Children's Mercy Kansas City
Kansas City, Missouri, 64108, United States
NCT Number: NCT03687502
This study seeks to determine the efficacy of Contrast Enhanced Ultrasound (CEUS) in improving the diagnosis of acute appendicitis in children, when compared to the standard grey-scale ultrasound.
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Notify Me8 year–17 year
All sexes
Interventional
Phase 2
Kansas City, Missouri, 64108, United States
This will be a single-center, non-randomized trial that will add to our institution's current diagnostic algorithm using Contrast Enhanced Ultra Sound (CEUS) in subjects who are clinically suspicious for acute appendicitis.
For those who consent to study participation, we propose obtaining a CEUS after the initial gray-scale ultrasound. Once the initial ultrasound is complete, the contrast Lumason® (sulfur hexafluoride lipid type-A microspheres) will be administered through an already existing IV catheter and an abdominal scan will be completed. The patient will then continue with standard of care treatment per his treating physician. The CEUS image will be read at a future time by a Children's Mercy Hospital radiologist blinded to the results of the gray scale ultrasound and computed tomography (CT) scan if one was obtained; these will be used for comparison.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Contrast Enhanced Ultrasound of the appendix
Other names: Lumason
Time frame: 1 week
Number of children with an accurate diagnosis of appendicitis when compared to the standard grey scale ultrasound and/ or CT scan based on the following categories:
Category 1: Normal appendix Category 2: Appendix not fully visualized without secondary signs Category 3: Appendix not fully visualized with secondary signs Category 4: Appendicitis
Time frame: 1 week
Proportion of children with definitive diagnosis of appendicitis with use of CEUS.
Time frame: 30 days
"Number of Participants who Required Additional CT Scan"
Time frame: 1 week
Percentage of negative appendectomies
Time frame: 60 days
Costs in comparison to traditional ultrasound
Time frame: 60 days
Comparing total costs difference between traditional ultrasound in comparison to costs in CT scan.
Total CT Scan Costs - Total Ultrasound Costs = Cost Difference.
Children's Mercy Hospital Kansas City
Other
The Role of Contrast Enhanced Ultrasound in The Diagnosis of Children With Appendicitis
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