Does AI-assisted Colonoscopy Improve Adenoma Detection in Screening Colonoscopy?
Primary Purpose
Screening Colonoscopy
Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
AI-assisted Colonoscopy
Standard Colonoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Screening Colonoscopy
Eligibility Criteria
Inclusion Criteria
- Patients receiving colonoscopy screening
- Patients aged 45-75 years
- Both patients who have or have not done a FIT test and both FIT +ve and FIT -ve subjects
Exclusion Criteria
- Patients who have symptom(s) suggestive of colorectal diseases
- Patients who have a history of inflammatory bowel disease, colorectal cancer or polyposis syndrome (anaemia, bloody stool, tenesmus and obstructive symptoms)
- Patients who had colonoscopy or other investigation of colon and rectum in the past 10 years
- Patients who had surgery for colorectal diseases
- Patients who cannot tolerate bowel preparation or have suboptimal bowel preparations (Boston Bowel Preparation Scale)
- Cannot reach caecum
- Patients who are incompetent in giving informed consent
Sites / Locations
- Prince of Wales HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
AI-assisted Group
Standard
Arm Description
Outcomes
Primary Outcome Measures
Per-patient ADR in each group
For the AI-Assisted group, it is defined as the number of patients with at least 1 adenoma identified in the colon divided by the total number of patients in the AI-Assisted group.
Per-patient ADR in each group
For the Standard group, it is defined as the number of patients with at least 1 adenoma identified in the colon divided by the total number of patients in the Standard group.
Secondary Outcome Measures
Full Information
NCT ID
NCT04422548
First Posted
June 5, 2020
Last Updated
July 14, 2020
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04422548
Brief Title
Does AI-assisted Colonoscopy Improve Adenoma Detection in Screening Colonoscopy?
Official Title
Does AI-assisted Colonoscopy Improve Adenoma Detection in Screening Colonoscopy? A Multi-center Randomized Controlled
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 28, 2019 (Actual)
Primary Completion Date
November 27, 2020 (Anticipated)
Study Completion Date
November 27, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
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
To date, there is a lack of large-scale randomized controlled study using AI assistance in the detection of polyps/adenoma in a screening population. The correlation of fecal occult blood test (FIT or FOBT) and the advantage of AI-assisted colonoscopy has not been investigated. There is also a lack of information of the benefit of AI-assisted colonoscopy in experienced colonoscopist versus trainee/resident.
Detailed Description
There are several studies showing that AI-assisted colonoscopy can help in identifying and characterizing polyps found on colonoscopy.
Byrne et al demonstrated that their AI model for real-time assessment of endoscopic video images of colorectal polyp can differentiate between hyperplastic diminutive polyps vs adenomatous polyps with sensitivity of 98% and specificity of 83% (Byrne et al. GUT 2019)
Urban et al designed and trained deep CNNs to detect polyps in archived video with a ROC curve of 0.991 and accuracy of 96.4%. The total number of polyps identified is significantly higher but mainly in the small (1-3mm and 4-6mm polyps) (Urban et al. Gastroenterol 2018)
Wang et al conducted an open, non-blinded trial consecutive patients (n=1058) prospectively randomized to undergo diagnostic colonoscopy with or without AI assistance. They found that AI system increased ADR from 20.3% to 29.1% and the mean number of adenomas per patients from 0.31 to 0.53. This was due to a higher number of diminutive polyps found while there was no statistic difference in larger adenoma. (Wang et al. GUT 2019). In this study, they excluded patients with IBD, CRC and colorectal surgery. The patients presented with symptoms to hospital for investigation.
To date, there is a lack of large-scale randomized controlled study using AI assistance in the detection of polyps/adenoma in a screening population. The correlation of fecal occult blood test (FIT or FOBT) and the advantage of AI-assisted colonoscopy has not been investigated. There is also a lack of information of the benefit of AI-assisted colonoscopy in experienced colonoscopist versus trainee/resident.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Screening Colonoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2994 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AI-assisted Group
Arm Type
Active Comparator
Arm Title
Standard
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
AI-assisted Colonoscopy
Intervention Description
This is a multi-center prospective randomized controlled study comparing real-time AI-assisted colonoscopy versus standard colonoscopy in a real-life setting.
Intervention Type
Procedure
Intervention Name(s)
Standard Colonoscopy
Intervention Description
Standard Colonoscopy
Primary Outcome Measure Information:
Title
Per-patient ADR in each group
Description
For the AI-Assisted group, it is defined as the number of patients with at least 1 adenoma identified in the colon divided by the total number of patients in the AI-Assisted group.
Time Frame
12 months
Title
Per-patient ADR in each group
Description
For the Standard group, it is defined as the number of patients with at least 1 adenoma identified in the colon divided by the total number of patients in the Standard group.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
Patients receiving colonoscopy screening
Patients aged 45-75 years
Both patients who have or have not done a FIT test and both FIT +ve and FIT -ve subjects
Exclusion Criteria
Patients who have symptom(s) suggestive of colorectal diseases
Patients who have a history of inflammatory bowel disease, colorectal cancer or polyposis syndrome (anaemia, bloody stool, tenesmus and obstructive symptoms)
Patients who had colonoscopy or other investigation of colon and rectum in the past 10 years
Patients who had surgery for colorectal diseases
Patients who cannot tolerate bowel preparation or have suboptimal bowel preparations (Boston Bowel Preparation Scale)
Cannot reach caecum
Patients who are incompetent in giving informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Ming Yeung HO
Phone
26371398
Email
andrewho@cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Yuen Tung LAM
Phone
26370355
Email
thomaslam@cuhk.edu.hk
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Yeung HO
Phone
26371398
Email
andrewho@cuhk.edu.hk
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35863686
Citation
Xu H, Tang RSY, Lam TYT, Zhao G, Lau JYW, Liu Y, Wu Q, Rong L, Xu W, Li X, Wong SH, Cai S, Wang J, Liu G, Ma T, Liang X, Mak JWY, Xu H, Yuan P, Cao T, Li F, Ye Z, Shutian Z, Sung JJY. Artificial Intelligence-Assisted Colonoscopy for Colorectal Cancer Screening: A Multicenter Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2023 Feb;21(2):337-346.e3. doi: 10.1016/j.cgh.2022.07.006. Epub 2022 Jul 19.
Results Reference
derived
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Does AI-assisted Colonoscopy Improve Adenoma Detection in Screening Colonoscopy?
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