Adenoma Detection Rate Using AI System in China

Changhai Hospital743 enrolled

Overview

The primary aim of this study is \- to explore the usefulness of Artificial Intelligence system in colonoscopy on adenoma detection rate (ADR). Other aims include to explore the data below when Artificial Intelligence is used. Mean adenomas detected per procedure, MAP Proximal Adenoma detection rate, pADR Polyp detection rate, PDR Proximal polyp detection rate, pPDR Mean polyps detected per procedure, MPP Withdrawal time, WT Cecal intubation rate, CIR Cecal intubation time, CIT

Colorectal cancer is common in China. Most colorectal cancers happen when an adenoma becomes cancerous. Doctors use colonoscopy to look inside the colon and rectum and find adenomas and remove them. Removing adenomas is known to reduce the chances of a person developing colorectal cancers. The ability of colonoscopists finding adenomas varies, and there is a lot of researches into how to improve "adenoma detection rates". A new AI system, called the CSK endoscopic diagnosis and treatment system has been designed to improve the rate of polyp detection at colonoscopy. Previous tests have shown that there is a significant improvement in detection of adenomas when the system is used. This study will randomize patients coming for colonoscopy to have their procedure performed as usual or as an AI-assisted colonoscopy. The investigators will record polyp and adenoma detection rates, duration of procedure, participant comfort levels, and complications. All patients referred for colonoscopy will be invited in 4 centers, recruiting a total of 800 participants.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

743

Conditions

Colorectal Neoplasms Colonic Polyp Adenoma

Interventions

CSK AI systemDEVICE

CSK system is equipped with the endoscopic mainframe and alarms the examiners when suspect lesions appear.

Standard ColonoscopyDEVICE

This is the routine examination in nowadays clinical practice. Both the equipment and the procedure are as usual as clinical routine.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * All patients referred for screening, surveillance, or diagnostic colonoscopy * All patients must be able to give informed consent Exclusion Criteria: * Patients with any absolute contraindications to colonoscopy * Patients with established or suspicion of large bowel obstruction or pseudo-obstruction * Patients with known colon cancer or polyposis syndromes * Patients with known colonic strictures * Patients with known severe diverticular segments (that is likely to impede colonoscope passage) * Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis) * Patients lacking capacity to give informed consent * Pregnancy * Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure. * Patients who are attending for a therapeutic procedure or assessment of a known lesion

Locations (4)

Sixth affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Tianjin Nankai Hospital

Tianjin, Tianjin Municipality, China

Tianjin People's Hospital

Tianjin, Tianjin Municipality, China

Outcomes

Primary Outcomes

Adenoma detection rate, ADR

ADR refer to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma.

Time frame: At the end of the procedure, up to 1 hour.

Secondary Outcomes

Polyp detection rate, PDR

PDR refer to the rate of polyp detection, calculated as the proportion of subjects with at least one polyp.

Time frame: At the end of the procedure, up to 1 hour.

Data from ClinicalTrials.gov

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