Effect of Real-time Computer-aided System (ENDO-AID) on Adenoma Detection in Endoscopist-in-training

Study Overview
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Brief Summary
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The investigator's hypothesis is that a CADe system (ENDO-AID) would improve the adenoma detection rate in junior endoscopists.

Detailed Description
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Colorectal cancer (CRC) is the most common and second most lethal cancer in Hong Kong with more than 5,600 new cases and 2,300 deaths annually. Colonoscopy with polypectomy has shown to reduce CRC-related mortality by 53%. However, high polyp miss rates were reported to be up to 26% for adenomas and 9% for advanced adenomas in standard colonoscopies. Risk factors included proximal location, serrate or flat lesions, poor bowel preparation and short withdrawal time (<6 minutes). Insufficient trainee experience was also associated with a higher adenoma miss rate. A significant proportion of interval CRC was attributed to the missed lesions during index colonoscopy leading to adverse patient outcomes. As a result, various techniques were developed to improve adenoma detection rate (ADR) during colonoscopies. Techniques including water exchange method, second examination of the right colon (retroflexion or second forward view)and cap/cuff-assisted colonoscopies were proven to increase ADR effectively. However, these techniques were operator-dependent requiring certain level of expertise. Recently, artificial intelligence and computer-aided polyp detection (CADe) systems have developed rapidly around the globe. These systems can provide real-time CADe by flagging the suspected lesions to endoscopists, with the adoption of deep learning or convoluted neural networks. A number of prospective randomized clinical trials reported a significant increase in ADR in CADe group. The number of adenoma detected per colonoscopy was consistently higher among different polyp sizes, location and morphology. The ADR increment was particularly higher for diminutive adenomas smaller than 5mm. Nevertheless, most of the aforementioned studies only involved senior endoscopists for the procedures. Theoretically, the senior endoscopists were more skillful to expose colonic mucosa and more experienced to distinguish the false positive computer signals, leading to an enhanced performance of CADe in real-time colonoscopies. The effect of CADe on inexperienced junior endoscopists performing colonoscopies remains largely unknown. In this single-blind randomized study, the investigators aim to evaluate the effect of a new CADe system (ENDO-AID) on adenoma detection and quality improvement in junior endoscopists.

Official Title
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Effect of Real-time Computer-aided System (ENDO-AID) on Adenoma Detection in Endoscopist-in-training: a Single-blind Randomized Study

Conditions
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Screening Colonoscopy

Intervention / Treatment
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* Device: ENDO-AID CADe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years old or above; They require elective colonoscopy for colorectal cancer screening, polyp surveillance, or investigation of symptoms such as anemia or gastrointestinal bleeding; 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, significant bleeding tendency, uninterrupted anticoagulation or dual antiplatelets) Scheduled staged procedure for polypectomy or biopsy Previous colonic resection Personal history of colorectal cancer Personal history of 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: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>CADe system will be used during withdrawal phase of colonoscopy. | Device: ENDO-AID CADe<br>* ENDO-AID CADe will be used during the withdrawal process of the colonoscopy.<br>|
| No Intervention: Control arm<br>Colonoscopy will be performed according to hospital protocol. | |

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 serrate lesion (SSL) detection rate | Sessile serrate 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 within resected specimen | During the colonoscopy | 
| Missed polyp rate | defined as a polyp which the junior endoscopist fails to recognize and withdraws the endoscope to next colonic segment, but detected by the supervisor | 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 | 
| Cecal intubation time | Cecal intubation time | During the colonoscopy | 
| Withdrawal time | excluding interventions | During the colonoscopy | 
| Total procedural time | Total procedural time | During the colonoscopy | 
| Percentage of change in ADR in relation to the personal experience in colonoscopy | Percentage of change in ADR in relation to the personal experience in colonoscopy based on number of procedures performed <200 vs 200-500 | During the colonoscopy |