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PIVKA-II for Predicting Portal Vein Thrombosis in Hepatocellular Carcinoma

Key facts

Where
Tanta, EgyptSee the site

Where in Egypt

  • Tanta University HospitalsTanta, EgyptTaking people

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Trial details

Who runs it
Tanta University
Trial code
NCT06960954
Record updated
7 May 2025
Original description
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.Read full original descriptionShow less

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

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).

Inclusion: 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: Prior locoregional therapy or liver transplantation; Patients with renal insufficiency; Patients with other malignancies; Patients on vitamin K, vitamin K antagonists or antibiotics; Patients with cholestasis; Unwilling to participate in our study.

ClinicalTrials.gov NCT06960954