Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements vs. Transjugular Balloon Occlusion Measurement: A Multicenter EU Study

Withdrawn

• Conditions: liver cirrhosis, portal hypertension; increased venous liver pressure; scarring of the liver; 10019654

• Registration Number: NL-OMON56366
• Lead Sponsor: Cook Research Incorporated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 9

Inclusion Criteria

Patients with cirrhosis who have been referred for a procedure where HVPG is
obtained.

Exclusion Criteria

General criteria:
1. Patient is < 18 or > 85 years of age
2. Patient is pregnant, breast-feeding, or planning to become pregnant during
the
course of the study
3. Patient is unwilling or unable to sign and date the informed consent
4. Patient is unwilling to comply with the follow-up study schedule
5. Patient for whom endoscopic procedures are contraindicated
6. Patients for whom propofol general anesthesia is contraindicated

Medical criteria:
7. Platelet count <50,000 per mm3
8. International normalized ratio (INR) > 1.7
9. Estimated glomerular filtration rate (eGFR) (see Definitions section) < 50
mL/min/1.73m2
10. Previous transjugular intrahepatic or surgical portosystemic shunt
11. Previous total or partial splenectomy
12. Non-cirrhotic portal hypertension
13. Known history of spontaneous bacterial peritonitis (SBP) within the last
three months irrespective of treatment for SBP
14. Patients with known infection which is not controlled by medical
intervention
15. Portopulmonary hypertension
16. Cardiac decompensation
17. Pre-sinusoidal liver disease
18. Cholestatic liver disease
19. Patient who received endoscopic treatment for upper gastrointestinal (GI)
variceal bleeding within the past 7 days
20. Patients with current hepatocellular carcinoma (HCC)

Anatomical (identified at screening and/or during the endoscopic procedure)
criteria:
21. Portal vein thrombosis
22. Anatomic abnormalities of the hepatic vasculature that prevent access to
the intrahepatic
portion of the portal vein or hepatic veins
23. Evidence of active GI bleeding
24. If the volume of ascites in the path of the needle prevents apposition of
the gastrointestinal
tract and liver

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary measure is the evaluation of the correlation between the calculated<br /><br>PPG obtained using the EchoTip® Insight and the HVPG procedure performed under<br /><br>general anesthesia.</p><br>