Patients aged eighteen years or older with intermediate-stage HCC were eligible for enrollment if they were deemed suitable for and undergoing their first TACE treatment. HCC, Intermediate stage, PIVKA, monitoring, predict, response
Conditions
Interventions
Serum PIVKA-II and Radiological Response Definitions: The serum PIVKA-II response was calculated as the percentage reduction from the baseline level (measured the day prior to the TACE procedure) comp
Experimental Other
PIVKA monitoring
Sponsors
Faculty of Medicine, Khon Kaen University
Gastroenterological Association of Thailand (GAT),Roche Diagnostics (Thailand) Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Patients aged eighteen years or older with intermediate-stage HCC receiving the first TACE
Exclusion criteria
Exclusion criteria: 1. Prior treatment for HCC, including liver resection, ablation, percutaneous ethanol injection, systemic therapy, or other HCC-specific treatments. 2. Contraindications to TACE. 3. A history of liver resection, other liver surgery, or liver transplantation. 4. Baseline serum PIVKA-II levels less than 23.6 ng/mL (defined as normal or below the established cutoff for HCC). 5. Documented vitamin K deficiency or current use of warfarin or anticoagulants affecting vitamin K metabolism. 6. Inability or unwillingness to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to determine the diagnostic performance and optimal cut-off value of the percentage reduction in PIVKA-II levels at 2 weeks following the first TACE in predicting CR in HCC 2 week and 8 week after TACE Diagnostic study | — |
Secondary
| Measure | Time frame |
|---|---|
| determining the optimal cut-off value and diagnostic accuracy of the PIVKA-II response at 8 weeks post-TACE 8 week after TACE Diagnostic study | — |
Countries
Thailand
Contacts
Public ContactChitchai Rattananukrom
Khon Kaen University
Outcome results
None listed