Acute Appendicitis
Conditions
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.
Interventions
Contrast Enhanced Ultrasound of the appendix
Sponsors
Children's Mercy Hospital Kansas City
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
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
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Children With an Accurate Diagnosis of Appendicitis. | 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
| Measure | Time frame | Description |
|---|---|---|
| Definitive Diagnosis | 1 week | Proportion of children with definitive diagnosis of appendicitis with use of CEUS. |
| Number of Participants Who Required Additional CT Scan | 30 days | Number of Participants who Required Additional CT Scan |
| Percentage of Negative Appendectomies | 1 week | Percentage of negative appendectomies |
| Total Cost Difference Compared to Traditional Ultrasound | 60 days | Costs in comparison to traditional ultrasound |
| Total Cost Difference Between Traditional Ultrasound in Comparison to Costs in CT Scan. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Contrast Enhanced Ultrasound Group 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.
Sulfur hexafluoride lipid-type A microspheres: Contrast Enhanced Ultrasound of the appendix | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | IV was removed prior to radiology visit for ultrasound | 1 |
| Overall Study | Lumason not available | 1 |
Baseline characteristics
| Characteristic | Contrast Enhanced Ultrasound Group |
|---|---|
| Age, Categorical <=18 years | 35 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 11.4 years |
| Race/Ethnicity, Customized Black | 2 Participants |
| Race/Ethnicity, Customized Hispanic | 3 Participants |
| Race/Ethnicity, Customized Multiracial | 3 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 26 Participants |
| Region of Enrollment United States | 35 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
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
Time frame: 1 week
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Contrast Enhanced Ultrasound Group | Number of Children With an Accurate Diagnosis of Appendicitis. | Category 1 | 6 Participants |
| Contrast Enhanced Ultrasound Group | Number of Children With an Accurate Diagnosis of Appendicitis. | Category 2 | 15 Participants |
| Contrast Enhanced Ultrasound Group | Number of Children With an Accurate Diagnosis of Appendicitis. | Category 3 | 1 Participants |
| Contrast Enhanced Ultrasound Group | Number of Children With an Accurate Diagnosis of Appendicitis. | Category 4 | 13 Participants |
Secondary
Definitive Diagnosis
Proportion of children with definitive diagnosis of appendicitis with use of CEUS.
Time frame: 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Contrast Enhanced Ultrasound Group | Definitive Diagnosis | 13 Participants |
Secondary
Number of Participants Who Required Additional CT Scan
Number of Participants who Required Additional CT Scan
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Contrast Enhanced Ultrasound Group | Number of Participants Who Required Additional CT Scan | 0 Participants |
Secondary
Percentage of Negative Appendectomies
Percentage of negative appendectomies
Time frame: 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Contrast Enhanced Ultrasound Group | Percentage of Negative Appendectomies | 1 Participants |
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.
Time frame: 60 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contrast Enhanced Ultrasound Group | Total Cost Difference Between Traditional Ultrasound in Comparison to Costs in CT Scan. | 6198 Dollars |
Secondary
Total Cost Difference Compared to Traditional Ultrasound
Costs in comparison to traditional ultrasound
Time frame: 60 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contrast Enhanced Ultrasound Group | Total Cost Difference Compared to Traditional Ultrasound | 16 Dollars |