PIVKA-II for Predicting Portal Vein Thrombosis in Hepatocellular Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prothrombin induced by vitamin K absence II (PIVKA-II).
- Who it may be relevant to
- Registry conditions: Hepato Cellular Carcinoma (HCC), Portal Vein Tumour Thrombosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prothrombin Induced by Vitamin K Absence II (PIVKA-II) Serum Level as a Predictor for Portal Vein Tumor Thrombosis in Hepatocellular Carcinoma Patients.
Overview
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 test Prothrombin induced by vitamin K absence II (PIVKA-II)
Serum PIVKA-II level will be measured in HCC patients with and without PVTT.
Primary outcome measures
- PIVKA-II serum level for prediction of PVTT in HCC patients. [Time frame: through study completion, an average of 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Ecologic or community
Study locations
Egypt · 1 center
- Tanta University Hospitals — Tanta
Identifiers
NCT: NCT06960954 · 36264PR1127/3/25