The Role of Contrast Enhanced Ultrasound in Appendicitis

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.

Study Overview

• Status: Completed
• Conditions: Acute Appendicitis
• Intervention / Treatment: Drug: Sulfur hexafluoride lipid-type A microspheres

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Kansas City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Sulfur hexafluoride lipid-type A microspheres; Contrast Enhanced Ultrasound of the appendix; Other Names: Lumason

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Children With an Accurate Diagnosis of Appendicitis.	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	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Definitive Diagnosis	Proportion of children with definitive diagnosis of appendicitis with use of CEUS.	1 week
Number of Participants Who Required Additional CT Scan	"Number of Participants who Required Additional CT Scan"	30 days
Percentage of Negative Appendectomies	Percentage of negative appendectomies	1 week
Total Cost Difference Compared to Traditional Ultrasound	Costs in comparison to traditional ultrasound	60 days
Total Cost Difference Between Traditional Ultrasound in Comparison to Costs in CT Scan.	Comparing total costs difference between traditional ultrasound in comparison to costs in CT scan. Total CT Scan Costs - Total Ultrasound Costs = Cost Difference.	60 days

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City
• Investigators: Principal Investigator: Tolulope Oyetunji, MD, Children's Mercy Hospital Kansas City

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2019
• Primary Completion (Actual): March 26, 2021
• Study Completion (Actual): July 5, 2022

Study Registration Dates

• First Submitted: September 24, 2018
• First Submitted That Met QC Criteria: September 25, 2018
• First Posted (Actual): September 27, 2018

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Appendicitis
• Other Study ID Numbers: Study00000329

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No