Portal Hypertension Using Magnetic Resonance Elastography

February 28, 2023 updated by: Moon Young Kim, Yonsei University

Non-invasive Assessment of Portal Hypertension Using Quantitative Magnetic Resonance Imaging

This prospective study was conducted in a tertiary university hospital. The investigators researched the correlation between MRE-assessed stiffness of the liver and spleen and the Hepatic venous pressure gradient (HVPG) values. Furthermore, the investigator evaluated whether MRE-assessed stiffness reflected changes in portal hypertension (PH) after administering non-selective beta-blockers (NSBBs).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

47

Contacts and Locations

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

Study Locations

  • Korea, Republic of
    • Gangwon
      • Wŏnju, Gangwon, Korea, Republic of, 22070
        • WonJu Severance Christian Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients requiring prophylactic treatment of esophageal varices

Description

Inclusion Criteria:

  • diagnosed liver cirrhosis
  • requiring prophylactic treatment of esophageal varices

Exclusion Criteria:

  • the coexistence of hepatocellular carcinoma
  • refractory ascites who regularly underwent large-volume paracentesis
  • the use of selective beta-blocker or carvedilol therapy for at least 4 weeks
  • undergoing liver transplantation
  • contraindication with magnetic resonance imaging

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of liver stiffness and spleen stiffness by MRE
Time Frame: Change from baseline stiffness of MRE at 6 months
Change from baseline stiffness of MRE at 6 months
The change of portal pressure (HVPG) prior to and after treatment with NSBB
Time Frame: Change from baseline and at 6 months
Change from baseline and at 6 months

Collaborators and Investigators

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

Sponsor

Yonsei University

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)

January 2, 2018

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

January 28, 2023

Study Registration Dates

First Submitted

February 14, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Actual)

March 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR317132

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Magnetic Resonance Imaging

Clinical Trials on MRE

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe