Evaluation of the Clinical Effectiveness of Upper Gastrointestinal Endoscopy Reporting System

NCT05851885 | Unknown

• 1 other identifier: EA-23-007
• Study Type: interventional
• Target: 125
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to assess the effectiveness of an AI-based reporting system for upper gastrointestinal endoscopy. The primary question that this study aims to address is whether the reporting system can enhance the completeness and accuracy of endoscopic reports when assisted by AI, as drafted by endoscopists. Patients will be randomly assigned to either the experimental group or the control group. In the experimental group, physicians will draft EGD reports with the assistance of the AI-based reporting system, while in the control group, physicians will use the conventional reporting system to draft EGD reports. At the same time, the AI-based reporting system will automatically generate a report of the EGD examination.

Conditions

Endoscopy, Gastrointestinal; Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

• Completeness of reporting lesions

  Calculation method = number of report lesions / total number of lesions x 100%

  one month

Secondary Outcomes (6)

• Completeness of report drafting on lesion features

  one month

• Accuracy of report drafting on lesion features

  one month

• Reporting time

  one month

• Completeness of reporting lesions of AI system

  one month

• Accuracy of report drafting on lesion features of AI system

  one month

Study Arms (2)

Experimental group

EXPERIMENTAL

Physicians draft EGD reports with the assistance of the AI-based reporting system.

Diagnostic Test: AI-based reporting system

Control group

NO INTERVENTION

Physicians use the conventional reporting system to draft EGD reports. At the same time, the AI-based reporting system will automatically generate a report of the EGD examination.

Interventions

AI-based reporting system DIAGNOSTIC_TEST

AI-based reporting system is a software platform for real-time analysis and records of abnormalities and landmarks during endoscopy.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years
• Aim to undergo screening, surveillance, and diagnosis
• Undergo sedated EGD
• Able to read, understand, and sign informed consent

You may not qualify if:

• EGD contraindications
• Not suitable for sedated endoscopy after anaesthesia evaluation
• Biopsy contraindications
• Active upper gastrointestinal bleeding or emergency oesophagogastroduodenoscopy (EGD)
• Pregnancy
• Upper gastrointestinal surgery or residual stomach
• Not suitable for recruitment after investigator evaluation because of other high-risk conditions

Sponsors & Collaborators

• Renmin Hospital of Wuhan University: lead

Study Officials

• Honggang Yu, MD

  Wuhan University Renmin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Honggang Yu, MD

CONTACT

+8613871281899; yuhonggang1968@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2023
• First Posted: May 10, 2023
• Study Start: May 20, 2023
• Primary Completion: April 20, 2024
• Study Completion: May 20, 2024
• Last Updated: May 10, 2023

Record last verified: 2023-04