Endocuff With or Without AI-assisted Colonoscopy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colonic Polyp; Colonic Cancer; Colonic Adenoma
• Intervention / Treatment: Device: Endocuff with AI; Device: AI alone

Detailed Description

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 After cecal intubation is performed, the colonoscopy is first withdrawn according to the group assigned.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

• Study Type: Interventional
• Enrollment (Anticipated): 656
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ka Luen, Thomas Lui, MBBS; Phone Number: 22554048; Email: klluitc@yahoo.com.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Queen Mary Hospital
    • Contact: Thomas K Lui, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Study Director: Wai Keung Leung, MD, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: November 12, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Detection; Colonoscopy; Artificial intelligence; Endocuff; Computer-aided
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Colorectal Neoplasms; Polyps; Intestinal Polyps; Adenoma; Colonic Polyps; Colonic Neoplasms
• Other Study ID Numbers: UW 20-647

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No