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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06336850

Enrollment

100

Registered

2024-03-29

Start date

2020-12-23

Completion date

2023-10-17

Last updated

2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Diseases

Brief 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.

Detailed 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.

Interventions

PROCEDUREEndoscopic 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Portal Pressure Gradient Measurements from Hepatic and Portal Veins	2 years	A catheter is inserted into the hepatic vein before hepatic venous pressure and portal vein pressure are recorded

Secondary

Measure	Time frame	Description
Correlation between Portal Pressure Gradient Measurements and the presence or absence of portal hypertension	2 years	Statistical tests to determine relationship between portal pressure gradient measurements and portal hypertension
Clinical significance between portal pressure gradient measurement and portal hypertension	2 years	Presence of varices, hypertensive gastropathy, or thrombocytopenia.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORPrashant Kedia, MD

The Methodist Hospital Research Institute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026