PIVKA-II for Predicting Portal Vein Thrombosis in Hepatocellular Carcinoma
- Conditions
- Hepato Cellular Carcinoma (HCC)Portal Vein Tumour Thrombosis
- Registration Number
- NCT06960954
- Lead Sponsor
- Tanta University
- Brief Summary
The goal of this cross-sectional observational study is to evaluate the relation between Prothrombin induced by vitamin K absence II (PIVKA-II) and the presence of portal vein tumor thrombosis (PVTT) in hepatocellular carcinoma (HCC) patients.
Researchers will compare PIVKA-II serum levels in HCC patients with PVTT and without PVTT.
Participants will undergo history-taking, clinical examination, laboratory investigations, PIVKA-II serum level, Child-Pugh classification, Model for End-stage Liver Disease (MELD) score, BCLC staging, abdominal ultrasonography, and Triphasic CT abdomen with contrast or MRI to evaluate tumor site, size, number, and presence of PVTT (a filling defect in the portal vein or its branch to distinguish PVTT or thrombus).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 116
- Male or female patients older than 18 years.
- Patients with confirmed HCC with or without PVTT (Diagnosed by two imaging modalities or one imaging modality with elevated serum alpha fetoprotein or liver biopsy).
- Prior locoregional therapy or liver transplantation.
- Patients on vitamin K, vitamin K antagonists or antibiotics.
- Patients with cholestasis.
- Patients with renal insufficiency.
- Patients with other malignancies.
- Unwilling to participate in our study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PIVKA-II serum level for prediction of PVTT in HCC patients. through study completion, an average of 1 year PIVKA-II level (mAU/mL) will be measured in serum of HCC patients with and without PVTT.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Tanta University Hospitals
🇪🇬Tanta, Gharbyea, Egypt