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

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

Study Overview

• Status: Recruiting
• Conditions: HCC; Recurrence Tumor

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients who underwent thermal ablation of HCC will be observed and evaluate the predictive power of combined elastography for tumor recurrence.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): May 31, 2024

Study Registration Dates

• First Submitted: November 10, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 23, 2020

Study Record Updates

• Last Update Posted (Actual): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Ultrasound; Recurrence; Thermal ablation; Elastography; Predictive Cancer Model
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: S2020-387-03

Drug and device information, study documents

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