Clinical trial · Observational
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepato Cellular Carcinoma (HCC) | — | UNRESOLVED | — |
| Portal Vein Tumour Thrombosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prothrombin induced by vitamin K absence II (PIVKA-II) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- HCC patients with PVTT.
- description
- 58 HCC patients with PVTT.
- interventionNames
- Diagnostic Test: Prothrombin induced by vitamin K absence II (PIVKA-II)
- label
- HCC Patients without PVTT.
- description
- 58 HCC Patients without PVTT.
- interventionNames
- Diagnostic Test: Prothrombin induced by vitamin K absence II (PIVKA-II)
Primary outcomes (1)
- measure
- PIVKA-II serum level for prediction of PVTT in HCC patients.
- timeFrame
- through study completion, an average of 1 year
- description
- PIVKA-II level (mAU/mL) will be measured in serum of HCC patients with and without PVTT.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available