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

Primary Purpose

Colonoscopy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Computer-aided Real-time Automatic Quality Control System (AQCS)
Sponsored by
Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Colonoscopy focused on measuring Artificial Intelligence, Colonoscopy, Quality Control

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

AQCS-aided group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Colorectal polyp detection rate (PDR)
The 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)
The mean number of adenomas detected per colonoscopy in AQCS and control groups
The mean number of polyps detected per colonoscopy (PPC)
The mean number of polyps detected per colonoscopy in AQCS and control groups
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.

Full Information

First Posted
May 24, 2021
Last Updated
May 24, 2021
Sponsor
Shandong University
Collaborators
Binzhou Medical University, Central Hospital of Shengli Oilfield, Linyi People's Hospital, Zibo municipal hospital, The People's Hospital of Zhaoyuan City
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1. Study Identification

Unique Protocol Identification Number
NCT04901130
Brief Title
Impact of Real-time Automatic Quality Control System on Colorectal Adenoma Detection
Official Title
Impact of Real-time Automatic Quality Control System on Colorectal Adenoma Detection: a Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 27, 2021 (Anticipated)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
Collaborators
Binzhou Medical University, Central Hospital of Shengli Oilfield, Linyi People's Hospital, Zibo municipal hospital, The People's Hospital of Zhaoyuan City

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonoscopy
Keywords
Artificial Intelligence, Colonoscopy, Quality Control

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1254 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AQCS-aided group
Arm Type
Experimental
Arm Description
Patients in AQCS-aided group will go through colonoscopy examination with the assitance of AQCS.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients in control group will go through conventional standard colonoscopy examination without the assistance of the AQCS.
Intervention Type
Device
Intervention Name(s)
Computer-aided Real-time Automatic Quality Control System (AQCS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Colorectal adenoma detection rate (ADR)
Description
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 Outcome Measure Information:
Title
Colorectal polyp detection rate (PDR)
Description
The polyp detection rate (PDR) is the proportion of patients having one or more polyps detected by colonoscopy.
Time Frame
10 months
Title
The mean number of adenomas detected per colonoscopy (APC)
Description
The mean number of adenomas detected per colonoscopy in AQCS and control groups
Time Frame
10 months
Title
The mean number of polyps detected per colonoscopy (PPC)
Description
The mean number of polyps detected per colonoscopy in AQCS and control groups
Time Frame
10months
Title
Withdrawl time
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhen Li, PhD
Phone
18560086106
Email
lizhenh@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Liu, MD
Phone
18366118559
Email
liujingqdpd@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanqing Li, PhD
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Xiuli Zuo, PhD
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Study Chair
Facility Information:
Facility Name
Binzhou Medical University Hospital
City
Binzhou
State/Province
Shandong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiong Niu
Facility Name
Linyi People's Hospital
City
Dezhou
State/Province
Shandong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaodong Zhang
Facility Name
Central Hospital of Shengli Oilfield
City
Dongying
State/Province
Shandong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenqin Cui
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanqing Li
First Name & Middle Initial & Last Name & Degree
Xiuli Zuo
Facility Name
The People's Hospital of Zhaoyuan City
City
Yantai
State/Province
Shandong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Xing
Facility Name
Zibo Municipal Hospital
City
Zibo
State/Province
Shandong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weidong Zhao

12. IPD Sharing Statement

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

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