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

Not Applicable

Recruiting

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

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

Locations (1): Prince of Wales Hospital
🇭🇰
Shatin, Hong Kong Island, Hong Kong