Clinical trial · Interventional
Role of EUS Guided FNA of Portal Vein Thrombus in the Diagnosis and Staging of Hepatocellular Carcinoma
Role of Endoscopic Ultrasound Guided Fine Needle Aspiration of Portal Vein Thrombus in the Diagnosis and Staging of Hepatocellular Carcinoma
- 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)
Since not every portal vein thrombus (PVT) in a patient with hepatocellular carcinoma (HCC) is a tumor thrombus, since the nature of the thrombus will ultimately determine the course of treatment, and since PVT may be even the initial sign of an undetected HCC, every effort should be made to distinguish between a tumor and a non-tumor PVT. In addition, malignant PVT does not always demonstrate neovascularity and/or enhancement, which makes fine needle aspiration (FNA) necessary in order to characterize the nature of the PVT. Sampling of portal vein thrombus with trans-abdominal ultrasound guidance may lead to erroneous results because of inadvertent inclusion of normal hepatocytes or associated liver masses. Further, potential adverse events of trans-abdominal portal vein sampling include serious biliary and/or vascular injury. In contrast to the percutaneous approach, Endoscopic ultrasound (EUS) provides a unique view and access to the main portal vein. From the duodenal bulb and second part of the duodenum, the portal vein can be visualized from the confluence of the splenic and superior mesenteric veins into the porta hepatis. Periportal collateral vessels or cavernous transformation of the portal vein, which commonly are associated with portal vein thrombosis, are also easily and reliably detected by EUS instruments with color Doppler US capability. With a linear-array echo-endoscope, the portal vein can be punctured easily with a fine needle under direct visualization, while avoiding the adjacent hepatic artery, bile duct, and collateral vessels (if present). Because the approach is not trans-hepatic, it eliminates any need to avoid the primary tumor and any possibility of contaminating the specimen with hepatocytes, as can occur if the needle tracks through the liver parenchyma. Thus, the rate of false-positive diagnoses is likely to be lower with the EUS compared with the percutaneous approach
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Portal Vein Thrombosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUS guided fine needle aspiration of portal vein thrombus | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EUS - FNA for benign PVT by imaging
- description
- Intervention: Procedure/Surgery: EUS guided fine needle aspiration of portal vein thrombus
- interventionNames
- Procedure: EUS guided fine needle aspiration of portal vein thrombus
Primary outcomes (2)
- measure
- Percentage of patients with bland portal vein thrombosis diagnosed by triphasic abdominal CT who are proven to have malignant cells by histopathology obtained via EUS-guided FNA
- timeFrame
- 3 days up to 2 weeks
- description
- Histopathology of biopsies taken from bland portal vein thrombus which diagnosed by triphasic CT abdomen to evaluate the possibility of malignant PVT that was not discovered by imaging technique (Abdominal ultrasound and triphasic abdominal CT )
- measure
- Percentage of patients with portal vein thrombosis who underwent EUS guided FNA and had complications as a result of the invasive maneuver
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with liver cirrhosis and PVT which don't fulfill criteria of malignancy by triphasic CT abdomen defined as, (neovascularity of thrombus, arterial enhancement with rapid washout, direct invasion by adjacent hepatic mass and diameter of thrombus more than 23 mm), either : * With or without hepatic mass * Undergone local treatment or surgical treatment following a diagnosis of HCC and develop PVT during their follow up. Exclusion Criteria: * Uncooperative or excessively apprehensive patient * Anticoagulation treatment or non-substituted coagulopathy (International Normalized Ratio ≥ 1.5, Platelet count ≤ 50.000 cells/mm3, heparin administration at therapeutic doses). * Inhibition of platelet aggregation by clopidogrel and other thienopyridines. * Contraindications of sedation (Uncontrolled Diabetes Mellitus, Uncontrolled Thyroid Disorders, Pregnancy, Respiratory Embarrassment, Reactional Drugs like Antidepressants and Anti-anxiety Agents). * Patients fulfilling criteria of malignancy by triphasic CT on abdomen. * Extra hepatic metastasis of HCC. * Child-Pugh classification stage C.
References
Publications (9)
- BACKGROUNDCatalano OA, Choy G, Zhu A, Hahn PF, Sahani DV. Differentiation of malignant thrombus from bland thrombus of the portal vein in patients with hepatocellular carcinoma: application of diffusion-weighted MR imaging. Radiology. 2010 Jan;254(1):154-62. doi: 10.1148/radiol.09090304. PMID 20032150
- BACKGROUNDHanda P, Crowther M, Douketis JD. Portal vein thrombosis: a clinician-oriented and practical review. Clin Appl Thromb Hemost. 2014 Jul;20(5):498-506. doi: 10.1177/1076029612473515. Epub 2013 Jan 29. PMID 23364162
- BACKGROUNDLai R, Stephens V, Bardales R. Diagnosis and staging of hepatocellular carcinoma by EUS-FNA of a portal vein thrombus. Gastrointest Endosc. 2004 Apr;59(4):574-7. doi: 10.1016/s0016-5107(04)00007-0. No abstract available. PMID 15044903
- BACKGROUNDTarantino L, Ambrosino P, Di Minno MN. Contrast-enhanced ultrasound in differentiating malignant from benign portal vein thrombosis in hepatocellular carcinoma. World J Gastroenterol. 2015 Aug 28;21(32):9457-60. doi: 10.3748/wjg.v21.i32.9457. PMID 26327753
- BACKGROUNDASGE Technology Committee; Trikudanathan G, Pannala R, Bhutani MS, Melson J, Navaneethan U, Parsi MA, Thosani N, Trindade AJ, Watson RR, Maple JT. EUS-guided portal vein interventions. Gastrointest Endosc. 2017 May;85(5):883-888. doi: 10.1016/j.gie.2017.02.019. Epub 2017 Mar 18. No abstract available. PMID 28320514
- BACKGROUNDViechtbauer W, Smits L, Kotz D, Bude L, Spigt M, Serroyen J, Crutzen R. A simple formula for the calculation of sample size in pilot studies. J Clin Epidemiol. 2015 Nov;68(11):1375-9. doi: 10.1016/j.jclinepi.2015.04.014. Epub 2015 Jun 6. PMID 26146089
- RESULTKayar Y, Turkdogan KA, Baysal B, Unver N, Danalioglu A, Senturk H. EUS-guided FNA of a portal vein thrombus in hepatocellular carcinoma. Pan Afr Med J. 2015 Jun 3;21:86. doi: 10.11604/pamj.2015.21.86.6991. eCollection 2015.