The Role of Contrast Enhanced Ultrasound in Appendicitis

Acute Appendicitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03687502
• Other study ID #: Study00000329
• Status: Completed
• Phase: Phase 2
• Start date: January 4, 2019
• Est. completion date: July 5, 2022

Study information

• Verified date: September 2023
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: July 5, 2022
• Est. primary completion date: March 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Appendicitis
• Appendicitis

Intervention

Drug:
• Sulfur hexafluoride lipid-type A microspheres
Contrast Enhanced Ultrasound of the appendix

Locations

Country	Name	City	State
United States	Children's Mercy Kansas City	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Definitive Diagnosis	Proportion of children with definitive diagnosis of appendicitis with use of CEUS.	1 week
Secondary	Number of Participants Who Required Additional CT Scan	"Number of Participants who Required Additional CT Scan"	30 days
Secondary	Percentage of Negative Appendectomies	Percentage of negative appendectomies	1 week
Secondary	Total Cost Difference Compared to Traditional Ultrasound	Costs in comparison to traditional ultrasound	60 days
Secondary	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