Back to resultsPreoperative Portal and Splanchnic Flow Measurement Using MRI
Primary Purpose
Liver Cirrhoses
Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Liver MRI
Sponsored by
About this trial
This is an interventional basic science trial for Liver Cirrhoses focused on measuring MRI, cirrhosis
Eligibility Criteria
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Liver MRI
Arm Description
In this study, MRI refers to phase-contrast 4D flow sequence.
Outcomes
Primary Outcome Measures
Portal flow
portal flow measured with MRI (4D flow sequence)
Secondary Outcome Measures
SMV flow
superior mesenteric vein (SMV) flow measured with MRI (4D flow sequence)
Splenic vein flow
splenic vein flow measured with MRI (4D flow sequence)
splenic varix flow
splenic varix flow measured with MRI (4D flow sequence) only in liver recipients
Full Information
NCT ID
NCT03868397
First Posted
March 7, 2019
Last Updated
April 11, 2023
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03868397
Brief Title
Preoperative Portal and Splanchnic Flow Measurement Using MRI
Official Title
Preoperative Portal and Splanchnic Flow Measurement in Living Donor Liver Transplantation Recipient With Spontaneous Portosystemic Shunt at MRI: Preliminary Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 7, 2019 (Actual)
Primary Completion Date
July 12, 2019 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhoses
Keywords
MRI, cirrhosis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liver MRI
Arm Type
Experimental
Arm Description
In this study, MRI refers to phase-contrast 4D flow sequence.
Intervention Type
Diagnostic Test
Intervention Name(s)
Liver MRI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Portal flow
Description
portal flow measured with MRI (4D flow sequence)
Time Frame
in a month after 2nd MRI
Secondary Outcome Measure Information:
Title
SMV flow
Description
superior mesenteric vein (SMV) flow measured with MRI (4D flow sequence)
Time Frame
in a month after 2nd MRI
Title
Splenic vein flow
Description
splenic vein flow measured with MRI (4D flow sequence)
Time Frame
in a month after 2nd MRI
Title
splenic varix flow
Description
splenic varix flow measured with MRI (4D flow sequence) only in liver recipients
Time Frame
in a month after 2nd MRI
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Hee Yoon, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Preoperative Portal and Splanchnic Flow Measurement Using MRI
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