Clinical trial NCT05414448: Combination of Artificial Intelligence and Mucosal Exposure Device to Enhance Colorectal Neoplasia Detection
Official title: Combination of Artificial Intelligence (ENDOAID) and Mucosal Exposure Device (ENDOCUFF) to Enhance Colorectal Neoplasia Detection: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adenoma
Colorectal Cancer
Colorectal Neoplasms
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: University Hospital Augsburg
name: Changi General Hospital
First posted: 2022-06-10
Enrollment: 1726
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: ADR
timeFrame: During the colonoscopy
Secondary outcomes:
measure: ADR for adenomas of different sizes
timeFrame: During the colonoscopy
measure: ADR for adenomas of different colonic segments
timeFrame: During the colonoscopy
measure: Mean number of adenomas per colonoscopy
timeFrame: During the colonoscopy
measure: Advanced adenoma detection rate
timeFrame: During the colonoscopy
measure: Sessile serrated lesion (SSL) detection rate
timeFrame: During the colonoscopy
measure: Polyp detection rate
timeFrame: During the colonoscopy
measure: Non-neoplastic resection rate
timeFrame: During the colonoscopy
measure: Caecal intubation time
timeFrame: During the colonoscopy
measure: Withdrawal time
timeFrame: During the colonoscopy
measure: Total procedural time
timeFrame: During the colonoscopy
measure: False positive rate
timeFrame: During the colonoscopy
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
state: Hong Kong Island
Study officials:
References: