Combi-elastography Assessment of HCC Recurrence After Thermal Ablation Multi-center Study

• Conditions: Recurrence Tumor; HCC

• Registration Number: NCT04640363
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

Combined F index, A index,ATT index and spleen stiffness to predict tumor recurrence in different liver settings after thermal ablation of HCC.

Detailed Description

Thermal ablation is one of the established method for HCC treatment. Postoperative recurrence of HCC is one of the major factors leading to poor prognosis of HCC patients. Most studies have shown that the risk factors of recurrence include tumor size, tumor number and intrahepatic spread, etc.

Besides, the carcinogenic effects of inflammatory activity and fibrosis in liver background caused by chronic hepatitis also be related to the recurrence. In the study, combi-elastography imaging technology , not only the F index which is related to liver fibrosis stage can be obtained, but also the A index which is related to inflammation activity can be measured, this may provide a more valuable method for tumor recurrence of early prediction.

Study Timeline

• Study First Submitted: 2020-11-10
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-23
• Study Start: 2020-12-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-01-15
• Primary Completion: 2023-12-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Aged 18 to 80 years of age, and gender not limited;Chronic hepatitis B patients;The lesions of liver have the histopathological diagnosis of HCC and within MiLan criteria;All lesions were performed thermal ablation surgery;Sign the informed consent.

Exclusion Criteria

• Lesions that unrealized complete inactivation evaluation by the enhanced imaging;Merging other systems' serious illness that can't cooperate with elastic imaging checking(such as heart failure, renal failure, such as mental illness);After liver transplantation patients;Patients with pregnancy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A index	baseline	A index is linked to the degree of hepatitis,and it can be available by ultrasound elastography checking.
F index	baseline	F index is linked to the degree of liver fibrosis,and it can be available by ultrasound elastography checking.
ATT index	baseline	ATT index is linked to the degree of steatosis of liver,and it can be available by ultrasound elastography checking.
Spleen stiffness	baseline	Spleen stiffness can be available by ultrasound elastography checking.

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China