Safety and Efficacy of Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement

Liver Diseases Clinical Trial

Official title:

Safety and Efficacy of Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06336850
• Other study ID #: 069.GID.2020.D
• Status: Recruiting
• Phase: N/A
• Start date: December 23, 2020
• Est. completion date: January 1, 2025

Study information

• Verified date: March 2024
• Source: Methodist Health System
• Contact: Crystee Cooper, DHEd
• Phone: 214-947-1280
• Email: clinicalresearch[@]mhd.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy, safety, and adequacy of Endoscopic Ultrasound (EUS) Portal Pressure Gradient Measurement (PPGM) in patients undergoing EUS-guided liver biopsies.

Description:

Patients undergoing EUS-guided liver biopsy may qualify to participate in this study. The purpose of this study is to evaluate the efficacy, safety, and adequacy of EUS- Portal Pressure Gradient Measurement (PPGM) in patients with liver disease referred for EUS-guided liver biopsy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

INCLUSION CRITERIA

• Age 18 years or older
• Patient who has been referred for EUS procedure and direct PPG measurement and -undergoing EUS-guided liver biopsy
• History of liver disease or suspected cirrhosis and considered for PPGM EXCLUSION CRITERIA
• Patient is less than 18 or greater than 85 years of age
• Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study
• Patient is unwilling or unable to sign and date the informed consent
• Patient for whom endoscopic procedures are contraindicated.

Related Conditions & MeSH terms

• Liver Diseases

Intervention

Procedure:
• Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement
The endoscopic ultrasound (EUS)-guided 25G fine needle aspirate (FNA) needle procedure is a straightforward minimally invasive technique for direct portal pressure measurements.

Locations

Country	Name	City	State
United States	Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Portal Pressure Gradient Measurements from Hepatic and Portal Veins	A catheter is inserted into the hepatic vein before hepatic venous pressure and portal vein pressure are recorded	2 years
Secondary	Correlation between Portal Pressure Gradient Measurements and the presence or absence of portal hypertension	Statistical tests to determine relationship between portal pressure gradient measurements and portal hypertension	2 years
Secondary	Clinical significance between portal pressure gradient measurement and portal hypertension	Presence of varices, hypertensive gastropathy, or thrombocytopenia.	2 years