NCT02673411

Brief Summary

The purpose of this study is to measure diagnostic performance of ultrasound shear wave elastography to detect advanced hepatic fibrosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
29 days until next milestone

Study Start

First participant enrolled

March 3, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2017

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

7 months

First QC Date

February 1, 2016

Last Update Submit

March 16, 2021

Conditions

Cirrhosis

Keywords

elastographyultrasonography

Outcome Measures

Primary Outcomes (1)

  • diagnostic performance to detect advanced hepatic fibrosis

    from ultrasound SWE to perform hepatic resection or percutaneous liver biopsy in patients (with histologic diagnosis)

    1 month

Secondary Outcomes (4)

  • interobserver agreement of ultrasound SWE

    1 day

  • agreement with MR elastography

    1 month

  • Technical success rate

    6 months

  • Reliable measurement rate

    6 months

Interventions

ultrasound shear wave elastographyDEVICE

ultrasound shear wave elastography is performed in GE ultrasound scanner according to guidelines of ultrasound elastography.

Also known as: GE LOGIQ E9

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jeong Min Lee, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 3, 2016

Study Start

March 3, 2016

Primary Completion

September 27, 2016

Study Completion

January 16, 2017

Last Updated

March 17, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)