The Use of AI to Improve Quality of OGD

NCT04883567 | Unknown DMC

• 1 other identifier: 2021.061
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dyspepsia; Anemia; Acid Reflux; Dysphagia

Keywords

oesophagogastroduodenoscopy (OGD); artificial intelligence; quality of OGD

Outcome Measures

Primary Outcomes (1)

• The number of sites inspected during OGD

  There is a standardised 28 sites the trainee endoscopist need to inspect

  During the procedure

Secondary Outcomes (3)

• Overall inspection time

  During the procedure

• The individual sites inspection time

  During the procedure

• The number of positive pathologies found on OGD

  during the procedure

Study Arms (2)

AI arm

AI would be used to assist the trainee endoscopist

Diagnostic Test: The use of artificial intelligence system Cerebro

Non-AI arm

Trainee endoscopist would perform OGD as usual.

Interventions

The use of artificial intelligence system Cerebro DIAGNOSTIC_TEST

The artificial intelligence system Cerebro would be used during OGD

AI arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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,
• Patients' condition requiring therapeutic endoscopy,
• Early termination of endoscopy due to patient intolerance, presence of large amount of food residue, presence of mechanical obstruction or for reasons of safety,
• Patients with altered anatomy such as history of esophagectomy, gastrectomy, gastric bypass surgery, or Whipple's operation,
• Patient who are not suitable for EGD examination (such as acute peritonitis with suspected perforated bowel)
• Pregnant females
• Patients who refuse to participate in the study
• Patients who are unfit for consent.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, 0000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Dyspepsia; Anemia; Gastroesophageal Reflux; Deglutition Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases; Esophageal Motility Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Shannon Chan

CONTACT

35052627; shannonchan@surgery.cuhk.edu.hk

Philip Chiu

CONTACT

35052627; philipchiu@surgery.cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 12, 2021
• Study Start: May 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: May 12, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)