Effective Withdrawal Time and Adenoma Detection Rate

• Sponsor: The University of Hong Kong (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06063720
• Collaborator: (none)
• Enrollment: 198
• Anticipated Duration (Months): 3.8

Study Details

Study Description

Brief Summary

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 and the result of EWT will be blinded to the endoscopists

Condition or Disease	Intervention/Treatment	Phase
Colonic Polyp; Colon Adenoma; Artificial Intelligence	Device: Endoscreen 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 After cecal intubation is performed, the colonoscopy is slowly withdrawn.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 Design

• Study Type: Observational
• Anticipated Enrollment: 198 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective Evaluation of the Correlation Between Artificial Intelligence-derived Effective Withdrawal Time and Adenoma Detection Rate
• Anticipated Study Start Date: Oct 7, 2023
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Jan 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
AI group AI monitoring of effective withdrawal time	Device: Endoscreen QC; Artificial intelligence monitoring of effective withdrawal time

Outcome Measures

Primary Outcome Measures

1. Adenoma detection rates of the endoscopists [Historical record of the endoscopists up to 7 years]

   Adenoma detection rates of the endoscopists

Secondary Outcome Measures

1. Adenoma detection rate [During that colonoscopy]

   Adenoma detection rates of the colonoscopy

2. Polyp detection rate [During that colonoscopy]

   Polyp detection rates of the colonoscopy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• The University of Hong Kong

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Lui Ka-Luen, Clinical Associate Professor, The University of Hong Kong
• ClinicalTrials.gov Identifier: NCT06063720
• Other Study ID Numbers: AIeffectiveV3
• First Posted: Oct 2, 2023
• Last Update Posted: Oct 2, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr. Lui Ka-Luen, Clinical Associate Professor, The University of Hong Kong: Colonic Polyp; Artificial intelligence; Withdrawal time
• Additional relevant MeSH terms: Adenoma; Colonic Polyps

Study Results

No Results Posted as of Oct 2, 2023