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Role of EUS Guided FNA of Portal Vein Thrombus in the Diagnosis and Staging of Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT03902678
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Mansoura University

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Portal Vein Thrombosis Procedure: EUS guided fine needle aspiration of portal vein thrombus Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Use of histopathology obtained from endoscopic ultrasound -fine needle aspiration of portal vein thrombus for identification of malignant thrombus which did not fulfill criteria of malignancy by abdominal ultrasound and triphasic abdominal CT
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Role of Endoscopic Ultrasound Guided Fine Needle Aspiration of Portal Vein Thrombus in the Diagnosis and Staging of Hepatocellular Carcinoma
Actual Study Start Date : May 11, 2017
Estimated Primary Completion Date : May 11, 2019
Estimated Study Completion Date : July 11, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EUS - FNA for benign PVT by imaging
Intervention: Procedure/Surgery: EUS guided fine needle aspiration of portal vein thrombus
Procedure: EUS guided fine needle aspiration of portal vein thrombus
endoscopic ultrasound guided fine needle aspiration of portal vein thrombus which did not fulfill criteria of malignancy by imaging technique




Primary Outcome Measures :
  1. 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 [ Time Frame: 3 days up to 2 weeks ]
    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 )

  2. Percentage of patients with portal vein thrombosis who underwent EUS guided FNA and had complications as a result of the invasive maneuver [ Time Frame: 2 days ]
    assessment of safety of the procedure ( The patients admitted and the new ones will be admitted to specialized medical hospital for 24 h after the procedure to exclude the possibility of bleeding at puncture site, risk of biliary peritonitis, and extravasation from the site of the thrombus.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902678


Contacts
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Contact: Dina S. Eskandere 01148979995 dinaeskandere@mans.edu.eg
Contact: Ahmad Y. Altonbary, MD 01005100091 Altonbary@gmail.com

Locations
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Egypt
specialized medical hospital, Mansourah University Recruiting
Mansourah, Dakahlia, Egypt, 35516
Contact: dina S. eskandere, Master    01148979995    dinaeskandere@mans.edu.eg   
Principal Investigator: Dina S. Eskandere, Master         
Sub-Investigator: Ahmad Y. Altonbary, MD         
Sub-Investigator: Hazem H. ElBeltagy, MD         
Sub-Investigator: Magdy H. Atwa, Professor         
Sponsors and Collaborators
Mansoura University
Investigators
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Study Chair: Magdy H. Atwa, Professor Faculty of Medicine, Mansoura University
  Study Documents (Full-Text)

Documents provided by Mansoura University:
Study Protocol  [PDF] March 7, 2019


Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT03902678     History of Changes
Other Study ID Numbers: MD /17.06.69
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mansoura University:
EUS
FNA
PVT

Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Thrombosis
Venous Thrombosis
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases