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

NCT03902678 | Unknown

• 1 other identifier: MD /17.06.69
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Portal Vein Thrombosis

Keywords

EUS; FNA; PVT

Outcome Measures

Primary Outcomes (2)

• 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 )

  3 days up to 2 weeks

• 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.

  2 days

Study Arms (1)

EUS - FNA for benign PVT by imaging

EXPERIMENTAL

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

Procedure: EUS guided fine needle aspiration of portal vein thrombus

Interventions

EUS guided fine needle aspiration of portal vein thrombus PROCEDURE

endoscopic ultrasound guided fine needle aspiration of portal vein thrombus which did not fulfill criteria of malignancy by imaging technique

EUS - FNA for benign PVT by imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

specialized medical hospital, Mansourah University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

RECRUITING

Related Publications (9)

• 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.

  PMID: 20032150 BACKGROUND

• 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.

  PMID: 23364162 BACKGROUND

• 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.

  PMID: 15044903 BACKGROUND

• 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.

  PMID: 26327753 BACKGROUND

• 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.

  PMID: 28320514 BACKGROUND

• 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.

  PMID: 26146089 BACKGROUND

• 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.

  PMID: 26491529 RESULT

• 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.

  PMID: 21475421 RESULT

• 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.

  PMID: 27773725 RESULT

Related Links

• 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

Study Officials

• Magdy H. Atwa, Professor

  Faculty of Medicine, Mansoura University

  STUDY CHAIR

Central Study Contacts

Dina S. Eskandere

CONTACT

01148979995; dinaeskandere@mans.edu.eg

Ahmad Y. Altonbary, MD

CONTACT

01005100091; Altonbary@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 26, 2019
• First Posted: April 4, 2019
• Study Start: May 11, 2017
• Primary Completion: May 11, 2019
• Study Completion: July 11, 2019
• Last Updated: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)