NCT03868397

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

March 7, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2019

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

4 months

First QC Date

March 7, 2019

Last Update Submit

April 11, 2023

Conditions

Liver Cirrhoses

Keywords

MRIcirrhosis

Outcome Measures

Primary Outcomes (1)

  • Portal flow

    portal flow measured with MRI (4D flow sequence)

    in a month after 2nd MRI

Secondary Outcomes (3)

  • SMV flow

    in a month after 2nd MRI

  • Splenic vein flow

    in a month after 2nd MRI

  • splenic varix flow

    in a month after 2nd MRI

Study Arms (1)

Liver MRI

EXPERIMENTAL

In this study, MRI refers to phase-contrast 4D flow sequence.

Diagnostic Test: Liver MRI

Interventions

Liver MRIDIAGNOSTIC_TEST

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.

Liver MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • any absolute/relative contraindication of contrast-enhanced MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jeong Hee Yoon, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 7, 2019

First Posted

March 11, 2019

Study Start

March 7, 2019

Primary Completion

July 12, 2019

Study Completion

December 31, 2023

Last Updated

April 13, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)