Safety and Efficacy of Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement
1 other identifier
interventional
100
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 23, 2020
CompletedFirst Submitted
Initial submission to the registry
December 9, 2021
CompletedFirst Posted
Study publicly available on registry
March 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedMarch 29, 2024
March 1, 2024
4 years
December 9, 2021
March 26, 2024
Conditions
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
EXPERIMENTALPatients undergoing Endoscopic-Ultrasound Guided liver biopsies and Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurements
Interventions
The endoscopic ultrasound (EUS)-guided 25G fine needle aspirate (FNA) needle procedure is a straightforward minimally invasive technique for direct portal pressure measurements.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prashant Kedia, MD
The Methodist Hospital Research Institute
Central Study Contacts
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
January 1, 2025
Study Completion
January 1, 2025
Last Updated
March 29, 2024
Record last verified: 2024-03