and Traditional Microwave Ablation in Single Hepatocellular Carcinoma ≤5cm

A Single-center, Prospective Randomized Controlled Study of Microwave Spherical Ablation and Traditional Microwave Ablation in the Treatment of Single Hepatocellular Carcinoma With a Diameter of ≤5cm

Comparison of the progression-free survival, overall survival, local progression rates, complete ablation rates and the complications rate of MSA and traditional MWA in the treatment of single hepatocellular carcinoma with a diameter of ≤5cm.

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Cancer; Prognosis; Microwave Ablation; Microwave Spherical Ablation
• Intervention / Treatment: Device: True circular microwave needle

Detailed Description

HCC is a serious threat to the health of people，Early treatment of HCC results in a good prognosis for patients. Microwave ablation (MWA) is an important method for the treatment of early HCC. The traditional MWA technology has a long diameter of the ablation foci which is much larger than the transverse diameter, so in order to obtain a sufficient transverse diameter, the long diameter is often too large beyond the tumor boundary. That will cause too much normal liver tissue is unnecessarily damaged, especially for patients with severe liver cirrhosis or patients with liver cirrhosis who have undergone liver resection. In addition, it is easy to cause damage to adjacent vital tissues and organs. Changes in tissue properties during ablation affect the stability of the microwave field, resulting in unpredictable ablation shapes, which may cause omissions during tumor ablation, especially in multiple overlapping ablation, resulting in incomplete ablation, or increasing the risk of local tumor progression after treatment. Microwave spherical ablation (MSA) technology is a new MWA technology. With the help of temperature control technology, field control technology and wave control technology, a single needle can produce predictable spherical ablation lesions. Theoretically, MSA can improve the controllability of the ablation foci, which is suitable for the purpose of conformal ablation of large tumors in clinical practice, thereby minimizing the damage of local thermal ablation to liver tissue and adjacent important organs. However, there are few reports on the comparison of the therapeutic effect of MSA and traditional MWA. This study intends to conduct a prospective randomized controlled study based on the two mature microwave treatment methods of MSA and traditional MWA ablation to explore the effectiveness and safety of MSA in clinical application, providing evidence-based medical evidence for the clinical application of MSA.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiang Jing, MD; Phone Number: 02284112323; Email: dr.jingxiang@aliyun.com
• Study Contact Backup: Name: Yan Zhou, MD; Phone Number: 02284118101; Email: zhouyan2626@163.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300170
      • Recruiting
      • Tianjin Third Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient has high risk factors for HCC and was first diagnosed of HCC by by contrast-enhanced imaging (CECT/CEMRI/CEUS) and/or pathology ;
2. Age range 18 to 75 years old;
3. Single lesion with tumor diameter ≤5cm;
4. Patient refuses surgery and determines to undergo microwave ablation
5. Liver function Child Pugh A or B;
6. No extrahepatic metastasis or portal invasion;
7. Patient signs the informed consent.

Exclusion Criteria:

1. The lesion has received treatment, including local ablation therapy and TACE therapy, etc;
2. With portal vein invasion or extrahepatic metastases;
3. Patient is with severe cardiopulmonary insufficiency.
4. Patient is a pregnant or breastfeeding women.
5. Patient is considered to be unsuitable to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MTA Group; Use true circular microwave needle for ultrasound-guided thermal ablation in MSA （microwave spherical ablation） group.	Device: True circular microwave needle; Use true circular microwave needle for thermal ablation
No Intervention: MWA Group; Use normal microwave needle for ultrasound-guided thermal ablation in MTA （microwave ablation） group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of progression-free survival between MSA and traditional MWA in HCC	Compare the time to tumor progression after therapy of MSA and traditional MWA in the treatment of single hepatocellular carcinoma with a diameter of ≤5 cm	6 to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the overall survival of MSA and traditional MWA in HCC	Compare the time to of all-cause mortality after therapy of MSA and traditional MWA in the treatment of single hepatocellular carcinoma with a diameter of ≤5cm	12 to 60 months
Comparison of local progression rates of MSA and traditional MWA in HCC	Local progression was defined as new lesions with hyperenhancement in the arterial phase and low enhancement in the portal or delayed phase found adjacent to the ablation lesion (≤5 mm) during follow-up. Compare the local progression rates after therapy of MTA and traditional MWA in the treatment of single hepatocellular carcinoma with a diameter of ≤ 5 cm	6 to 12 months
Comparison of complete ablation rates of MSA and traditional MWA in HCC	Complete ablation was defined as the tumor showing no enhancement in three stages on contrast-enhanced imaging. Compare the rate of complete ablation after therapy of MTA and traditional MWA in the treatment of single hepatocellular carcinoma with a diameter of ≤5 cm	1 month
Comparison of the complications rate of MSA and traditional MWA in HCC	Compare the rate of the complications during and after the therapy of MSA and traditional MWA in the treatment of patients with single hepatocellular carcinoma with a diameter of ≤5cm	immediately

Collaborators and Investigators

• Sponsor: Tianjin Third Central Hospital
• Investigators: Study Director: Xiang Jing, Tianjin Third Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: April 29, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Estimate): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 11, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Carcinoma, Hepatocellular; Liver Neoplasms
• Other Study ID Numbers: drjingxiang005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No