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A Study on the Effectiveness of AI-assisted Colonoscopy in Improving the Effect of Colonoscopy Training for Trainees

Primary Purpose

Colonoscopy, Artificial Intelligence, Gastrointestinal Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
artificial intelligence assistance system
Sponsored by
Renmin Hospital of Wuhan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonoscopy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female ≥50 years old;
  2. Able to read, understand and sign informed consent
  3. The investigator believes that the subjects can understand the process of the clinical study, are willing and able to complete all study procedures and follow-up visits, and cooperate with the study procedures
  4. Patients requiring colonoscopy

Exclusion Criteria:

  1. Have drug or alcohol abuse or mental disorder in the last 5 years
  2. Pregnant or lactating women
  3. Patients with known multiple polyp syndrome;
  4. patients with known inflammatory bowel disease;
  5. known intestinal stenosis or space-occupying tumor;
  6. known colon obstruction or perforation;
  7. patients with a history of colorectal surgery;
  8. Patients with previous history of allergy to pre-used spasmolysis;
  9. Unable to perform biopsy and polyp removal due to coagulation disorders or oral anticoagulants;
  10. High risk diseases or other special conditions that the investigator considers the subject unsuitable for participation in the clinical trial.

Sites / Locations

  • Renmin hospital of Wuhan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

with AI-assisted system

without AI-assisted system

Arm Description

The novice doctors are trained in colonoscopy with an artificial intelligence assisted system that can indicate abnormal lesions and the speed of withdrawal in real time, as well as feedback on the percentage of overspeed.

The novice doctors receive routine colonoscopy training without artificial intelligence assistance system and no special tips

Outcomes

Primary Outcome Measures

CUSUM learning curve for colonoscopy (ACE scoring scale)
Average test score difference before and after training

Secondary Outcome Measures

Detection rate of advanced adenoma
The numerator is the number of patients diagnosed with advanced adenomas, and the denominator is the total number of patients undergoing colonoscopy,Advanced adenoma was defined as > 10mm adenoma, villous adenoma, tubular villous adenoma, high-grade intraepithelial neoplasia, and carcinoma.
Polyp Detection Rate, PDR
The numerator is the number of patients with polyps detected by colonoscopy, and the denominator is the total number of patients who underwent colonoscopy
Average number of adenomas detected per patient
The numerator is the total number of adenomas detected by colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
The detection rate of large, small and micro polyps
The numerator is the number of patients with large (≥10 mm), small (6-9 mm) and micro-small (≤5 mm) polyps detected by colonoscopy, and the denominator is the total number of patients receiving colonoscopy.
The average number of large, small and micro polyps detected
The numerator is the total number of large (≥10 mm), small (6-9 mm) and micro-small (≤5 mm) polyps detected by colonoscopy, and denominator is the total number of patients undergoing colonoscopy.
The detection rate of large, small and micro adenomas
The numerator is the number of patients with large (≥10 mm), small (6-9 mm) and micro-small (≤5 mm) adenomas detected by colonoscopy, and the denominator is the total number of patients receiving colonoscopy.
The average number of large, small and micro adenomas detected
The numerator is the total number of large (≥10 mm), small (6-9 mm) and micro-small (≤5 mm) adenomas detected by colonoscopy, and denominator is the total number of patients undergoing colonoscopy.
The detection rate of adenoma in different sites
The numerator is the number of patients with adenomas detected in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon, ileocecal region and other sites during colonoscopy, and the denominator is the total number of patients receiving colonoscopy.
The average number of adenomas detected in different sites
The numerator is the total number of adenomas detected in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon, ileocecal region and other sites during colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
Number of missed return of the sliding endoscopy/number of successful return of the sliding endoscopy
The numerator is the total number of sliding endoscopy during colonoscopy, and the denominator is the number of sliding endoscopy and successful return endoscopy during colonoscopy
Real-time gut cleanliness score
During colonoscopy, a real-time intestinal cleanliness score was given by EndoAngel based on the Boston-scale Boreal Preparation Score (BBPS).
withdraw overspeed percentage
The ratio of the overspeed duration to the total duration in the process of withdrawal.
The withdraw time
The time between colonoscopy arrival at ileocecal valve and colonoscopy exit from anus.
Ratio of ileocecal reach
For a period of time, the number of colonoscopies that failed to reach the ileocecal part accounted for the proportion of the total number of colonoscopies.

Full Information

First Posted
May 28, 2021
Last Updated
May 28, 2021
Sponsor
Renmin Hospital of Wuhan University
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1. Study Identification

Unique Protocol Identification Number
NCT04912037
Brief Title
A Study on the Effectiveness of AI-assisted Colonoscopy in Improving the Effect of Colonoscopy Training for Trainees
Official Title
A Study on the Effectiveness of Artificial Intelligence-assisted Colonoscopy in Improving the Effect of Colonoscopy Training for Trainees
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Anticipated)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
February 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Renmin Hospital of Wuhan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
In this study,the AI-assisted system(EndoAngel)has the functions of reminding the ileocecal junction, withdrawal time, withdrawal speed, sliding lens, polyps in the field of vision, etc. These functions can improve the colonoscopy performance of novice physicians and assist the colonoscopy training。
Detailed Description
Colonoscopy is a key technique for detecting and diagnosing lesions of the lower digestive tract.High-quality endoscopy leads to better disease outcomes.However, the demand for endoscopy is high in China, and endoscopy is in short supply.A colonoscopy is a complex technical procedure that requires training and experience for maximal accuracy and safety.Therefore, it is of great significance to improve the colonoscopy ability of novice physicians and shorten the colonoscopy training time for solving the problems such as the lack and uneven distribution of digestive endoscopists and the substandard quality of endoscopy in China. In recent years, deep learning algorithms have been continuously developed and increasingly mature.They have been gradually applied to the medical field. Computer vision is a science that studies how to make machines "see". Through deep learning, camera and computer can replace human eyes to carry out machine vision such as target recognition, tracking and measurement.Interdisciplinary cooperation in the field of medical imaging and computer vision is also one of the research hotspots in recent years. At present, it is mainly applied to the automatic identification and detection of lesions and quality control, and has achieved good results. Our preliminary experiments have shown that deep learning has a high accuracy in endoscopic quality monitoring, which can effectively regulate doctors' operations, reduce blind spots and improve the quality of endoscopic examination.At the same time, it can also monitor the doctor's withdrawal time in real time and improve the detection rate of adenoma.In the previous work of our research group, we have successfully developed deep learning-based colonoscopy withdraw speed monitoring and intestinal cleanliness assessment, and verified the effectiveness of the AI-assisted system(EndoAngel) in improving the quality of gastroscopy and colonoscopy in clinical trials. Based on the above rich foundation of preliminary work, as well as the huge demand in the field of colonoscopy training,By comparing the colonoscopy operation training for novices with and without EndoAngel assistance, we plan to compare the colonoscopy learning effect of novices with and without assistance, including skill results and cognitive level, to explore whether AI can promote the improvement of the colonoscopy operation training for novices.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonoscopy, Artificial Intelligence, Gastrointestinal Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
385 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
with AI-assisted system
Arm Type
Experimental
Arm Description
The novice doctors are trained in colonoscopy with an artificial intelligence assisted system that can indicate abnormal lesions and the speed of withdrawal in real time, as well as feedback on the percentage of overspeed.
Arm Title
without AI-assisted system
Arm Type
No Intervention
Arm Description
The novice doctors receive routine colonoscopy training without artificial intelligence assistance system and no special tips
Intervention Type
Device
Intervention Name(s)
artificial intelligence assistance system
Intervention Description
the artificial intelligence assistance system can indicate abnormal lesions and real-time withdrawal speed, and feedback the overspeed percentage.
Primary Outcome Measure Information:
Title
CUSUM learning curve for colonoscopy (ACE scoring scale)
Time Frame
From the beginning to the end of colonoscopy training
Title
Average test score difference before and after training
Time Frame
From the beginning to the end of colonoscopy training
Secondary Outcome Measure Information:
Title
Detection rate of advanced adenoma
Description
The numerator is the number of patients diagnosed with advanced adenomas, and the denominator is the total number of patients undergoing colonoscopy,Advanced adenoma was defined as > 10mm adenoma, villous adenoma, tubular villous adenoma, high-grade intraepithelial neoplasia, and carcinoma.
Time Frame
A month
Title
Polyp Detection Rate, PDR
Description
The numerator is the number of patients with polyps detected by colonoscopy, and the denominator is the total number of patients who underwent colonoscopy
Time Frame
A month
Title
Average number of adenomas detected per patient
Description
The numerator is the total number of adenomas detected by colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
Time Frame
A month
Title
The detection rate of large, small and micro polyps
Description
The numerator is the number of patients with large (≥10 mm), small (6-9 mm) and micro-small (≤5 mm) polyps detected by colonoscopy, and the denominator is the total number of patients receiving colonoscopy.
Time Frame
A month
Title
The average number of large, small and micro polyps detected
Description
The numerator is the total number of large (≥10 mm), small (6-9 mm) and micro-small (≤5 mm) polyps detected by colonoscopy, and denominator is the total number of patients undergoing colonoscopy.
Time Frame
A month
Title
The detection rate of large, small and micro adenomas
Description
The numerator is the number of patients with large (≥10 mm), small (6-9 mm) and micro-small (≤5 mm) adenomas detected by colonoscopy, and the denominator is the total number of patients receiving colonoscopy.
Time Frame
A month
Title
The average number of large, small and micro adenomas detected
Description
The numerator is the total number of large (≥10 mm), small (6-9 mm) and micro-small (≤5 mm) adenomas detected by colonoscopy, and denominator is the total number of patients undergoing colonoscopy.
Time Frame
A month
Title
The detection rate of adenoma in different sites
Description
The numerator is the number of patients with adenomas detected in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon, ileocecal region and other sites during colonoscopy, and the denominator is the total number of patients receiving colonoscopy.
Time Frame
A month
Title
The average number of adenomas detected in different sites
Description
The numerator is the total number of adenomas detected in the rectum, sigmoid colon, descending colon, transverse colon, ascending colon, ileocecal region and other sites during colonoscopy, and the denominator is the total number of patients undergoing colonoscopy.
Time Frame
A month
Title
Number of missed return of the sliding endoscopy/number of successful return of the sliding endoscopy
Description
The numerator is the total number of sliding endoscopy during colonoscopy, and the denominator is the number of sliding endoscopy and successful return endoscopy during colonoscopy
Time Frame
A month
Title
Real-time gut cleanliness score
Description
During colonoscopy, a real-time intestinal cleanliness score was given by EndoAngel based on the Boston-scale Boreal Preparation Score (BBPS).
Time Frame
During procedure
Title
withdraw overspeed percentage
Description
The ratio of the overspeed duration to the total duration in the process of withdrawal.
Time Frame
During procedure
Title
The withdraw time
Description
The time between colonoscopy arrival at ileocecal valve and colonoscopy exit from anus.
Time Frame
During procedure
Title
Ratio of ileocecal reach
Description
For a period of time, the number of colonoscopies that failed to reach the ileocecal part accounted for the proportion of the total number of colonoscopies.
Time Frame
A month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female ≥50 years old; Able to read, understand and sign informed consent The investigator believes that the subjects can understand the process of the clinical study, are willing and able to complete all study procedures and follow-up visits, and cooperate with the study procedures Patients requiring colonoscopy Exclusion Criteria: Have drug or alcohol abuse or mental disorder in the last 5 years Pregnant or lactating women Patients with known multiple polyp syndrome; patients with known inflammatory bowel disease; known intestinal stenosis or space-occupying tumor; known colon obstruction or perforation; patients with a history of colorectal surgery; Patients with previous history of allergy to pre-used spasmolysis; Unable to perform biopsy and polyp removal due to coagulation disorders or oral anticoagulants; High risk diseases or other special conditions that the investigator considers the subject unsuitable for participation in the clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu W Honggang, Doctor
Phone
+862788041911
Email
whdxrmyy@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Honggang, Doctor
Phone
+862788041911
Email
whdxrmyy@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu w Honggang, Doctor
Organizational Affiliation
Renmin Hospital of Wuhan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renmin hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Honggang Yu, Doctor
Phone
+862788041911
Email
whdxrmyy@126.com

12. IPD Sharing Statement

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A Study on the Effectiveness of AI-assisted Colonoscopy in Improving the Effect of Colonoscopy Training for Trainees

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