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

NCT ID: NCT05361538

Last Updated: 2022-12-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-22
• Study Completion Date: 2025-06-01

Brief Summary

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.

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.

Conditions

Hepatocellular Cancer; Microwave Ablation; Microwave Spherical Ablation; Prognosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MTA Group

Use true circular microwave needle for ultrasound-guided thermal ablation in MSA （microwave spherical ablation） group.

Group Type: EXPERIMENTAL

True circular microwave needle

Intervention Type: DEVICE

Use true circular microwave needle for thermal ablation

MWA Group

Use normal microwave needle for ultrasound-guided thermal ablation in MTA （microwave ablation） group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

True circular microwave needle

Use true circular microwave needle for thermal ablation

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Third Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiang Jing

Role: STUDY_DIRECTOR

Tianjin Third Central Hospital

Locations

Tianjin Third Central Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiang Jing, MD

Role: CONTACT

Phone: 02284112323

Email: dr.jingxiang@aliyun.com

Yan Zhou, MD

Role: CONTACT

Phone: 02284118101

Email: zhouyan2626@163.com

Facility Contacts

Xiang Jing, MD

Role: primary

Yan Zhou, MD

Role: backup

Other Identifiers

drjingxiang005

Identifier Type: -

Identifier Source: org_study_id