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

Not Applicable

Completed

• Conditions: Screening Colonoscopy
• Interventions: Device: ENDO-AID CADe

• Registration Number: NCT04838951
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-03-23
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-09
• Study Start: 2021-04-19
• Primary Completion: 2022-07-22
• Study Completion: 2022-12-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 856

Inclusion Criteria

1. Aged 18 years old or above;
2. They require elective colonoscopy for colorectal cancer screening, polyp surveillance, or investigation of symptoms such as anemia or gastrointestinal bleeding;
3. Written informed consent obtained.

Exclusion Criteria

1. Contraindication to colonoscopy (e.g. intestinal obstruction or perforation)
2. Contraindication or conditions precluding polyp resection (e.g. active gastrointestinal bleeding, significant bleeding tendency, uninterrupted anticoagulation or dual antiplatelets)
3. Scheduled staged procedure for polypectomy or biopsy
4. Previous colonic resection
5. Personal history of colorectal cancer
6. Personal history of polyposis syndrome
7. Personal history of inflammatory bowel disease
8. Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above)
9. Pregnancy
10. Unable to obtain informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	ENDO-AID CADe	CADe system will be used during withdrawal phase of colonoscopy.

Primary Outcome Measures

Name	Time	Method
ADR	During the colonoscopy	adenoma detection rate

Secondary Outcome Measures

Name	Time	Method
Total procedural time	During the colonoscopy	Total procedural time
ADR for adenomas of different sizes	During the colonoscopy	\<5mm, 5-10mm, \>10mm
ADR for adenomas of different colonic segments	During the colonoscopy	caecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid colon, rectum
Mean number of adenomas per colonoscopy	During the colonoscopy	Mean number of adenomas per colonoscopy
Advanced adenoma detection rate	During the colonoscopy	Advanced adenoma detection rate
Sessile serrate lesion (SSL) detection rate	During the colonoscopy	Sessile serrate lesion (SSL) detection rate
Polyp detection rate	During the colonoscopy	Polyp detection rate
Non-neoplastic resection rate	During the colonoscopy	defined as absence of adenoma or SSL within resected specimen
Missed polyp rate	During the colonoscopy	defined as a polyp which the junior endoscopist fails to recognize and withdraws the endoscope to next colonic segment, but detected by the supervisor
False positive rate	During the colonoscopy	defined as computer artifacts due to colonic mucosal wall or bowel content lasting for \>2 seconds
Cecal intubation time	During the colonoscopy	Cecal intubation time
Withdrawal time	During the colonoscopy	excluding interventions
Percentage of change in ADR in relation to the personal experience in colonoscopy	During the colonoscopy	Percentage of change in ADR in relation to the personal experience in colonoscopy based on number of procedures performed \<200 vs 200-500

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Shatin, New Territories, Hong Kong