PIVKA-II for Predicting Portal Vein Thrombosis in Hepatocellular Carcinoma

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06960954

Enrollment

116

Registered

2025-05-07

Start date

2025-01-15

Completion date

2025-12-31

Last updated

2025-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepato Cellular Carcinoma (HCC), Portal Vein Tumour Thrombosis

Keywords

PIVKA-II, Portal vein tumor thrombosis, Hepatocellular carcinoma

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).

Interventions

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

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

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Egypt

Contacts

Primary ContactRania M Elkafoury, MD

rania.elkafoury@med.tanta.edu.eg+201004672358

Backup ContactNabila A Elgazzar, MD

nabilaelgazzar@med.tanta.edu.eg00201288585733

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026