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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
1,726
ENDOCUFF mucousal exposure device will be used during withdrawal process of the colonoscopy.
Prince of Wales Hospital
Shatin, Hong Kong Island, Hong Kong
ADR
adenoma detection rate
Time frame: During the colonoscopy
ADR for adenomas of different sizes
\<5mm, 5-10mm, \>10mm
Time frame: During the colonoscopy
ADR for adenomas of different colonic segments
caecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid colon, rectum
Time frame: During the colonoscopy
Mean number of adenomas per colonoscopy
Mean number of adenomas per colonoscopy
Time frame: During the colonoscopy
Advanced adenoma detection rate
Advanced adenoma detection rate
Time frame: During the colonoscopy
Sessile serrated lesion (SSL) detection rate
Sessile serrated lesion (SSL) detection rate
Time frame: During the colonoscopy
Polyp detection rate
Polyp detection rate
Time frame: During the colonoscopy
Non-neoplastic resection rate
defined as absence of adenoma or SSL or cancer within resected specimen
Time frame: During the colonoscopy
Caecal intubation time
Caecal intubation time
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Time frame: During the colonoscopy
Withdrawal time
excluding interventions
Time frame: During the colonoscopy
Total procedural time
Total procedural time
Time frame: During the colonoscopy
False positive rate
defined as computer artifacts due to colonic mucosal wall or bowel content lasting for \>2 seconds
Time frame: During the colonoscopy