Endocuff With or Without AI-assisted Colonoscopy

Study Overview
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Brief Summary
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Colonoscopy is considered the gold standard for diagnosis of colonic polyps. However, it was reported that colonoscopy could still miss colonic polyps. Many attempts have been made to improve the detection rate of colonoscopy. Artificial intelligence (AI) is a promising new technique to improve detection rate of colonic adenoma. However, it remains uncertain whether whether the combined use of Endocuff and AI assisted examination could help to further improve the adenoma detection rate. This is a prospective randomized trial comparing the use of endocuff with AI, AI alone or conventional colonoscopy examination on adenoma detection rate.

Detailed Description
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TThis is a prospective randomized tandem colonoscopy trial comparing three different modes of colonoscopy techniques. The first group will use Endocuff (Olympus, Hong Kong) and AI assisted colonoscopy. The second group will use AI assisted colonoscopy alone and the third group will use standard high-definition white light colonoscopy. Eligible patients will be randomly allocated in a 1:1:1 ratio to three groups. Patients will be stratified according to indications of colonoscopy (symptomatic vs screening/surveillance). All examination will be performed with high-definition endoscopes (EVIS-EXERA 290 video system, Olympus Optical, Tokyo, Japan) under white light by experienced endoscopists. All endoscopists should have received training on the interpretation of real-time AI detection system as well as the Endocuff before performing study colonoscopy. In all colonoscopy examination, colonoscope will be first advanced to the cecum as confirmed by identification of the appendiceal orifice and ileocecal valve or by intubation of the ileum. After cecal intubation is performed, the colonoscopy is first withdrawn according to the group assigned. For group 1, the first withdrawal would be done with Endocuff and AI assistance. For group 2, the first withdrawal would be done under AI assistance only. For group 3, the first withdrawal would be done under standard high definition colonoscopy only. All detected polyps will be removed during the withdrawal only. The size (measured with biopsy forceps), location and morphology of each polyp will be recorded by an independent observer. The withdrawal time (minus the polypectomy site) will be measured by a stopwatch and with a minimum of 6 minutes. The bowel preparation quality will be graded according to the Boston Bowel Preparation Scale

Official Title
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Endocuff With or Without Artificial Intelligence-assisted Colonoscopy in Detection of Colorectal Adenoma: a Randomized Colonoscopy Trial

Conditions
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Colonic Adenoma, Colonic Polyp, Colonic Cancer

Intervention / Treatment
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* Device: Endocuff with AI
* Device: AI alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult patients, aged 40 or above, undergoing outpatient colonoscopy in the Queen Mary Hospital, Tung Wah Hospital and Tuen Mun Hospital in Hong Kong will be recruited. Exclusion Criteria: Patients will be excluded if they have history of inflammatory bowel disease, colorectal cancer, previous bowel resection, Peutz-Jeghers syndrome, familial adenomatous polyposis or other polyposis syndromes, bleeding tendency or severe comorbid illnesses for which polypectomy is considered unsafe. Moreover, after randomization, if the cecum could not be intubated for various reasons or Boston Bowel Preparation Scale (BBPS) score is <2, these patients will be excluded

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endocuff- AI assisted colonoscopy<br>Endocuff (Olympus, Hong Kong) and AI assisted colonoscopy will be used | Device: Endocuff with AI<br>* Use of endocuff with computer assisted polyp detection<br>|
| Active Comparator: AI-assisted colonoscopy<br>AI assisted colonoscopy will be used | Device: AI alone<br>* Use of computer assisted polyp detection<br>|
| No Intervention: Conventional colonoscopy<br>Conventional colonoscopy will be used without AI or Endocuff. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate | The proportion of patients with at least one adenomas | One month after colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyp detection rate | the proportion of patients with at least one polyp | One month after colonoscopy | 
| Sessile serrated adenomas detection rate | The proportion of patients with at least one sessile serrated adenomas | One month after colonoscopy | 
| Sessile serrated polyps detection rate | The proportion of patients with at least one sessile serrated polyps | One month after colonoscopy | 
| Advanced adenoma detection rates | The proportion of patients with at least one advanced adenomas | One month after colonoscopy | 
| Mean number of polyp per patient | The mean number of polyp per patient | One month after colonoscopy | 
| Mean number of adenoma per patient | The mean number of adenoma per patient | One month after colonoscopy | 
| Total number of polyp or adenoma per patient. | The total number of polyp or adenoma per patient. | One month after colonoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Artificial intelligence, Colonoscopy, Endocuff, Detection, Computer-aided