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
Qualifiers
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 design
Treatments tested in this trial
- Prothrombin induced by vitamin K absence II (PIVKA-II)
Treatment groups
116 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov