PIVKA-II for Predicting Portal Vein Thrombosis in Hepatocellular Carcinoma

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    116
  • sponsor
    Tanta University
Updated on 8 May 2025

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).

Details
Condition Hepato Cellular Carcinoma (HCC), Portal Vein Tumour Thrombosis
Age 18years or above
Clinical Study IdentifierNCT06960954
SponsorTanta University
Last Modified on8 May 2025

Eligibility

Yes No Not Sure

Inclusion Criteria

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)

Exclusion Criteria

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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