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

NCT ID: NCT06336850

Last Updated: 2024-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-23

Study Completion Date

2025-01-01

Brief Summary

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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

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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.

Conditions

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Liver Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Treatment

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

Group Type EXPERIMENTAL

Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Methodist Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prashant Kedia, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

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Methodist Dallas Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Crystee Cooper, DHEd

Role: CONTACT

214-947-1280

Zaid Haddadin, MS

Role: CONTACT

214-947-1280

Facility Contacts

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Prashant Kedia, MD

Role: primary

Other Identifiers

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069.GID.2020.D

Identifier Type: -

Identifier Source: org_study_id

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