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

May 24, 2021 updated by: Yanqing Li, Shandong University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1254

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shandong
      • Binzhou, Shandong, China
        • Binzhou Medical University Hospital
        • Contact:
          • Qiong Niu
      • Dezhou, Shandong, China
        • Linyi People's Hospital
        • Contact:
          • Xiaodong Zhang
      • Dongying, Shandong, China
        • Central Hospital of Shengli Oilfield
        • Contact:
          • Zhenqin Cui
      • Jinan, Shandong, China, 250012
        • Qilu Hospital of Shandong University
        • Contact:
          • Yanqing Li
        • Contact:
          • Xiuli Zuo
      • Yantai, Shandong, China
        • The People's Hospital of Zhaoyuan City
      • Zibo, Shandong, China
        • Zibo Municipal Hospital
        • Contact:
          • Weidong Zhao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AQCS-aided group
Patients in AQCS-aided group will go through colonoscopy examination with the assitance of AQCS.
Device: 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.
No Intervention: Control group
Patients in control group will go through conventional standard colonoscopy examination without the assistance of the AQCS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Colorectal adenoma detection rate (ADR)
Time Frame: 10 months
The primary endpoint is the adenoma detection rate (ADR), which is the proportion of patients having one or more adenomas detected by colonoscopy.
10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Colorectal polyp detection rate (PDR)
Time Frame: 10 months
The polyp detection rate (PDR) is the proportion of patients having one or more polyps detected by colonoscopy.
10 months
The mean number of adenomas detected per colonoscopy (APC)
Time Frame: 10 months
The mean number of adenomas detected per colonoscopy in AQCS and control groups
10 months
The mean number of polyps detected per colonoscopy (PPC)
Time Frame: 10months
The mean number of polyps detected per colonoscopy in AQCS and control groups
10months
Withdrawl time
Time Frame: During procedure
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.
During procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Collaborators

Linyi People's Hospital
Binzhou Medical University
The People's Hospital of Zhaoyuan City
Central Hospital of Shengli Oilfield
Zibo Municipal Hospital

Investigators

  • Study Chair: Yanqing Li, PhD, Qilu Hospital of Shandong University
  • Study Chair: Xiuli Zuo, PhD, Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 27, 2021

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

January 31, 2022

Study Registration Dates

First Submitted

May 24, 2021

First Submitted That Met QC Criteria

May 24, 2021

First Posted (Actual)

May 25, 2021

Study Record Updates

Last Update Posted (Actual)

May 25, 2021

Last Update Submitted That Met QC Criteria

May 24, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021SDU-QILU-066

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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