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

Primary Purpose

Portal Vein Thrombosis

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
EUS guided fine needle aspiration of portal vein thrombus
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Portal Vein Thrombosis focused on measuring EUS, FNA, PVT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • specialized medical hospital, Mansourah UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EUS - FNA for benign PVT by imaging

Arm Description

Intervention: Procedure/Surgery: EUS guided fine needle aspiration of portal vein thrombus

Outcomes

Primary Outcome Measures

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
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 )
Percentage of patients with portal vein thrombosis who underwent EUS guided FNA and had complications as a result of the invasive maneuver
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.

Secondary Outcome Measures

Full Information

First Posted
January 26, 2019
Last Updated
April 2, 2019
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT03902678
Brief Title
Role of EUS Guided FNA of Portal Vein Thrombus in the Diagnosis and Staging of Hepatocellular Carcinoma
Official Title
Role of Endoscopic Ultrasound Guided Fine Needle Aspiration of Portal Vein Thrombus in the Diagnosis and Staging of Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 11, 2017 (Actual)
Primary Completion Date
May 11, 2019 (Anticipated)
Study Completion Date
July 11, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
This is a pilot study that include 30 patients with liver cirrhosis and portal vein thrombus which don't fulfill the criteria of malignancy by imaging technique. The patients involved in the study were and will be admitted to Specialized Medical Hospital, Mansoura University Hospitals. Study end-points: • 24 months from the start of the research (cases will be collected over 18 months). Methods: Patients will be included in this study will be subjected to the following: І. The study will be explained to all participants in the study, and an informed written consent will be obtained from them before starting the study. ІІ. Medical history: Detailed history was taken with stress on: Signs of cachexia (unintentional weight loss, progressive muscle wasting, and a loss of appetite) Low grade fever Recent onset fatigue Abdominal pain Dyspepsia Hematemesis and melena Back ache ІІІ. Full clinical examination with special stress on: Vital signs including: pulse, arterial blood pressure, temperature, respiratory rate. Abdominal Lumps and/or tenderness IV. Laboratory investigations: Complete blood count, International Normalized Ratio, Liver enzymes, Serum albumin, Serum bilirubin and Serum creatinine. V. Radiology: Abdominal ultrasound for initial assessment, Abdominal CT (Contrast Enhanced) (Number of HCC nodules if present, diameter of largest HCC nodule in centimeters, nature of PVT, presence of abdominal metastases if present ), Non contrast CT chest to exclude pulmonary metastasis, Bone survey for indicated or complaining cases. VI. EUS-FNA: EUS-FNA will be performed in standard fashion. Under EUS guidance, the main, left and right portal veins will be identified. After verifying flow signal by Doppler, a 25-gauge EUS-FNA needle will be advanced from the duodenal bulb or second part of the duodenum into the portal vein, 1-2 passes through portal vein thrombus will be taken to ensure adequate cellularity for histopathology. The puncture site will be monitored under EUS for complications. Study outcomes: 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 ).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Portal Vein Thrombosis
Keywords
EUS, FNA, PVT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EUS - FNA for benign PVT by imaging
Arm Type
Experimental
Arm Description
Intervention: Procedure/Surgery: EUS guided fine needle aspiration of portal vein thrombus
Intervention Type
Procedure
Intervention Name(s)
EUS guided fine needle aspiration of portal vein thrombus
Intervention Description
endoscopic ultrasound guided fine needle aspiration of portal vein thrombus which did not fulfill criteria of malignancy by imaging technique
Primary Outcome Measure Information:
Title
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
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 )
Time Frame
3 days up to 2 weeks
Title
Percentage of patients with portal vein thrombosis who underwent EUS guided FNA and had complications as a result of the invasive maneuver
Description
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.
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dina S. Eskandere
Phone
01148979995
Email
dinaeskandere@mans.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmad Y. Altonbary, MD
Phone
01005100091
Email
Altonbary@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magdy H. Atwa, Professor
Organizational Affiliation
Faculty of Medicine, Mansoura University
Official's Role
Study Chair
Facility Information:
Facility Name
specialized medical hospital, Mansourah University
City
Mansourah
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
dina S. eskandere, Master
Phone
01148979995
Email
dinaeskandere@mans.edu.eg
First Name & Middle Initial & Last Name & Degree
Dina S. Eskandere, Master
First Name & Middle Initial & Last Name & Degree
Ahmad Y. Altonbary, MD
First Name & Middle Initial & Last Name & Degree
Hazem H. ElBeltagy, MD
First Name & Middle Initial & Last Name & Degree
Magdy H. Atwa, Professor

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20032150
Citation
Catalano 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.
Results Reference
background
PubMed Identifier
23364162
Citation
Handa 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.
Results Reference
background
PubMed Identifier
15044903
Citation
Lai 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.
Results Reference
background
PubMed Identifier
26327753
Citation
Tarantino 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.
Results Reference
background
PubMed Identifier
28320514
Citation
ASGE 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. Erratum In: Gastrointest Endosc. 2017 Jun;85(6):1312.
Results Reference
background
PubMed Identifier
26146089
Citation
Viechtbauer 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.
Results Reference
background
PubMed Identifier
26491529
Citation
Kayar 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.
Results Reference
result
PubMed Identifier
21475421
Citation
Michael H, Lenza C, Gupta M, Katz DS. Endoscopic Ultrasound -guided Fine-Needle Aspiration of a Portal Vein Thrombus to Aid in the Diagnosis and Staging of Hepatocellular Carcinoma. Gastroenterol Hepatol (N Y). 2011 Feb;7(2):124-9. No abstract available.
Results Reference
result
PubMed Identifier
27773725
Citation
Rustagi T, Gleeson FC, Chari ST, Abu Dayyeh BK, Farnell MB, Iyer PG, Kendrick ML, Pearson RK, Petersen BT, Rajan E, Topazian MD, Truty MJ, Vege SS, Wang KK, Levy MJ. Remote malignant intravascular thrombi: EUS-guided FNA diagnosis and impact on cancer staging. Gastrointest Endosc. 2017 Jul;86(1):150-155. doi: 10.1016/j.gie.2016.10.025. Epub 2016 Oct 20.
Results Reference
result
Links:
URL
http://www.pulmonarychronicles.com/index.php/pulmonarychronicles/article/view/496
Description
paper proved that benign portal vein thrombus by triphasic CT may be truly malignant by the histopathology but the researchers here used different inclusion and exclusion criteria. They obtained samples from cirrhotic patients only
URL
https://www.ajol.info/index.php/pamj/article/view/134058
Description
case study proved that benign portal vein thrombus by radiology is truly malignant by histopathology

Learn more about this trial

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

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