Skip to main content
OpenTrials
Completed

NCT Number: NCT06336850

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Liver Diseases Digestive System Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endoscopic ultrasound-guided portal pressure gradient measurement

Procedure

The endoscopic ultrasound (EUS)-guided 25G fine needle aspirate (FNA) needle procedure is a straightforward minimally invasive technique for direct portal pressure measurements.

Primary outcomes

  1. Portal Pressure Gradient Measurements from Hepatic and Portal Veins

    Time frame: 2 years

    A catheter is inserted into the hepatic vein before hepatic venous pressure and portal vein pressure are recorded

Secondary outcomes

  1. Correlation between Portal Pressure Gradient Measurements and the presence or absence of portal hypertension

    Time frame: 2 years

    Statistical tests to determine relationship between portal pressure gradient measurements and portal hypertension

  2. Clinical significance between portal pressure gradient measurement and portal hypertension

    Time frame: 2 years

    Presence of varices, hypertensive gastropathy, or thrombocytopenia.

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 29, 2024
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.