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

Shandong University1,254 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

1,254

Conditions

Colonoscopy

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (6)

Binzhou Medical University Hospital

Binzhou, Shandong, China

Linyi People's Hospital

Dezhou, Shandong, China

Central Hospital of Shengli Oilfield

Dongying, Shandong, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Outcomes

Primary Outcomes

Colorectal adenoma detection rate (ADR)

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

Time frame: 10 months

Secondary Outcomes

Colorectal polyp detection rate (PDR)

The polyp detection rate (PDR) is the proportion of patients having one or more polyps detected by colonoscopy.

Time frame: 10 months

The mean number of adenomas detected per colonoscopy (APC)

The mean number of adenomas detected per colonoscopy in AQCS and control groups

Time frame: 10 months

The mean number of polyps detected per colonoscopy (PPC)

The mean number of polyps detected per colonoscopy in AQCS and control groups

Time frame: 10months

Withdrawl time

Withdrawl 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.

Time frame: During procedure

Central Contacts

Zhen Li, PhD

CONTACT

18560086106 lizhenh@hotmail.com

Jing Liu, MD

CONTACT

18366118559 liujingqdpd@163.com

Data from ClinicalTrials.gov

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