Trial Outcomes & Findings for Shear Wave Sonoelastography in Pediatric Liver Fibrosis (NCT NCT02372682)
NCT ID: NCT02372682
Last Updated: 2019-09-12
Results Overview
METAVIR score is a tool used to measure fibrosis as seen on liver biopsy and scored to describe liver disease progress and prognosis.
Recruitment status
COMPLETED
Target enrollment
171 participants
Primary outcome timeframe
2 years
Results posted on
2019-09-12
Participant Flow
Participant milestones
| Measure |
Test
Any pediatric patient (0-18 years of age) with known liver disease in whom a liver biopsy is to be performed as standard of care to assess the degree of fibrosis will also undergo an abdominal ultrasound to evaluate the liver.
Underlying diagnoses include but are not limited to biliary atresia, congenital fibrosis-cholestasis, Alagille syndrome, Caroli's disease, choledochal cyst, alpha-1-antitrypsin deficiency, progressive familial intrahepatic cholestasis (PFIC), viral hepatitis, glycogenosis, fructosemia, Wilson disease, cystic fibrosis, autosomal recessive polycystic kidney disease (ARPCKD), mesenterico-caval shunt, post liver transplant, and nonalcoholic steatohepatitis (NASH).
Shear wave sonoelastography: Sonoelastography is to be performed on the liver.
|
Control
Any pediatric patient (0-18 years of age) undergoing evaluation with an abdominal ultrasound as standard of care for evaluation for a diagnosis other than liver disease and in whom the US shows a normal liver, gallbladder, pancreas, spleen, and biliary tree will then be asked to enroll in the research study by undergoing shear wave elastography.
Shear wave sonoelastography: Sonoelastography is to be performed on the liver.
|
|---|---|---|
|
Overall Study
STARTED
|
78
|
93
|
|
Overall Study
COMPLETED
|
70
|
79
|
|
Overall Study
NOT COMPLETED
|
8
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Test
n=70 Participants
Any pediatric patient (0-18 years of age) with known liver disease in whom a liver biopsy is to be performed as standard of care to assess the degree of fibrosis will also undergo an abdominal ultrasound to evaluate the liver.
Underlying diagnoses include but are not limited to biliary atresia, congenital fibrosis-cholestasis, Alagille syndrome, Caroli's disease, choledochal cyst, alpha-1-antitrypsin deficiency, progressive familial intrahepatic cholestasis (PFIC), viral hepatitis, glycogenosis, fructosemia, Wilson disease, cystic fibrosis, autosomal recessive polycystic kidney disease (ARPCKD), mesenterico-caval shunt, post liver transplant, and nonalcoholic steatohepatitis (NASH).
Shear wave sonoelastography: Sonoelastography is to be performed on the liver.
|
Control
n=79 Participants
Any pediatric patient (0-18 years of age) undergoing evaluation with an abdominal ultrasound as standard of care for evaluation for a diagnosis other than liver disease and in whom the US shows a normal liver, gallbladder, pancreas, spleen, and biliary tree will then be asked to enroll in the research study by undergoing shear wave elastography.
Shear wave sonoelastography: Sonoelastography is to be performed on the liver.
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.9 years
STANDARD_DEVIATION 6.0 • n=70 Participants
|
11.0 years
STANDARD_DEVIATION 4.5 • n=79 Participants
|
10.9 years
STANDARD_DEVIATION 5.2 • n=149 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=70 Participants
|
55 Participants
n=79 Participants
|
89 Participants
n=149 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=70 Participants
|
24 Participants
n=79 Participants
|
60 Participants
n=149 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
BMI
|
25.5 kg/m^2
STANDARD_DEVIATION 8.4 • n=70 Participants
|
19.7 kg/m^2
STANDARD_DEVIATION 4.8 • n=79 Participants
|
23.5 kg/m^2
STANDARD_DEVIATION 13.1 • n=149 Participants
|
PRIMARY outcome
Timeframe: 2 yearsMETAVIR score is a tool used to measure fibrosis as seen on liver biopsy and scored to describe liver disease progress and prognosis.
Outcome measures
| Measure |
Controls+METAVIR 0
n=112 Participants
Controls+METAVIR 0 (no portal fibrosis)
|
METAVIR F1
n=16 Participants
portal fibrosis without septa
|
METAVIR F2
n=11 Participants
portal fibrosis with few septa
|
METAVIR F3
n=10 Participants
septal fibrosis without cirrhosis
|
Ishak 4
Fibrous expansion of portal areas, with marked bridging (portal to portal (P-P) as well as portal to central (P-C)
|
|---|---|---|---|---|---|
|
2D-SWE Measurements' Capability of Predicting Stages of Fibrosis Based on METAVIR Scoring System
Sensitivity
|
NA percentage of exams
For pts without liver disease/fibrosis to be detected, no correlation can be made to determine sensitivity
|
96.9 percentage of exams
|
95.2 percentage of exams
|
1.00 percentage of exams
|
—
|
|
2D-SWE Measurements' Capability of Predicting Stages of Fibrosis Based on METAVIR Scoring System
Specificity
|
NA percentage of exams
For pts without liver disease/fibrosis to be detected, no correlation can be made to determine specificity
|
80.2 percentage of exams
|
70.7 percentage of exams
|
64.1 percentage of exams
|
—
|
|
2D-SWE Measurements' Capability of Predicting Stages of Fibrosis Based on METAVIR Scoring System
PPV
|
NA percentage of exams
For pts without liver disease/fibrosis to be detected, no correlation can be made to determine PPV
|
66.0 percentage of exams
|
42.6 percentage of exams
|
21.3 percentage of exams
|
—
|
|
2D-SWE Measurements' Capability of Predicting Stages of Fibrosis Based on METAVIR Scoring System
NPV
|
NA percentage of exams
For pts without liver disease/fibrosis to be detected, no correlation can be made to determine NPV
|
98.5 percentage of exams
|
98.5 percentage of exams
|
1.00 percentage of exams
|
—
|
PRIMARY outcome
Timeframe: 2 yearsIshak is a tool used to evaluate liver fibrosis via liver biopsy to report severity and prognosis of liver disease, specifically hepatitis.
Outcome measures
| Measure |
Controls+METAVIR 0
n=111 Participants
Controls+METAVIR 0 (no portal fibrosis)
|
METAVIR F1
n=14 Participants
portal fibrosis without septa
|
METAVIR F2
n=3 Participants
portal fibrosis with few septa
|
METAVIR F3
n=14 Participants
septal fibrosis without cirrhosis
|
Ishak 4
n=7 Participants
Fibrous expansion of portal areas, with marked bridging (portal to portal (P-P) as well as portal to central (P-C)
|
|---|---|---|---|---|---|
|
2D-SWE Measurements' Capability of Predicting Stages of Fibrosis Based on Ishak Scoring System
Sensitivity
|
NA percentage of exams
For pts without liver disease/fibrosis to be detected, no correlation can be made to determine sensitivity
|
93.8 percentage of exams
|
95.8 percentage of exams
|
95.2 percentage of exams
|
100.0 percentage of exams
|
|
2D-SWE Measurements' Capability of Predicting Stages of Fibrosis Based on Ishak Scoring System
Specificity
|
NA percentage of exams
For pts without liver disease/fibrosis to be detected, no correlation can be made to determine specificity
|
79.0 percentage of exams
|
73.0 percentage of exams
|
70.7 percentage of exams
|
62.3 percentage of exams
|
|
2D-SWE Measurements' Capability of Predicting Stages of Fibrosis Based on Ishak Scoring System
PPV
|
NA percentage of exams
For pts without liver disease/fibrosis to be detected, no correlation can be made to determine PPV
|
63.8 percentage of exams
|
48.9 percentage of exams
|
42.6 percentage of exams
|
14.9 percentage of exams
|
|
2D-SWE Measurements' Capability of Predicting Stages of Fibrosis Based on Ishak Scoring System
NPV
|
NA percentage of exams
For pts without liver disease/fibrosis to be detected, no correlation can be made to determine NPV
|
96.9 percentage of exams
|
98.5 percentage of exams
|
98.5 percentage of exams
|
100.0 percentage of exams
|
Adverse Events
Test
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Anna Hardy, Research Nurse Coordinator
Saint Louis University
Phone: 314-268-5785
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee GE - Contract states: "The Institution \[SLU/PI\] is free to publish or present the results of the Study. The Institution agrees to provide Company with a copy of the published manuscript. Company's support will be acknowledged in all such publications or presentations." Thrasher - No restrictions on publication Society of Pediatric Radiology - Manuscripts must be first submitted to SPR annual Meeting and/or to Pediatric Radiology journal, to be considered for publication.
- Publication restrictions are in place
Restriction type: OTHER