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

Methodist Health System

Status: Enrolling

Conditions: Liver Diseases

Treatments: Procedure: Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT06336850

069.GID.2020.D

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Treatment

Experimental group

Description:

Patients undergoing Endoscopic-Ultrasound Guided liver biopsies and Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurements

Treatment:

Procedure: Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement