Impact of Real-time Automatic Quality Control System on Colorectal Adenoma Detection

NCT ID: NCT04901130

Last Updated: 2021-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1254 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-27

Study Completion Date

2022-01-31

Brief Summary

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The purpose of this study was to assess the performance of automatic quality-control system (AQCS) in real-time quality control of colonoscopy.

Detailed Description

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We carried a multicenter randomised controlled trial to assess the performance of this system in quality control of real-time colonoscopy, including the adenoma detection rate (ADR), withdraw time, adequate bowel preparation rate and other indicators.

Conditions

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Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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AQCS-aided group

Patients in AQCS-aided group will go through colonoscopy examination with the assitance of AQCS.

Group Type EXPERIMENTAL

Computer-aided Real-time Automatic Quality Control System (AQCS)

Intervention Type DEVICE

Automatic quality-control system(AQCS), developed based on deep convolutional neural network (DCNN) models, could improve the colonoscopists' performance during withdrawal phase and significantly increase polyp and adenoma detection.

Control group

Patients in control group will go through conventional standard colonoscopy examination without the assistance of the AQCS.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Computer-aided Real-time Automatic Quality Control System (AQCS)

Automatic quality-control system(AQCS), developed based on deep convolutional neural network (DCNN) models, could improve the colonoscopists' performance during withdrawal phase and significantly increase polyp and adenoma detection.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Consecutive patients (aged 18-80 years) scheduled for colonoscopy examination.

Exclusion Criteria

* Patients with a history of inflammatory bowel disease, advanced colorectal cancer, polyposis syndromes or known colorectal polyps without complete removal previously.
* Patients with a history of colorectal surgery.
* Patients with a contraindication for biopsy.
* Patients with prior failed colonoscopy.
* Patients with known stenosis or obstruction.
* Patients in pregnancy or lactation phase.
* Patients refused to participate in the trial.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Binzhou Medical University

OTHER

Sponsor Role collaborator

Shengli Oilfield Hospital

OTHER

Sponsor Role collaborator

Linyi People's Hospital

OTHER

Sponsor Role collaborator

Zibo Municipal Hospital

OTHER

Sponsor Role collaborator

The People's Hospital of Zhaoyuan City

UNKNOWN

Sponsor Role collaborator

Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Vice president of Qilu Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanqing Li, PhD

Role: STUDY_CHAIR

Qilu Hospital of Shandong University

Xiuli Zuo, PhD

Role: STUDY_CHAIR

Qilu Hospital of Shandong University

Locations

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Binzhou Medical University Hospital

Binzhou, Shandong, China

Site Status

Linyi People's Hospital

Dezhou, Shandong, China

Site Status

Central Hospital of Shengli Oilfield

Dongying, Shandong, China

Site Status

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status

The People's Hospital of Zhaoyuan City

Yantai, Shandong, China

Site Status

Zibo Municipal Hospital

Zibo, Shandong, China

Site Status

Countries

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China

Central Contacts

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Zhen Li, PhD

Role: CONTACT

18560086106

Jing Liu, MD

Role: CONTACT

18366118559

Facility Contacts

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Qiong Niu

Role: primary

Xiaodong Zhang

Role: primary

Zhenqin Cui

Role: primary

Yanqing Li

Role: primary

Xiuli Zuo

Role: backup

Li Xing

Role: primary

Weidong Zhao

Role: primary

References

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Liu J, Zhou R, Liu C, Liu H, Cui Z, Guo Z, Zhao W, Zhong X, Zhang X, Li J, Wang S, Xing L, Zhao Y, Ma R, Ni J, Li Z, Li Y, Zuo X. Automatic Quality Control System and Adenoma Detection Rates During Routine Colonoscopy: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2457241. doi: 10.1001/jamanetworkopen.2024.57241.

Reference Type DERIVED
PMID: 39883463 (View on PubMed)

Other Identifiers

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2021SDU-QILU-066

Identifier Type: -

Identifier Source: org_study_id

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