Liver CirrhosesNCT03868397
Preoperative Portal and Splanchnic Flow Measurement Using MRI
A study testing Liver MRI in people with Liver Cirrhoses, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhoses
- What is being tested?
- Liver MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Mar 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- older than 18 years
- And signed informed consent
- And planned either a) liver transplantation as a recipient; or b) liver transplantation as a donor
Who cannot join
- any absolute/relative contraindication of contrast-enhanced MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Liver Cirrhoses
- Being tested
- Liver MRI
- Keywords
- MRI, cirrhosis
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Liver MRI | Experimental | In this study, MRI refers to phase-contrast 4D flow sequence. Receives: Diagnostic Test: Liver MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Portal flow
portal flow measured with MRI (4D flow sequence)
Measured: in a month after 2nd MRI
Secondary outcomes (3)
SMV flow
superior mesenteric vein (SMV) flow measured with MRI (4D flow sequence)
Measured: in a month after 2nd MRI
Splenic vein flow
splenic vein flow measured with MRI (4D flow sequence)
Measured: in a month after 2nd MRI
splenic varix flow
splenic varix flow measured with MRI (4D flow sequence) only in liver recipients
Measured: in a month after 2nd MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start7 Mar 2019
- Primary completion12 Jul 2019
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosesStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Hee Yoon, Seoul National University Hospital
- Investigators
- Jeong Hee Yoon, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868397
- Sponsor's protocol ID
- SNUH-2017-1262
- Status last verified
- Apr 2023
- First submitted
- 7 Mar 2019
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Portal and Splanchnic Flow Measurement in Living Donor Liver Transplantation Recipient With Spontaneous Portosystemic Shunt at MRI: Preliminary Study
- ClinicalTrials.gov ID
- NCT03868397
- Acronym / sponsor ID
- SNUH-2017-1262
- Conditions
- Liver Cirrhoses
- Keywords
- MRI, cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 12 Jul 2019 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver MRI | Experimental | Diagnostic Test: Liver MRIIn this study, MRI refers to phase-contrast 4D flow sequence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- older than 18 years
- And signed informed consent
- And planned either a) liver transplantation as a recipient; or b) liver transplantation as a donor
Key exclusion criteria (1 listed)
- any absolute/relative contraindication of contrast-enhanced MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver MRILiver 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. | Diagnostic test | Liver MRI |
Primary outcome
Portal flow
Time frame: in a month after 2nd MRI
portal flow measured with MRI (4D flow sequence)
3 secondary outcomes
SMV flow
Time frame: in a month after 2nd MRI
Splenic vein flow
Time frame: in a month after 2nd MRI
splenic varix flow
Time frame: in a month after 2nd MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeong Hee Yoon, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liver MRI in people with Liver Cirrhoses, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Portal flow (time frame: in a month after 2nd MRI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.