Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Adenoma

Colonic Polyps

Polyps

Colonic Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Polyps

Pathological Conditions, Anatomical

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Endocuff (Olympus, Hong Kong) and AI assisted colonoscopy will be used

Conventional colonoscopy will be used without AI or Endocuff.

Use of endocuff with computer assisted polyp detection

Endocuff with AI

AI alone

Ka Luen, Thomas Lui, MBBS

Thomas K Lui, MBBS

Wai Keung Leung, MD

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.

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 After cecal intubation is performed, the colonoscopy is first withdrawn according to the group assigned.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

Endocuff With or Without AI-assisted Colonoscopy

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

The proportion of patients with at least one adenomas

the proportion of patients with at least one polyp

The proportion of patients with at least one sessile serrated adenomas

The proportion of patients with at least one sessile serrated polyps

The proportion of patients with at least one advanced adenomas

The total number of polyp or adenoma per patient.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Endocuff With or Without AI-assisted Colonoscopy	NCT05133544	Colonic Adenoma Colonic Polyp Colonic Cancer	Endocuff with A... AI alone	40 Years -	The University of Hong Kong
Endocuff With or Without AI-assisted Colonoscopy	NCT05133544	Colonic Adenoma Colonic Polyp Colonic Cancer	Endocuff with A... AI alone	40 Years -	The University of Hong Kong

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