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

Impact of Real-time Automatic Quality Control System on Colorectal Adenoma Detection: a Multicenter Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04901130
Enrollment
1254
Registered
2021-05-25
Start date
2021-05-27
Completion date
2022-01-31
Last updated
2021-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopy

Keywords

Artificial Intelligence, Colonoscopy, Quality Control

Brief summary

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

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.

Interventions

DEVICEComputer-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.

Sponsors

Binzhou Medical University
CollaboratorOTHER
Shengli Oilfield Hospital
CollaboratorOTHER
Linyi People's Hospital
CollaboratorOTHER
Zibo Municipal Hospital
CollaboratorOTHER
The People's Hospital of Zhaoyuan City
CollaboratorUNKNOWN
Shandong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Colorectal adenoma detection rate (ADR)10 monthsThe primary endpoint is the adenoma detection rate (ADR), which is the proportion of patients having one or more adenomas detected by colonoscopy.

Secondary

MeasureTime frameDescription
Colorectal polyp detection rate (PDR)10 monthsThe polyp detection rate (PDR) is the proportion of patients having one or more polyps detected by colonoscopy.
The mean number of adenomas detected per colonoscopy (APC)10 monthsThe mean number of adenomas detected per colonoscopy in AQCS and control groups
The mean number of polyps detected per colonoscopy (PPC)10monthsThe mean number of polyps detected per colonoscopy in AQCS and control groups
Withdrawl timeDuring procedureWithdrawl time is defined as the time taken to remove the colonoscope from the cecal pole minus the time of therapeutic interventions or biopsy, until the complete withdrawal of the colonoscope.

Countries

China

Contacts

Primary ContactZhen Li, PhD
lizhenh@hotmail.com18560086106
Backup ContactJing Liu, MD
liujingqdpd@163.com18366118559

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026