Evaluation of the Clinical Effectiveness of Upper Gastrointestinal Endoscopy Reporting System

Wuhan University

Status: Not yet enrolling

Conditions: Endoscopy, Gastrointestinal; Artificial Intelligence

Treatments: Diagnostic Test: AI-based reporting system

Study type: Interventional

Funder types: Other

Identifiers

NCT05851885

EA-23-007

Details and patient eligibility

About

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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

125 participants in 2 patient groups

Experimental group

Experimental group

Description:

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

Treatment:

Diagnostic Test: AI-based reporting system

Control group

No Intervention group

Description:

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.