Artificial Intelligence-assisted Colonoscopy With or Without Endocuff Vision

Study Overview
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Brief Summary
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Adenoma detection rate (ADR) is considered the single most important quality measure in colonoscopy and a higher ADR can reduce the risk of interval colorectal cancer (CRC). Several kinds of new endoscopes and accessories have been accessed to investigate the abilities of improving the ADR. Artificial intelligence (AI) and Endocuff vision are promising new devices to improve the ADR. However, the effect of combining AI and Endocuff vision on ADR remains unclear. The aim of this prospective randomized study is to compare the ADR of AI plus Endocuff vision, AI alone and standard colonoscopy examination.

Detailed Description
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This is a prospective single-blinded randomized controlled trial of three different types of colonoscopy examinations by 1:1:1 ratio. We use EndoAim AI (ASUS, Taiwan) and Endocuff vision (Olympus, UK) assisted colonoscopy in the first group. We use AI assisted colonoscopy in the 2nd group. We use standard colonoscopy in the 3rd group. Eligible patients are older than 40 years old and receive colonoscopy for either symptomatic or screening/surveillance. All endoscopists should receive training on EndoAim AI systems and Endocuff vision. During the procedure, experienced endoscopists use high-definition endoscopes (EVIS-EXERA 290 video system, Olympus Optical, Aizu, Japan) under white light and insert to the cecum in the three different groups. The cecal intubation is confirmed by the identification of ileocecal valve and appendiceal orifice. The Boston Bowel Preparation Scale is used for grading the bowel preparation quality. The size (compared with biopsy forceps), location and morphology of polyps are recorded by the independent endoscopist. All polyps ae removed by either biopsy or polypectomy. The insertion and withdrawal time are measured. The time of the polypectomy site is not included in the withdrawal time.

Official Title
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Comparison of The Adenoma Detection Rate Between Artificial Intelligence-assisted Colonoscopy With or Without Endocuff Vision and Standard Colonscopy: A Randomized Controlled Study

Conditions
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Adenoma Detection Rate

Intervention / Treatment
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* Device: Artificial intelligence
* Device: Endocuff vision
* Device: High-definition endoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 20 years old are undergoing outpatient sedative colonoscopy in the E-Da Hospital, E-Da cancer Hospital and Chung Shan Medical University Hospital in Taiwan Exclusion Criteria: A prior history of of inflammatory bowel disease, colorectal cancer, previous bowel resection, Peutz-Jeghers syndrome, familial adenomatous polyposis or other polyposis syndromes Bleeding tendency For scheduled endoscopic treatment

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Artificial Intelligence-assisted Colonoscopy with Endocuff Vision<br>Use artificial intelligence-assisted colonoscopy with Endocuff Vision | Device: Artificial intelligence<br>* ASUS EndoAim AI Endoscopy System (ASUS, Taiwan) is used to help the detection of colon adenoma<br>Device: Endocuff vision<br>* Endocuff vision (Olympus, UK) is used to help the detection of colon adenoma<br>Device: High-definition endoscope<br>* High-definition endoscope (EVIS-EXERA 290 video system, Olympus Optical, Aizu, Japan) is used under white light for the detection of colon adenoma<br>|
| Active Comparator: Artificial Intelligence-assisted Colonoscopy<br>Use artificial intelligence-assisted colonoscopy alone | Device: Artificial intelligence<br>* ASUS EndoAim AI Endoscopy System (ASUS, Taiwan) is used to help the detection of colon adenoma<br>Device: High-definition endoscope<br>* High-definition endoscope (EVIS-EXERA 290 video system, Olympus Optical, Aizu, Japan) is used under white light for the detection of colon adenoma<br>|
| Sham Comparator: Standard colonoscopy<br>Use standard colonoscopy without artificial intelligence-assisted colonoscopy or Endocuff Vision | Device: High-definition endoscope<br>* High-definition endoscope (EVIS-EXERA 290 video system, Olympus Optical, Aizu, Japan) is used under white light for the detection of colon adenoma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate | The proportion of patients with at least one adenomas | One month after colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyp detection rate | The proportion of patients with at least one polyp | One month after colonoscopy | 
| Sessile serrated adenoma detection rate | The proportion of patients with at least one sessile serrated adenoma | One month after colonoscopy | 
| Sessile serrated polyps detection rate | The proportion of patients with at least one sessile serrated polyp | One month after colonoscopy | 
| Advanced adenoma detection rate | The proportion of patients with at least one advanced adenoma | One month after colonoscopy | 
| Mean number of polyp per patient | The mean number of polyp per patient | One month after colonoscopy | 
| Mean number of adenoma per patient | The mean number of adenoma per patient | One month after colonoscopy | 
| Total number of polyp or adenoma per patient | The total number of polyp or adenoma per patient | One month after colonoscopy |