Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements

PORTAL: Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements

The objective of the study is to collect and report technical success of direct endoscopic ultrasound guided hepatic and portal vein pressure measurement obtained with EchoTip® Insight™ in patients with cirrhosis who are referred for an EGD and/or EUS.

Study Overview

• Status: Completed
• Conditions: Liver Diseases; Liver Cirrhosis; Hypertension, Portal
• Intervention / Treatment: Device: EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System (EchoTip® Insight™)

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Australia
  • Herston, Australia, 4029
    • Royal Brisbane Women's Hospital
• Hong Kong
  • Sha Tin, Hong Kong, 999077
    • Prince of Wales Hospital/Chinese University of Hong Kong
• United States
  • California
    • Orange, California, United States, 92868
      • University of California, Irvine
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • The University of Kansas Health System
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's Hospital
  • New York
    • New York, New York, United States, 10021
      • New York-Presbyterian Hospital/Weill Cornell University Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with cirrhosis referred for an EGD/ EUS

Description

Inclusion Criteria:

Patient who has been referred for an EGD and/or EUS procedure and direct pressure measurement.

General Exclusion Criteria:

• 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 is unwilling or unable to comply with the follow-up study schedule.
• Patient for whom endoscopic procedures are contraindicated

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Portal Pressure Gradient Measurement	Number of participants that the Portal Pressure Gradient measurement was obtainable.	once the measurement is calculated (approximately 1 hour)

Collaborators and Investigators

• Sponsor: Cook Research Incorporated
• Investigators: Principal Investigator: Kenneth Chang, MD, FACG, FASGE, University of California, Irvine

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2021
• Primary Completion (Actual): June 13, 2022
• Study Completion (Actual): June 13, 2022

Study Registration Dates

• First Submitted: December 9, 2020
• First Submitted That Met QC Criteria: December 9, 2020
• First Posted (Actual): December 16, 2020

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 17, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Fatty Liver; portal pressure gradient; portal pressure measurement
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Fibrosis; Liver Diseases; Liver Cirrhosis; Hypertension, Portal
• Other Study ID Numbers: 16-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after final report has been distributed and ending 5 years after final report has been distributed. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No