Adenoma Detection Rate Using AI System in China

Study Overview
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Brief Summary
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The primary aim of this study is - to explore the usefulness of Artificial Intelligence system in colonoscopy on adenoma detection rate (ADR). Other aims include to explore the data below when Artificial Intelligence is used. Mean adenomas detected per procedure, MAP Proximal Adenoma detection rate, pADR Polyp detection rate, PDR Proximal polyp detection rate, pPDR Mean polyps detected per procedure, MPP Withdrawal time, WT Cecal intubation rate, CIR Cecal intubation time, CIT

Detailed Description
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Colorectal cancer is common in China. Most colorectal cancers happen when an adenoma becomes cancerous. Doctors use colonoscopy to look inside the colon and rectum and find adenomas and remove them. Removing adenomas is known to reduce the chances of a person developing colorectal cancers. The ability of colonoscopists finding adenomas varies, and there is a lot of researches into how to improve adenoma detection rates. A new AI system, called the CSK endoscopic diagnosis and treatment system has been designed to improve the rate of polyp detection at colonoscopy. Previous tests have shown that there is a significant improvement in detection of adenomas when the system is used. This study will randomize patients coming for colonoscopy to have their procedure performed as usual or as an AI-assisted colonoscopy. The investigators will record polyp and adenoma detection rates, duration of procedure, participant comfort levels, and complications. All patients referred for colonoscopy will be invited in 4 centers, recruiting a total of 800 participants.

Official Title
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Adenoma Detection Rate Using Artificial Intelligence System in China

Conditions
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Colorectal Neoplasms, Colonic Polyp, Adenoma

Intervention / Treatment
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* Device: CSK AI system
* Device: Standard Colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients referred for screening, surveillance, or diagnostic colonoscopy All patients must be able to give informed consent Exclusion Criteria: Patients with any absolute contraindications to colonoscopy Patients with established or suspicion of large bowel obstruction or pseudo-obstruction Patients with known colon cancer or polyposis syndromes Patients with known colonic strictures Patients with known severe diverticular segments (that is likely to impede colonoscope passage) Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis) Patients lacking capacity to give informed consent Pregnancy Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure. Patients who are attending for a therapeutic procedure or assessment of a known lesion

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: CSK endoscopic diagnosis and treatment system a new system of artificial intelligence. It is manufactured by Tianjin Yujin Limited in China. It is equipped with the endoscopic mainframe and has the access to the endoscopic video and image. When lesion-like objects appear in the real-time video, the system will alarm the examiners by sound.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AI-assisted Colonoscopy<br>Participants in this arm undergo AI-assisted colonoscopy using CSK AI system. | Device: CSK AI system<br>* CSK system is equipped with the endoscopic mainframe and alarms the examiners when suspect lesions appear.<br>|
| Active Comparator: Standard Colonoscopy<br>Participants in this arm undergo standard colonoscopy. | Device: Standard Colonoscopy<br>* This is the routine examination in nowadays clinical practice. Both the equipment and the procedure are as usual as clinical routine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate, ADR | ADR refer to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma. | At the end of the procedure, up to 1 hour. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyp detection rate, PDR | PDR refer to the rate of polyp detection, calculated as the proportion of subjects with at least one polyp. | At the end of the procedure, up to 1 hour. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenoma detection rate