Upper Gastrointestinal Endoscopy Reporting System in Improving Report Quality

Recruiting

• Conditions: Endoscopy, Gastrointestinal; Artificial Intelligence

• Registration Number: NCT05851716
• Lead Sponsor: Renmin Hospital of Wuhan University

Brief Summary

The goal of this observational study is to evaluate the effectiveness of an AI-based reporting system for upper gastrointestinal endoscopy. The main question it aims to answer is: Whether the AI-based reporting system can improve the completeness of the reports, which are drafted by endoscopists with the AI assistance. Participants will undergo upper gastrointestinal endoscopy examination as routine. The junior endoscopists will draft the report with the assiatance of the AI system. And the senior and expert endoscopists will draft the report using the traditional reporting system without AI assistance.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-30
• Study First Submitted QC: 2023-04-30
• Study First Posted: 2023-05-10
• Status Verified: 2023-08
• Study Start: 2023-08-21
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-05
• Primary Completion: 2024-04-20
• Study Completion: 2024-05-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Aged 18 years
2. Aim to undergo screening, surveillance, and diagnosis
3. Undergo sedated EGD
4. Able to read, understand, and sign informed consent

Exclusion Criteria

1. EGD contraindications
2. Not suitable for sedated endoscopy after anaesthesia evaluation
3. Biopsy contraindications
4. Active upper gastrointestinal bleeding or emergency oesophagogastroduodenoscopy (EGD)
5. Pregnancy
6. Upper gastrointestinal surgery or residual stomach
7. Not suitable for recruitment after investigator evaluation because of other high-risk conditions

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Completeness of reporting lesions	one month	Calculation method = number of report lesions / total number of lesions x 100%

Secondary Outcome Measures

Name	Time	Method
Reporting time	one month	The time that endoscopists draft reports
Completeness of report drafting on lesion features	one month	Calculation method = number of drafted features of lesions / total number of features required to be drafted x 100%
Accuracy of report drafting on lesion features	one month	Calculation method = number of accurately drafted features of lesions / total number of drafted features x 100%
Completeness of reporting lesions of AI system	one month	Calculation method = number of report lesions / total number of lesions x 100%
Accuracy of report drafting on lesion features of AI system	one month	Calculation method = number of accurately drafted features of lesions / total number of drafted features x 100%

Trial Locations

Locations (1)

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China