The Research of AI Assistant Gastroscope Training

The Research of Artificial Intelligence Assistance System Effectiveness for Novice Endoscopists Gastroscopy Training

In this study, we proposed a prospective study about the effectiveness of artificial intelligence system for gastroscope training in novice endoscopists. The subjects would be divided into two groups. The experimental group would be trained in painless gastroscopy with the assistance of the artificial intelligence assistant system. The artificial intelligence assistant system can prompt abnormal lesions and the parts covered by the examination (the stomach is divided into 26 parts). The control group would receive routine painless gastroscopy training without special prompts. Then we compare the gastroscopy operation score, coverage rate of blind spots in gastroscopy,check the average test score before and after training, training satisfaction, detection rate of lesions and so on between the two group.

Study Overview

• Status: Completed
• Conditions: Training; Artificial Intelligence; Gastroscopy
• Intervention / Treatment: Other: Artificial intelligence assistant system

Detailed Description

In this study, we proposed a prospective study about the effectiveness of artificial intelligence system for gastroscope training in novice endoscopists. The subjects would be divided into two groups. The experimental group would be trained in painless gastroscopy with the assistance of the artificial intelligence assistant system. The artificial intelligence assistant system can prompt abnormal lesions and the parts covered by the examination (the stomach is divided into 26 parts). The control group would receive routine painless gastroscopy training without special prompts. Then we compare the gastroscopy operation score, coverage rate of blind spots in gastroscopy,check the average test score before and after training, training satisfaction, detection rate of lesions and so on between the two group.

• Study Type: Interventional
• Enrollment (Actual): 288
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Wuhan, China, 430060
    • Renmin Hospital of Wuhan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Novice endoscopists：

Inclusion Criteria:

1. Males or females who are over 18 years old;
2. After qualified medical education and obtained the Certificate of Chinese medical practitioner;

Exclusion Criterial:

1. A doctor who has already been trained in gastroenteroscopy;
2. Doctors without qualified medical education and didn't obtaine the Certificate of Chinese medical practitioner;
3. The researcher believes that the subjects are not suitable for participating in clinical trials.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: with Artificial intelligence assistant system; The experiment group would receive the training with the help of artificial intelligence assistant system in addition to the common training. The system is an non-invasive AI system which could help the endoscopists to diagnosis and monitor the blind spot during the gastroscope.	Other: Artificial intelligence assistant system; The intervention is the use of the artificial intelligence assistant system in addition to the common training. The system is an non-invasive AI system which could help the endoscopists to diagnosis and monitor the blind spot during the gastroscope.
No Intervention: without Artificial intelligence assistant system; The control group would receive the training without the help of artificial intelligence assistant system. That is, they would receive the common training process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastroscopy operation score	Using a professional gastroscopy operation scoring scale, the full score is 100 points, and the score is divided into small items. In this experiment, the effect of training between the two groups was compared by comparing the scores of gastroscopy operation in the experimental group and the control group.	three month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coverage rate of blind spots in gastroscopy	Evaluate the gastroscope operation videos retained by each physician during the examination, and calculate the coverage of 26 parts of the gastric mucosa in the experimental group and the control group during the examination. The calculation method is: the coverage rate of the blind area of the gastroscopy = the actual number of parts covered by the examination/26 parts of the stomach x 100%.	three month
Check the average test score before and after training	the difference between the theoretical test score after the training and the theoretical test score before the training, the calculation method: the theoretical test score after the training-the theoretical test score before the training.	three month
Training satisfaction	An AI assistant group fills out a questionnaire after training, and determines the satisfaction with AI assistant training through a grading method.	three month
Detection rate of lesions	the detection rate of lesions in the experimental group and the control group by gastroscopy. Calculation method = number of gastroscopes with detected lesions/total number of gastroscopes completed by beginner physicians x 100%.	three month

Collaborators and Investigators

• Sponsor: Renmin Hospital of Wuhan University
• Investigators: Principal Investigator: Honggang W Yu, Doctor, Renmin Hospital of Wuhan University

Publications and helpful links

General Publications

• Huang L, Liu J, Wu L, Xu M, Yao L, Zhang L, Shang R, Zhang M, Xiong Q, Wang D, Dong Z, Xu Y, Li J, Zhu Y, Gong D, Wu H, Yu H. Impact of Computer-Assisted System on the Learning Curve and Quality in Esophagogastroduodenoscopy: Randomized Controlled Trial. Front Med (Lausanne). 2021 Dec 14;8:781256. doi: 10.3389/fmed.2021.781256. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2020
• Primary Completion (Actual): May 25, 2021
• Study Completion (Actual): June 26, 2021

Study Registration Dates

• First Submitted: December 20, 2020
• First Submitted That Met QC Criteria: December 20, 2020
• First Posted (Actual): December 24, 2020

Study Record Updates

• Last Update Posted (Actual): October 26, 2021
• Last Update Submitted That Met QC Criteria: October 23, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: EA-19-003-19

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