Clinical trial NCT03687502: The Role of Contrast Enhanced Ultrasound in Appendicitis
Official title: The Role of Contrast Enhanced Ultrasound in The Diagnosis of Children With Appendicitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Appendicitis
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 37
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Number of Children With an Accurate Diagnosis of Appendicitis.
timeFrame: 1 week
Secondary outcomes:
measure: Definitive Diagnosis
timeFrame: 1 week
measure: Number of Participants Who Required Additional CT Scan
timeFrame: 30 days
measure: Percentage of Negative Appendectomies
timeFrame: 1 week
measure: Total Cost Difference Compared to Traditional Ultrasound
timeFrame: 60 days
measure: Total Cost Difference Between Traditional Ultrasound in Comparison to Costs in CT Scan.
timeFrame: 60 days
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Kansas City
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Tolulope Oyetunji, MD
role: PRINCIPAL_INVESTIGATOR
References: