Combination of Artificial Intelligence and Mucosal Exposure Device to Enhance Colorectal Neoplasia Detection

Study Overview
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Brief Summary
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The investigators hypothesize that the combined use of CADe system (ENDOAID) and mucosal exposure device (Endocuff Vision®) would improve the adenoma detection rate when compared to CADe system alone.

Detailed Description
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High polyp miss rates were reported in standard colonoscopies. As a result, a significant proportion of interval CRC was attributed to the missed lesions during index colonoscopy. Risk factors of missed lesions included proximal location, serrate or flat morphology, poor bowel preparation, short withdrawal time and endoscopist experience. To overcome this pitfall, various methods were developed to improve adenoma detection rate (ADR), including distal attachment devices. Among the mucosal exposure devices, Endocuff Vision® was shown to be superior than conventional colonoscopies. Recently, artificial intelligence and automatic computer-aided polyp detection (CADe) systems have developed rapidly and revolutionized the medical field. Nevertheless, there was a potential limitation of 'blind spot' if the endoscopist failed to expose the colonic mucosa adequately leading to missed lesions. To date, no available data or ongoing clinical trial was reported regarding the combined use of CADe and mucosal exposure devices. It may enhance the performance of CADe and provide a novel definitive solution to this unaddressed yet important clinical problem. In this prospective parallel randomized controlled trial, we aim to evaluate the impact of combined use of a new CADe system (ENDOAID) and mucosal exposure device (Endocuff Vision®) on colorectal neoplasia detection.

Official Title
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Combination of Artificial Intelligence (ENDOAID) and Mucosal Exposure Device (ENDOCUFF) to Enhance Colorectal Neoplasia Detection: a Randomized Controlled Trial

Conditions
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Adenoma, Colorectal Cancer, Colorectal Neoplasms

Intervention / Treatment
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* Device: ENDOCUFF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 45-85 years old; They require elective colonoscopy for colorectal cancer screening, polyp surveillance, or investigation of symptoms such as anemia or altered bowel habit; Written informed consent obtained. Exclusion Criteria: Contraindication to colonoscopy (e.g. intestinal obstruction or perforation) Contraindication or conditions precluding polyp resection (e.g. active gastrointestinal bleeding, uninterrupted anticoagulation or dual antiplatelets) Staged procedure for polypectomy or biopsy of known unresected lesions Previous surgical resection of colon Personal history of colorectal cancer Personal history of familial polyposis syndrome Personal history of inflammatory bowel disease Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above) Pregnancy Unable to obtain informed consent

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: ENDOAID<br>CADe system will be used during withdrawal phase of colonoscopy. | |
| Experimental: ENDOAID with ENDOCUFF<br>CADe system and mucosal exposure device (ENDOCUFF) will be used during withdrawal phase of colonoscopy. | Device: ENDOCUFF<br>* ENDOCUFF mucousal exposure device will be used during withdrawal process of the colonoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADR | adenoma detection rate | During the colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADR for adenomas of different sizes | <5mm, 5-10mm, >10mm | During the colonoscopy | 
| ADR for adenomas of different colonic segments | caecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid colon, rectum | During the colonoscopy | 
| Mean number of adenomas per colonoscopy | Mean number of adenomas per colonoscopy | During the colonoscopy | 
| Advanced adenoma detection rate | Advanced adenoma detection rate | During the colonoscopy | 
| Sessile serrated lesion (SSL) detection rate | Sessile serrated lesion (SSL) detection rate | During the colonoscopy | 
| Polyp detection rate | Polyp detection rate | During the colonoscopy | 
| Non-neoplastic resection rate | defined as absence of adenoma or SSL or cancer within resected specimen | During the colonoscopy | 
| Caecal intubation time | Caecal intubation time | During the colonoscopy | 
| Withdrawal time | excluding interventions | During the colonoscopy | 
| Total procedural time | Total procedural time | During the colonoscopy | 
| False positive rate | defined as computer artifacts due to colonic mucosal wall or bowel content lasting for >2 seconds | During the colonoscopy |