Preoperative Portal and Splanchnic Flow Measurement Using MRI

April 11, 2023 updated by: Jeong Hee Yoon, Seoul National University Hospital

Preoperative Portal and Splanchnic Flow Measurement in Living Donor Liver Transplantation Recipient With Spontaneous Portosystemic Shunt at MRI: Preliminary Study

This study aims to assess the alteration of portal and splanchnic flow using MRI after liver transplantation in patients with splenomegaly or splenic varix.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

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

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

Description

Inclusion Criteria:

  • older than 18 years
  • And signed informed consent
  • And planned either a) liver transplantation as a recipient; or b) liver transplantation as a donor

Exclusion Criteria:

  • any absolute/relative contraindication of contrast-enhanced MRI

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

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liver MRI
In this study, MRI refers to phase-contrast 4D flow sequence.
Diagnostic test: Liver MRI

Liver MRI including 4D flow sequence is performed twice in liver transplantation recipients, before and 1 month-after transplantation.

In donor candidates, liver MRI including 4D flow sequence is performed twice in 1-3 weeks to assess repeatability of the technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Portal flow
Time Frame: in a month after 2nd MRI
portal flow measured with MRI (4D flow sequence)
in a month after 2nd MRI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SMV flow
Time Frame: in a month after 2nd MRI
superior mesenteric vein (SMV) flow measured with MRI (4D flow sequence)
in a month after 2nd MRI
Splenic vein flow
Time Frame: in a month after 2nd MRI
splenic vein flow measured with MRI (4D flow sequence)
in a month after 2nd MRI
splenic varix flow
Time Frame: in a month after 2nd MRI
splenic varix flow measured with MRI (4D flow sequence) only in liver recipients
in a month after 2nd MRI

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

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)

March 7, 2019

Primary Completion (Actual)

July 12, 2019

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

March 7, 2019

First Submitted That Met QC Criteria

March 7, 2019

First Posted (Actual)

March 11, 2019

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUH-2017-1262

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 Liver Cirrhoses

Clinical Trials on Liver MRI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe