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Recruiting Observational

PIVKA-II for Predicting Portal Vein Thrombosis in Hepatocellular Carcinoma

NCT06960954 · tracked via the Priya Life Science Egypt tracker
Phase
Observational
Started
2025-01-15
Last updated
2025-05-07

Condition(s) studied

Hepato Cellular Carcinoma (HCC)Portal Vein Tumour Thrombosis

Investigational drug(s) / intervention(s)

Prothrombin induced by vitamin K absence II (PIVKA-II)

Prothrombin induced by vitamin K absence II (PIVKA-II): Serum PIVKA-II level will be measured in HCC patients with and without PVTT.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Tanta University Hospitals Tanta Gharbyea Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06960954 on ClinicalTrials.gov ↗ ← All trials in Egypt