Phase 2
Completed N=37
The Role of Contrast Enhanced Ultrasound in Appendicitis
Source: ClinicalTrials.gov NCT03687502 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcomePrimary: Number of Children With an Accurate Diagnosis of Appendicitis. — 6; 15; 1; 13 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Children With an Accurate Diagnosis of Appendicitis. |
6; 15; 1; 13 | — |
| SECONDARY Definitive Diagnosis |
13 | — |
| SECONDARY Number of Participants Who Required Additional CT Scan |
— | — |
| SECONDARY Percentage of Negative Appendectomies |
1 | — |
| SECONDARY Total Cost Difference Compared to Traditional Ultrasound |
16 | — |
| SECONDARY Total Cost Difference Between Traditional Ultrasound in Comparison to Costs in CT Scan. |
6198 | — |
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
- Pregnant
- Lactating
- Received an ultrasound image from a referring facility
Data sourced from ClinicalTrials.gov (NCT03687502). 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. Informational only — not medical advice.