Trial Outcomes & Findings for Beyond Confounders: Addressing Source of Measurement Variability and Error in Shear Wave Elastography (NCT NCT03342560)
NCT ID: NCT03342560
Last Updated: 2019-10-28
Results Overview
We collected guideline suggested shear wave elastography measurements from 20 patients. Guidelines suggest collecting 1) 10 measurements, 2) Asking patient to hold breath during the measurements. As a deviation from guideline suggestions, we collected measurements during free breath movements without asking patient to hold breath. As a deviation from the guideline suggestions, fewer number of measurements (3 measurements) were collected with asking the patient to hold breath during the measurements. All measurements were collected using one type of ultrasound system. All measurements were collected by 2 operators in 2 visits.
COMPLETED
NA
30 participants
Visit 1 and Visit 2, an average of 2.5 hours for each visit
2019-10-28
Participant Flow
All 30 patients were scanned in clinic ultrasound setting. 2 visits were scheduled for each patient. Mean difference between visits was 11 days. Mean difference between liver biopsy date and first visit date was 89 days. 2 patients were lost to followup for 2nd visit.
Participant milestones
| Measure |
Chronic Liver Disease Patients With Known Liver Biopsy Results
Patients with chronic liver disease with known biopsy results
Sonographic SWE measurements with Toshiba/Canon APLIO500: Sonographic Shear wave elastography will be performed to quantify liver fibrosis
Sonographic SWE measurements with Siemens ACUSON S3000: Sonographic Shear wave elastography will be performed to quantify liver fibrosis
Sonographic SWE measurements with GE LOGIQ E9: Sonographic Shear wave elastography will be performed to quantify liver fibrosis
SWE measurements with FibroScan: Transient elastography will be performed to quantify liver fibrosis
|
|---|---|
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Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Chronic Liver Disease Patients With Known Liver Biopsy Results
Patients with chronic liver disease with known biopsy results
Sonographic SWE measurements with Toshiba/Canon APLIO500: Sonographic Shear wave elastography will be performed to quantify liver fibrosis
Sonographic SWE measurements with Siemens ACUSON S3000: Sonographic Shear wave elastography will be performed to quantify liver fibrosis
Sonographic SWE measurements with GE LOGIQ E9: Sonographic Shear wave elastography will be performed to quantify liver fibrosis
SWE measurements with FibroScan: Transient elastography will be performed to quantify liver fibrosis
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Beyond Confounders: Addressing Source of Measurement Variability and Error in Shear Wave Elastography
Baseline characteristics by cohort
| Measure |
30 Patients With Known Liver Biopsy Results
n=30 Participants
Patients with chronic liver disease with known biopsy results
Sonographic SWE measurements with Toshiba APLIO500: Sonographic Shear wave elastography will be performed to quantify liver fibrosis
Sonographic SWE measurements with Siemens ACUSON S3000: Sonographic Shear wave elastography will be performed to quantify liver fibrosis
Sonographic SWE measurements with GE LOGIQ E9: Sonographic Shear wave elastography will be performed to quantify liver fibrosis
SWE measurements with FibroScan: Transient elastography will be performed to quantify liver fibrosis
Sonographic speed of sound measurements with GE LOGIQ E9: Sonographic speed of sound function of the machine will be used to quantify liver steatosis
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|---|---|
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Age, Continuous
|
49 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Fibrosis stage
Fibrosis 0
|
10 participants
n=5 Participants
|
|
Fibrosis stage
Fibrosis 1
|
7 participants
n=5 Participants
|
|
Fibrosis stage
Fibrosis 2
|
3 participants
n=5 Participants
|
|
Fibrosis stage
Fibrosis 3
|
5 participants
n=5 Participants
|
|
Fibrosis stage
Fibrosis 4
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 1 and Visit 2, an average of 2.5 hours for each visitWe collected guideline suggested shear wave elastography measurements from 20 patients. Guidelines suggest collecting 1) 10 measurements, 2) Asking patient to hold breath during the measurements. As a deviation from guideline suggestions, we collected measurements during free breath movements without asking patient to hold breath. As a deviation from the guideline suggestions, fewer number of measurements (3 measurements) were collected with asking the patient to hold breath during the measurements. All measurements were collected using one type of ultrasound system. All measurements were collected by 2 operators in 2 visits.
Outcome measures
| Measure |
Guideline Suggested Measurements
n=20 Participants
10 measurements in an area between 2cm from liver capsule and 6.5cm from skin
|
Fewer Number of Measurements
n=20 Participants
3 SWE measurements were collected.
|
Free Breath Measurements
n=20 Participants
10 SWE measurements were collected during free breath
|
|---|---|---|---|
|
Deviations From Suggested Guidelines- Any Effect on Agreement
ICC for inter-operator agreement in visit1
|
0.77 correlation coefficient
Interval 0.45 to 0.9
|
0.75 correlation coefficient
Interval 0.4 to 0.9
|
0.69 correlation coefficient
Interval 0.26 to 0.87
|
|
Deviations From Suggested Guidelines- Any Effect on Agreement
ICC for inter-operator agreement in visit2
|
0.86 correlation coefficient
Interval 0.64 to 0.94
|
0.80 correlation coefficient
Interval 0.48 to 0.92
|
0.68 correlation coefficient
Interval 0.2 to 0.87
|
|
Deviations From Suggested Guidelines- Any Effect on Agreement
ICCfor intra-op agreement between 2 visits for op1
|
0.94 correlation coefficient
Interval 0.84 to 0.97
|
0.90 correlation coefficient
Interval 0.75 to 0.96
|
0.93 correlation coefficient
Interval 0.61 to 0.98
|
|
Deviations From Suggested Guidelines- Any Effect on Agreement
ICCfor intra-op agreement between 2 visits for op2
|
0.89 correlation coefficient
Interval 0.74 to 0.96
|
0.89 correlation coefficient
Interval 0.73 to 0.96
|
0.95 correlation coefficient
Interval 0.87 to 0.98
|
PRIMARY outcome
Timeframe: Visit 1 and Visit 2, an average of 2.5 hours for each visitIn 20 patients we collected 10 shear wave elastography measurements in m/s and kPA units. Using one of the available ultrasound systems, 2 operators collected these measurements in 2 visits. Theoretically, m/s to kPA conversion can be made using an equation. However, some systems provide opportunity to get data in both units. Although algebraically m/s and kPA can be converted to each other, we found some minor differences in terms of inter-operator and intra-operator agreement.
Outcome measures
| Measure |
Guideline Suggested Measurements
n=20 Participants
10 measurements in an area between 2cm from liver capsule and 6.5cm from skin
|
Fewer Number of Measurements
n=20 Participants
3 SWE measurements were collected.
|
Free Breath Measurements
10 SWE measurements were collected during free breath
|
|---|---|---|---|
|
Interoperator and Intraoperator Agreement in m/s and kPA Units
ICC for inter-operator agreement in visit1
|
0.87 Intraclass correlation coefficient value
Interval 0.47 to 0.96
|
0.84 Intraclass correlation coefficient value
Interval 0.36 to 0.95
|
—
|
|
Interoperator and Intraoperator Agreement in m/s and kPA Units
ICC for inter-operator agreement in visit2
|
0.80 Intraclass correlation coefficient value
Interval 0.26 to 0.94
|
0.77 Intraclass correlation coefficient value
Interval 0.13 to 0.94
|
—
|
|
Interoperator and Intraoperator Agreement in m/s and kPA Units
ICC for intra-operator agreement for opt1
|
0.92 Intraclass correlation coefficient value
Interval 0.71 to 0.97
|
0.88 Intraclass correlation coefficient value
Interval 0.57 to 0.96
|
—
|
|
Interoperator and Intraoperator Agreement in m/s and kPA Units
ICC for intra-operator agreement for opt2
|
0.81 Intraclass correlation coefficient value
Interval 0.35 to 0.94
|
0.78 Intraclass correlation coefficient value
Interval 0.27 to 0.94
|
—
|
Adverse Events
30 Patients With Known Liver Biopsy Results
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place