Prospective Randomized Control Study for Exclusion of Negative Appendicitis; Deep Learning Model, Information of Appendix (IA) Versus Non-radiologists

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

the investigators's study group has developed a fully automated 3D convolutional neural network (CNN)-based diagnostic framework using information of appendix (IA) model to identify non-appendicitis and simple and complicated appendicitis on CT scan images based on the two-stage binary classification algorithm, as a clinician does for deciding treatment. The dataset was built from a large population of patients visiting emergency departments who underwent intravenous contrast-enhanced abdominopelvic CT examinations to evaluate abdominal pain in the right or lower quadrant area as the chief complaint. Recently, the IA model was externally validated using a dataset of multicenter institutions through data exfiltration. In this study, the investigators hypothesized that the IA model would show a comparable negative appendicitis rate of \<10% non-inferior margins compared to non-radiologists with a shorter interpretation time in a prospectively randomized dataset.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• When the imaging protocol parameters were as follows: abdomen or pelvis (intravenous contrast, 2 mg/kg, maximum 160 mL), scan timing (portal venous phase), range (from 4 cm above the liver dome to 1 cm below the ischial tuberosity), radiation dose (tube potential, KVP from 100 to 120), pitch 1.75:1, and reconstruction (5 mm, cut slice for adults; 3 mm, cut slice for children under 12 years old), anonymized CT images of patients were referred to a randomized dataset.

Locations
Other Locations
Republic of Korea
Hallym University Medical Center
RECRUITING
Anyang
Contact Information
Primary
Iltae Son
1tae99@hanmail.net
+82-10-2373-4783
Backup
Minsung Kim
bongkay4@gmail.com
+82-10-2087-9792
Time Frame
Start Date: 2023-07-04
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 568
Treatments
Active_comparator: IA model
A fully automated diagnostic framework based on 3D-CNN model to predict non-appendicitis, simple and complicated appendicitis
No_intervention: Non-radiologist
Ten non-radiologists participated in this study. CT image same to IA model was allocated to radiologist randomly.
Related Therapeutic Areas
Sponsors
Collaborators: Doheon Institute for Digital Innovation In Medicine, Medical A.I. Center of Hallym University
Leads: Hallym University Medical Center

This content was sourced from clinicaltrials.gov