NCT06336850

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 23, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 29, 2024

Completed
Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

2.8 years

First QC Date

December 9, 2021

Last Update Submit

June 8, 2026

Conditions

Liver Diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

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

    2 years

  • Clinical significance between portal pressure gradient measurement and portal hypertension

    2 years

Study Arms (1)

Treatment

EXPERIMENTAL

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

Procedure: Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement

Interventions

Endoscopic Ultrasound-Guided Portal Pressure Gradient MeasurementPROCEDURE

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

Treatment

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Prashant Kedia, MD

    The Methodist Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2021

First Posted

March 29, 2024

Study Start

December 23, 2020

Primary Completion

October 17, 2023

Study Completion

October 17, 2023

Last Updated

June 10, 2026

Record last verified: 2026-06

Locations

US(1)