The Role of Contrast Enhanced Ultrasound in The Diagnosis of Children With Appendicitis
Overview
- Phase
- Phase 2
- Intervention
- Sulfur hexafluoride lipid-type A microspheres
- Conditions
- Acute Appendicitis
- Sponsor
- Children's Mercy Hospital Kansas City
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Number of Children With an Accurate Diagnosis of Appendicitis.
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Tolulope Oyetunji
MD, Director, Health Outcomes Research, Department of Surgery
Children's Mercy Hospital Kansas City
Eligibility Criteria
Inclusion Criteria
- •Present to Children's Mercy Adele Hall campus with a clinical concern for acute appendicitis
- •Age 8 through 17 years
- •seen between Institutional Review Board (IRB) approval date and 12/31/2019
- •Seen Monday- Friday between the hours of 9:00 a.m. and 4:00 pm
- •Has had an IV catheter placed as part of their standard of care
Exclusion Criteria
- •Known cardiac abnormality
- •Pulmonary hypertension
- •Known sensitivity to sulfur hexafluoride, polyethylene glycol 4000, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), or palmitic acid
- •Does not had an IV catheter placed
- •Unable to roll over
- •Unable to assent
- •Lactating
- •Received an ultrasound image from a referring facility
Arms & Interventions
Experimental
IV sulfur hexafluoride lipid-type A microspheres, 0.03 mL/kg, up to 2 doses per examination, total dose not to exceed 4.8 mL. Single examination per patient.
Intervention: Sulfur hexafluoride lipid-type A microspheres
Outcomes
Primary Outcomes
Number of Children With an Accurate Diagnosis of Appendicitis.
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
Secondary Outcomes
- Definitive Diagnosis(1 week)
- Number of Participants Who Required Additional CT Scan(30 days)
- Percentage of Negative Appendectomies(1 week)
- Total Cost Difference Compared to Traditional Ultrasound(60 days)
- Total Cost Difference Between Traditional Ultrasound in Comparison to Costs in CT Scan.(60 days)