PIVKA-II for Predicting Portal Vein Thrombosis in Hepatocellular Carcinoma

NCT ID: NCT06960954

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-15

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Hepato Cellular Carcinoma (HCC) Portal Vein Tumour Thrombosis

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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HCC patients with PVTT.

58 HCC patients with PVTT.

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

Intervention Type DIAGNOSTIC_TEST

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

HCC Patients without PVTT.

58 HCC Patients without PVTT.

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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Rania Mamdouh Elkafoury

Lecturer of Tropical medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rania M Elkafoury, MD

Role: STUDY_DIRECTOR

Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University

Locations

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Tanta University Hospitals

Tanta, Gharbyea, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Rania M Elkafoury, MD

Role: CONTACT

+201004672358

Nabila A Elgazzar, MD

Role: CONTACT

00201288585733

Facility Contacts

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Dina H Ziada, MD, head of department

Role: primary

00201117109990

Other Identifiers

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36264PR1127/3/25

Identifier Type: -

Identifier Source: org_study_id

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