PIVKA-II for Predicting Portal Vein Thrombosis in Hepatocellular Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTanta University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Prior locoregional therapy or liver transplantation.
Patients on vitamin K, vitamin K antagonists or antibiotics.
Patients with cholestasis.
Patients with renal insufficiency.
Trial population
This cross-sectional study will be carried out on 116 patients attending the Tanta Tropical Medicine Outpatient Clinic, Faculty of Medicine. The start of the research will be in January 2025 to December 2025 or until the collection of the cases.
Trial design
Design model
Ecologic or community
Time perspective
Cross-sectional
Treatments tested in this trial
Prothrombin induced by vitamin K absence II (PIVKA-II)
Diagnostic testSerum PIVKA-II level will be measured in HCC patients with and without PVTT.
Treatment groups
116 Participants
are divided into 2 treatment groupsGroup A: HCC patients with PVTT.1 intervention
Group B: HCC Patients without PVTT.1 intervention
Trial outcomes
Primary outcomes
1
PIVKA-II serum level for prediction of PVTT in HCC patients.
PIVKA-II level (mAU/mL) will be measured in serum of HCC patients with and without PVTT.
Time frame
through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov