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N/A N=30 Diagnostic

Beyond Confounders: Addressing Source of Measurement Variability and Error in Shear Wave Elastography

Liver Fibrosis · Liver Diseases

Enrolled (actual)
30
Serious AEs
Results posted
Oct 2019
Primary outcome: Primary: Deviations From Suggested Guidelines- Any Effect on Agreement — 0.77; 0.75; 0.69; 0.86 correlation coefficient

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Sonographic SWE measurements with 4 different ultrasound systems (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Massachusetts General Hospital
Primary completion
Aug 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Deviations From Suggested Guidelines- Any Effect on Agreement
0.77; 0.75; 0.69; 0.86; 0.80; 0.68
PRIMARY
Interoperator and Intraoperator Agreement in m/s and kPA Units
0.87; 0.84; 0.80; 0.77; 0.92; 0.88

Summary

Chronic liver disease is a major problem in the general population and there is an unmet need to diagnose(and screen) for liver disease with using noninvasive, cost-effective and sensitive techniques.The investigators hypothesize that variation using ultrasound elastography for the estimation of stage of liver fibrosis and steatosis in patients with diffuse liver disease exists due to different methods of measurements, and/or different systems. The proposed investigation is a cross-sectional study using ultrasound elastography and fat quantification modalities. The investigators are planning to enroll 30 subjects 18 years old and older in whom diffuse liver disease is suspected, and who have undergone non-focal liver biopsy in the past 6 months or are scheduled to undergo biopsy within 3 months of enrollment, as part of their routine clinical care. The investigators will use 4 different ultrasound devices with their shear wave elastography and speed of sound functions. Specific aims; * Compare shear wave elastography(SWE) measurements from different ultrasound systems; using histopathology as reference standards. * Assess intra-operator and inter-operator reliability by measuring variability in elastography values by two operators on a single system. * Determine the effect of deviations from guidelines(less number of measurements and measurements during active breath)

Eligibility Criteria

Inclusion Criteria

  • Adult Patients
  • Men or Woman
  • Suspected diffuse liver disease and have had a liver biopsy within the last 6 months or are scheduled for a liver biopsy in the next 3 months.
  • Consent to participate in the study

Exclusion Criteria

  • Pregnancy
  • Acute illness/ cognitive impairment resulting in inability to cooperate with ultrasound
  • Patients that do not consent to ultrasound examination
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03342560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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