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

HCC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04640363
• Other study ID #: S2020-387-03
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: May 31, 2024

Study information

• Verified date: January 2021
• Source: Chinese PLA General Hospital
• Contact: Jie Yu, Doctor
• Phone: 010-66937981
• Email: yu-jie301[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• HCC
• Recurrence
• Recurrence Tumor

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	F index	F index is linked to the degree of liver fibrosis,and it can be available by ultrasound elastography checking.	baseline
Primary	A index	A index is linked to the degree of hepatitis,and it can be available by ultrasound elastography checking.	baseline
Primary	ATT index	ATT index is linked to the degree of steatosis of liver,and it can be available by ultrasound elastography checking.	baseline
Primary	Spleen stiffness	Spleen stiffness can be available by ultrasound elastography checking.	baseline