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

NCT05361538 | Unknown

• 1 other identifier: drjingxiang005
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Cancer; Microwave Ablation; Microwave Spherical Ablation; Prognosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Comparison of the overall survival of MSA and traditional MWA in HCC

  12 to 60 months

• Comparison of local progression rates of MSA and traditional MWA in HCC

  6 to 12 months

• Comparison of complete ablation rates of MSA and traditional MWA in HCC

  1 month

• Comparison of the complications rate of MSA and traditional MWA in HCC

  immediately

Study Arms (2)

MTA Group

EXPERIMENTAL

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

Device: True circular microwave needle

MWA Group

NO INTERVENTION

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

Interventions

True circular microwave needle DEVICE

Use true circular microwave needle for thermal ablation

MTA Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tianjin Third Central Hospital: lead

Study Sites (1)

Tianjin Third Central Hospital

Tianjin, Tianjin Municipality, 300170, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Xiang Jing

  Tianjin Third Central Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiang Jing, MD

CONTACT

02284112323; dr.jingxiang@aliyun.com

Yan Zhou, MD

CONTACT

02284118101; zhouyan2626@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 4, 2022
• Study Start: June 22, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2025
• Last Updated: December 14, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)