CirrhosisNCT02673411
Ultrasonography SWE for Hepatic Fibrosis Evaluation
An observational study of Cirrhosis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to measure diagnostic performance of ultrasound shear wave elastography to detect advanced hepatic fibrosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cirrhosis
- What is being tested?
- ultrasound shear wave elastography
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Mar 2016to 16 Jan 2017
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who are scheduled to undergo liver resection or liver biopsy (n=138). Volunteers who agree to undergo US shear wave elastography (n=20) to determine inter-observer agreement.
Who may be able to join
- volunteers who agree to undergo US shear elastography OR
- patients with chronic liver disease who are scheduled to undergo liver resection or liver parenchymal biopsy.
- AND
- = or > 18 years
- sign informed consent
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Performance of Shear Wave Elastography for Fibrosis Evaluation: Preliminary Study
The purpose of this study is to measure diagnostic performance of ultrasound shear wave elastography to detect advanced hepatic fibrosis.
Read the detailed description
Hepatic fibrosis causes liver dysfunction and HCC. Since hepatic fibrosis is reversible dynamic condition, its monitoring is important to predict long term outcome and to determine treatment plan.
The reference of standard to diagnose hepatic fibrosis is biopsy, but recently non-invasive method such as stiffness imaging has been drawing a lot of attention. In this study, ultrasound shear wave elastography will be performed and its diagnostic performance to detect advanced hepatic fibrosis (= > F2) will be measured using histologic grade as a reference.
- Conditions
- Cirrhosis
- Being tested
- ultrasound shear wave elastography
- Keywords
- elastography, ultrasonography
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound shear wave elastographyDevice
Also called GE LOGIQ E9
ultrasound shear wave elastography is performed in GE ultrasound scanner according to guidelines of ultrasound elastography.
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic performance to detect advanced hepatic fibrosis
from ultrasound SWE to perform hepatic resection or percutaneous liver biopsy in patients (with histologic diagnosis)
Measured: 1 month
Secondary outcomes (4)
interobserver agreement of ultrasound SWE
two observers perform ultrasound SWE on the same day in volunteers.
Measured: 1 day
agreement with MR elastography
interval between US and MR elastography in patients with available MR elastography
Measured: 1 month
Technical success rate
technical success or failure of US elastography using GE LOGIQ E9 scanner in ALL study population
Measured: 6 months
Reliable measurement rate
reliable measurement rate (interquartile range of serial measurement/median LS value <30%) in patients with technically successful US elastography
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study start3 Mar 2016
- Primary completion27 Sep 2016
- Study completion16 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Min Lee, Seoul National University Hospital
- Investigators
- Jeong Min Lee, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673411
- Sponsor's protocol ID
- SNUH-2016-0065
- Status last verified
- Mar 2021
- First submitted
- 1 Feb 2016
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of Shear Wave Elastography for Fibrosis Evaluation: Preliminary Study
- ClinicalTrials.gov ID
- NCT02673411
- Acronym / sponsor ID
- SNUH-2016-0065
- Conditions
- Cirrhosis
- Keywords
- elastography, ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 3 Mar 2016 (actual)
- Primary completion
- 27 Sep 2016 (actual)
- Study completion
- 16 Jan 2017 (actual)
- First posted
- 3 Feb 2016 (estimated)
- 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.
The purpose of this study is to measure diagnostic performance of ultrasound shear wave elastography to detect advanced hepatic fibrosis.
Detailed description
Hepatic fibrosis causes liver dysfunction and HCC. Since hepatic fibrosis is reversible dynamic condition, its monitoring is important to predict long term outcome and to determine treatment plan.
The reference of standard to diagnose hepatic fibrosis is biopsy, but recently non-invasive method such as stiffness imaging has been drawing a lot of attention. In this study, ultrasound shear wave elastography will be performed and its diagnostic performance to detect advanced hepatic fibrosis (= > F2) will be measured using histologic grade as a reference.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are scheduled to undergo liver resection or liver biopsy (n=138). Volunteers who agree to undergo US shear wave elastography (n=20) to determine inter-observer agreement.
Key inclusion criteria (5 listed)
- volunteers who agree to undergo US shear elastography OR
- patients with chronic liver disease who are scheduled to undergo liver resection or liver parenchymal biopsy.
- AND
- = or > 18 years
- sign informed consent
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| ultrasound shear wave elastographyAlso: GE LOGIQ E9ultrasound shear wave elastography is performed in GE ultrasound scanner according to guidelines of ultrasound elastography. | Device | – |
Primary outcome
diagnostic performance to detect advanced hepatic fibrosis
Time frame: 1 month
from ultrasound SWE to perform hepatic resection or percutaneous liver biopsy in patients (with histologic diagnosis)
4 secondary outcomes
interobserver agreement of ultrasound SWE
Time frame: 1 day
agreement with MR elastography
Time frame: 1 month
Technical success rate
Time frame: 6 months
Reliable measurement rate
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- 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 Min Lee, 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?
An observational study of Cirrhosis, 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 5 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: finished, as of the sponsor's last update on 17 Mar 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
diagnostic performance to detect advanced hepatic fibrosis (time frame: 1 month). 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 17 Mar 2021.