The Use of AI to Improve Quality of OGD

The Use of Artificial Intelligence Real-time Feedback to Improve Compliance to a Standardised Protocol and Procedural Quality During Oesophagogastroduodenoscopy (OGD)

Early and accurate recognition of gastrointestinal lesions has implications for public health. The quality of oesophagogastroduodenoscopy (OGD) has great impact on the detection of oesophageal and gastric malignancies. An AI system, Cerebro, has been developed as a real-time recognition of a pre-defined 28 locations. This system would alert the endoscopist if the sites were not inspected with adequate time. The aim of the study is to investigate the use of AI in endoscopists-in-training during OGD to provide a real-time feedback for ensuring compliance to a standardized protocol for examination. The hypothesis is that the use of AI system Cerebro will significantly improve the compliance to the protocol and thereby reduce the blind spot rates of OGD, ensure adequate inspection time and ensure adequate photodocumentation.

Study Overview

• Status: Recruiting
• Conditions: Dyspepsia; Anemia; Dysphagia; Acid Reflux
• Intervention / Treatment: Diagnostic test: The use of artificial intelligence system Cerebro

• Study Type: Observational
• Enrollment (Anticipated): 210

Contacts and Locations

• Study Contact: Name: Shannon Chan; Phone Number: 35052627; Email: shannonchan@surgery.cuhk.edu.hk
• Study Contact Backup: Name: Philip Chiu; Phone Number: 35052627; Email: philipchiu@surgery.cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 0000
    • Recruiting
    • The Chinese University of Hong Kong
    • Contact: Shannon Chan; Phone Number: 35052627; Email: shannonchan@surgery.cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study includes all patients who require an OGD in the Prince of Wales Hospital. The inclusion and exclusion criteria were stated in the previous section.

Description

Inclusion Criteria:

1. All patients aged >= 18 years old
2. Undergoing diagnostic OGD for evaluation of their symptoms in the Prince of Wales Hospital will be included in the study.

Exclusion Criteria:

1. Patients in which a full endoscopic examination is not required including patients with a specific diagnostic purpose without the need for a full evaluation, follow-up endoscopy within 8 weeks for a previously diagnosed disease or condition,
2. Patients' condition requiring therapeutic endoscopy,
3. Early termination of endoscopy due to patient intolerance, presence of large amount of food residue, presence of mechanical obstruction or for reasons of safety,
4. Patients with altered anatomy such as history of esophagectomy, gastrectomy, gastric bypass surgery, or Whipple's operation,
5. Patient who are not suitable for EGD examination (such as acute peritonitis with suspected perforated bowel)
6. Pregnant females
7. Patients who refuse to participate in the study
8. Patients who are unfit for consent.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AI arm; AI would be used to assist the trainee endoscopist	Diagnostic test: The use of artificial intelligence system Cerebro; The artificial intelligence system Cerebro would be used during OGD
Non-AI arm; Trainee endoscopist would perform OGD as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of sites inspected during OGD	There is a standardised 28 sites the trainee endoscopist need to inspect	During the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall inspection time	The overall inspection time during the OGD would be recorded in terms of seconds	During the procedure
The individual sites inspection time	The individual inspection time of the 28 sites during OGD would be recorded in terms of seconds	During the procedure
The number of positive pathologies found on OGD	The number of positive pathologies found on OGD would be recorded	during the procedure

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 12, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: artificial intelligence; oesophagogastroduodenoscopy (OGD); quality of OGD
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: 2021.061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No