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

March 26, 2024 updated by: Methodist Health System
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75203
        • Recruiting
        • Methodist Dallas Medical Center
        • Contact:
          • Prashant Kedia, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Patients undergoing Endoscopic-Ultrasound Guided liver biopsies and Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurements
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
Clinical significance between portal pressure gradient measurement and portal hypertension
Time Frame: 2 years
Presence of varices, hypertensive gastropathy, or thrombocytopenia.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Methodist Health System

Investigators

  • Principal Investigator: Prashant Kedia, MD, Methodist Dallas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2020

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

December 9, 2021

First Submitted That Met QC Criteria

March 26, 2024

First Posted (Actual)

March 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 069.GID.2020.D

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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