An interventional study of Information of Appendix (IA) model in Acute Appendicitis, sponsored by Hallym University Medical Center. Recruiting at 1 site in Korea, Republic of. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2023-12-18.
Sponsored by Hallym University Medical Center · Not applicable, Interventional, and Diagnostic
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.
Development of information of appendix model
The pipeline of IA model embedding parameters learned from the 3D CT image of 7,147 patients consisted of a two-stage binary algorithm connected to transfer learning with three 3D CNN models: DenseNet, EfficientNet, and ResNet.
Currently, the final IA model has been externally validated using a never-before-seen dataset from an outside institution with broad eligibility criteria for patients who visited the emergency room with abdominal pain and underwent abdominopelvic CT due to clinical suspicion of acute appendicitis.
Intervention This is a comparative study between human and IA models for the negative appendectomy rate (NAR) in non-, simple, and complicated appendicitis of a prospective randomized dataset, which was collected from CT scans of patients who visited the emergency room with acute abdominal pain. The participants in the control arm were ten non-radiologists.
The IA model is not allowed to impede the preoperative decision process of clinicians in ongoing clinical practice regarding the legal and ethical aspects of interrogating the diagnostic frameworks of the IA model on the mathematical reasoning for an outcome in terms of protecting human subjects.
Considering the minimal risk to human subjects and the ethical and legal aspects of artificial intelligence, the study design strictly allocates CT images to non-radiologists and IA models after completion of treatment for appendicitis with or without pathologic confirmation.
Data allocation and performance evaluation
The primary and secondary outcomes were assessed using the results of the four questions for the participants and the diagnostic performance of the IA model in the same dataset.
Ethical statement According to the "Guide to Utilizing Healthcare Data" and "Guide to Handling Pseudonym Information" of the Personal Information Protection Commission of the Ministry of Health and Welfare, data exfiltration with security assurance of the data archive was conducted with the approval of the Data Review Board at participating institutions. The central institutional review board (IRB) and IRBs of all participating institutions approved this study.
Sample size and statistical methods The investigators's prior study, which completed external validation of the IA model through data exfiltration of external institutions, showed an NAR of 12.4% in the external dataset. The standard reference value for non-radiologists for NAR has been reported as 10.5% ± 5%. Therefore, the acceptable difference in NAR between the IA model and non-radiologists for clinical application should be less than 10.0% of the non-inferiority margin.
The sample size for the randomized controlled dataset for a single institution was 263 assuming a 95% confidence interval, statistical power of 90%, two-tails sided α = 0.05, significance level = 0.05, and effect size = 0.2 at the Z-test. Two external institutions participated in this study. Due to data heterogeneity, normalization, and prevalence differences across regions between the two external institutions, the sample size was calculated for each institution. Therefore, assuming 263 patients per institution with a follow-up loss of 10%, the total sample size was 568.
419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.
This study's planned enrollment of 568 is above the median of 111 across 252 interventional studies indexed under Appendicitis.
Browse Appendicitis studies →Hallym University Medical Center is the lead sponsor of 53 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Inclusion criteria for broad eligibility were applied to reflect that the CT utilization rate in the emergency room has rapidly expanded, presumably in many other institutions where physicians maintain a reasonably sensitive standpoint in raising a clinical suspicion of appendicitis as a cause of abdominal pain and then use CT as an imaging test to confirm or rule out appendicitis.
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.
Exclusion Criteria:
Patients who did not fulfill the CT imaging protocol were excluded in detail as follows:
i) Failure to meet the CT protocol criteria of this study: liver CT, biliary CT, etc. (if contrast phase was different); ureter CT, etc. (if contrast media was not used and the reconstruction method was different); non-enhanced CT (when contrast media was not used); and appendix CT or low-dose CT (when radiation dose was low).
ii) When the quality of the CT image is significantly reduced, as follows: when blurring occurs (motion artifact) or metal artifact (when internal fixation is performed due to spinal surgery).
iii) when it was evident from the medical record review that clinical information suggested that APCT was performed due to the suspicion of a condition other than appendicitis, as follows: suspected acute cholecystitis due to RUQ tenderness and Murphy's sign; suspected urolithiasis due to flank pain and gross hematuria; suspected pancreatitis due to a history of pancreatitis; alcohol abuse; and suspected gynecological diseases due to vaginal discharge. Suspected panperitonitis due to whole abdominal tenderness, rebound tenderness, and unstable vital signs. Patients with acute cholecystitis, ureteral stones, pancreatitis, or acute peritonitis due to small bowel or colon perforation were also excluded.
iv) Patients younger than 10 years were excluded. Adolescent patients from 11 to 18 years old were included in the study if the exclusion criteria were not applicable.
v) diagnosed by ultrasound sonography vi) Patients who were transferred to the emergency department after a diagnosis of appendicitis at an outside hospital or ambulatory care were excluded.
vii) Patients with appendicitis who did not undergo surgical treatment because of the enrollment protocol of other ongoing studies.
viii) patients who had undergone an appendectomy
A fully automated diagnostic framework based on 3D-CNN model to predict non-appendicitis, simple and complicated appendicitis
Device: Information of Appendix (IA) model
Ten non-radiologists participated in this study. CT image same to IA model was allocated to radiologist randomly.
Deep learning model
Negative appendectomy rate
Description: False positive rate = FP /FP +TN FP: false positive, TN true negative Assessment of outcomes: To evaluate diagnostic performance in humans, four test items for non-radiologists were set up as follows: (1) Appendix visualization: Can you find the location of the appendix? ① Yes ② No (2) Exclusion of appendicitis: Can appendicitis be excluded from the CT images? ① Yes (non-appendicitis) ② No (simple or complicated appendicitis) (3) If your choice is "no (simple or complicated appendicitis)," is appendicitis accompanied by complication? ① Yes (complicated appendicitis) ② No (simple appendicitis) (4) Finally, what is the radiologic diagnosis based on CT images in patients presenting with acute right or lower abdominal pain in the ER? ① Non-appendicitis ② simple appendicitis ③ complicated appendicitis The NAR was calculated as the primary endpoint using the outcomes of (2) the answer sheet of the non-radiologist and the Stage 1 IA model-yielding class.
Time frame: Outcome measurement for four test items of non-radiologists will be assessed for an average of one year through study completion.
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hallym University Medical Center