RecruitingNCT06960954

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.


Sponsor

Tanta University

Enrollment

116 participants

Start Date

Jan 15, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria6

  • 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.

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.


Locations(1)

Tanta University Hospitals

Tanta, Gharbyea, Egypt

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NCT06960954


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