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NCT Number: NCT06960954

PIVKA-II for Predicting Portal Vein Thrombosis in Hepatocellular Carcinoma

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).

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Key information

Conditions

Hepato Cellular Carcinoma (HCC) Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Portal Vein Tumour Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tanta University Hospitals

Tanta, Gharbyea, 31516, Egypt

Location status: Recruiting

Location contact

Dina H Ziada, MD, head of department

CONTACT

[email protected]

00201117109990

Madonna M Fahmy, MD

SUB_INVESTIGATOR

Nabila A Elgazzar, MD

PRINCIPAL_INVESTIGATOR

Rania M Elkafoury, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Diagnostic Test

Serum PIVKA-II level will be measured in HCC patients with and without PVTT.

Primary outcomes

PIVKA-II serum level for prediction of PVTT in HCC patients.

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nabila A Elgazzar, MD

CONTACT

[email protected]

00201288585733

Rania M Elkafoury, MD

CONTACT

[email protected]

+201004672358

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Prothrombin Induced by Vitamin K Absence II (PIVKA-II) Serum Level as a Predictor for Portal Vein Tumor Thrombosis in Hepatocellular Carcinoma Patients.

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: May 7, 2025
Registry last updated: May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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