Adenoma, Colorectal Cancer, Colorectal Neoplasms
Conditions
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.
Interventions
DEVICEENDOCUFF
ENDOCUFF mucousal exposure device will be used during withdrawal process of the colonoscopy.
Sponsors
University Hospital Augsburg
Changi General Hospital
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Aged 45-85 years old; 2. They require elective colonoscopy for colorectal cancer screening, polyp surveillance, or investigation of symptoms such as anemia or altered bowel habit; 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, uninterrupted anticoagulation or dual antiplatelets) 3. Staged procedure for polypectomy or biopsy of known unresected lesions 4. Previous surgical resection of colon 5. Personal history of colorectal cancer 6. Personal history of familial 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ADR | During the colonoscopy | adenoma detection rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 serrated lesion (SSL) detection rate | During the colonoscopy | Sessile serrated lesion (SSL) detection rate |
| Polyp detection rate | During the colonoscopy | Polyp detection rate |
| ADR for adenomas of different sizes | During the colonoscopy | \<5mm, 5-10mm, \>10mm |
| Caecal intubation time | During the colonoscopy | Caecal intubation time |
| Withdrawal time | During the colonoscopy | excluding interventions |
| Total procedural time | During the colonoscopy | Total procedural time |
| False positive rate | During the colonoscopy | defined as computer artifacts due to colonic mucosal wall or bowel content lasting for \>2 seconds |
| Non-neoplastic resection rate | During the colonoscopy | defined as absence of adenoma or SSL or cancer within resected specimen |
Countries
Hong Kong
Contacts
Primary ContactFelix Sia
Backup ContactThomas Lam
Outcome results
None listed