The Role of Contrast Enhanced Ultrasound in Appendicitis



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:8 - 17
Updated:1/13/2019
Start Date:January 4, 2019
End Date:January 1, 2021
Contact:Tolulope Oyetunji, MD
Email:taoyetunji@cmh.edu
Phone:816-234-3575

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The Role of Contrast Enhanced Ultrasound in The Diagnosis of Children With Appendicitis

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.

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.

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
We found this trial at
1
site
2401 Gillham Road
Kansas City, Missouri 64108
Phone: 816-234-3575
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from
Kansas City, MO
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