Real Time Effective Withdrawal Time and Adenoma Detection Rate

A Prospective Evaluation of the Correlation Between Real Time Artificial Intelligence-derived Effective Withdrawal Time and Adenoma Detection Rate

The goal of this observational study is to assess the correlation between the artificial intelligence (AI) derived effective withdrawal time (EWT) during colonoscopy and endoscopists' baseline adenoma detection rate (ADR). The association between the AI derived EWT with ADR during the prospective colonoscopy series would also be determined. The colonoscopy video of participants will be monitored by the AI

Study Overview

• Status: Recruiting
• Conditions: Artificial Intelligence; Colon Adenoma; Colon Polyp
• Intervention / Treatment: Device: Endoscreener QC

Detailed Description

This is a prospective colonoscopy trial using artificial intelligence (AI) real time effective mucosal examination monitor system (EndoScreener QC, Wision A.I. Shanghai & Chengdu). Low residue diet will be taken by all patients two days before the scheduled colonoscopy. Oral polyethylene glycol lavage solution is used for bowel preparation as in usual hospital practice. All examination will be performed with high-definition endoscopes (EVIS-EXERA 290 video system, Olympus Optical, Tokyo, Japan) under white light by experienced endoscopists. 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 After cecal intubation is performed, the colonoscopy is slowly withdrawn. 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. The AI derived (AI) real time effective mucosal examination monitor system (EndoScreen QC) will be initiated during scope withdrawal, starting from cecum to anus. The polypectomy or biopsy time will be removed as determination of standard withdrawal time. All endoscopists will be blinded to the results of AI real time monitoring of EWT. All polyp specimens removed will be clearly labelled and send for histological examination. All resected and biopsy specimens are fixed in 10% buffered formalin solution, and examined histologically by hematoxylin and eosin staining. The histopathological diagnosis is determined by experienced pathologists, who are blinded to the assigned endoscopic system, according to the World Health Organization (WHO) criteria. Advanced adenomas are defined as adenoma ≥10 mm in diameter or with villous histology in 25% or high-grade dysplasia (HGD), or carcinoma.The primary outcome of this study is to correlate the adenoma detection rates of the endoscopists with EWT.

• Study Type: Observational
• Enrollment (Estimated): 198

Contacts and Locations

• Study Contact: Name: Thomas Ka-Luen Lui; Phone Number: +85297360997; Email: tkllui@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Queen Mary Hospital, the University of Hong Kong
    • Contact: Thomas Ka Luen Lui; Phone Number: +852 97360997; Email: tkllui@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All patient will be recruited in Queen Mary Hospital, Hong Kong, China

Description

Inclusion Criteria:

• All adult patients, aged 40 or above, undergoing outpatient colonoscopy will be recruited

Exclusion Criteria:

• history of inflammatory bowel disease
• history of colorectal cancer
• previous bowel resection (apart from appendectomy)
• Peutz-Jeghers syndrome, familial adenomatous polyposis or other polyposis syndromes
• bleeding tendency or severe comorbid illnesses for which polypectomy is considered unsafe.
• Cecum could not be intubated for various reasons
• Poor bowel preparation with Boston Bowel Preparation Scale (BBPS) < 6

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AI group; AI monitoring of effective withdrawal time	Device: Endoscreener QC; Artificial intelligence monitoring of effective withdrawal time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma detection rates of the endoscopists	Adenoma detection rates of the endoscopists	Historical record of the endoscopists up to 7 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma detection rate	Adenoma detection rate	During that colonoscopy
Polyp detection rate	Polyp detection rate	During that colonoscopy

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Thomas Ka-Luen Lui, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Artificial Intelligence; Colon Polyp; Withdrawal time
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Adenoma; Colonic Polyps
• Other Study ID Numbers: AIeffectiveV4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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