Does AI-assisted Colonoscopy Improve Adenoma Detection in Screening Colonoscopy?

Screening Colonoscopy Clinical Trial

Official title:

Does AI-assisted Colonoscopy Improve Adenoma Detection in Screening Colonoscopy? A Multi-center Randomized Controlled

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04422548
• Other study ID #: AI-CLN Study_Protocol
• Status: Recruiting
• Phase: N/A
• Start date: November 28, 2019
• Est. completion date: November 27, 2020

Study information

• Verified date: July 2020
• Source: Chinese University of Hong Kong
• Contact: Andrew Ming Yeung HO
• Phone: 26371398
• Email: andrewho[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2994
• Est. completion date: November 27, 2020
• Est. primary completion date: November 27, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Screening Colonoscopy

Intervention

Procedure:
• AI-assisted Colonoscopy
This is a multi-center prospective randomized controlled study comparing real-time AI-assisted colonoscopy versus standard colonoscopy in a real-life setting.
• Standard Colonoscopy
Standard Colonoscopy

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Primary	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.	12 months