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Completed

NCT Number: NCT03687502

The Role of Contrast Enhanced Ultrasound in 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.

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Key information

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sulfur hexafluoride lipid-type A microspheres

Drug

Contrast Enhanced Ultrasound of the appendix

Other names: Lumason

Primary outcomes

  1. Number of Children With an Accurate Diagnosis of Appendicitis.

    Time frame: 1 week

    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

Secondary outcomes

  1. Definitive Diagnosis

    Time frame: 1 week

    Proportion of children with definitive diagnosis of appendicitis with use of CEUS.

  2. Number of Participants Who Required Additional CT Scan

    Time frame: 30 days

    "Number of Participants who Required Additional CT Scan"

  3. Percentage of Negative Appendectomies

    Time frame: 1 week

    Percentage of negative appendectomies

  4. Total Cost Difference Compared to Traditional Ultrasound

    Time frame: 60 days

    Costs in comparison to traditional ultrasound

  5. Total Cost Difference Between Traditional Ultrasound in Comparison to Costs in CT Scan.

    Time frame: 60 days

    Comparing total costs difference between traditional ultrasound in comparison to costs in CT scan.

    Total CT Scan Costs - Total Ultrasound Costs = Cost Difference.

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Sep 27, 2018
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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