Portal Hypertension Using Magnetic Resonance Elastography

Portal Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05749198
• Other study ID #: CR317132
• Status: Completed
• Start date: January 2, 2018
• Est. completion date: January 28, 2023

Study information

• Verified date: February 2023
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: January 28, 2023
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Portal
• Magnetic Resonance Imaging
• Portal Hypertension

Intervention

Diagnostic Test:
• MRE
MRE was performed using a 3T system (Magnetom Skyra; Siemens, Erlangen, Germany) equipped with a combination of a 30-channel body and a 32-channel spine matrix coil.

Locations

Country	Name	City	State
Korea, Republic of	Wonju Severance Christian Hospital	Wonju	Gangwon

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of liver stiffness and spleen stiffness by MRE		Change from baseline stiffness of MRE at 6 months
Primary	The change of portal pressure (HVPG) prior to and after treatment with NSBB		Change from baseline and at 6 months