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

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04901130
• Other study ID #: 2021SDU-QILU-066
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 27, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: May 2021
• Source: Shandong University
• Contact: Zhen Li, PhD
• Phone: 18560086106
• Email: lizhenh[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1254
• Est. completion date: January 31, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Colonoscopy

Intervention

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.

Locations

Country	Name	City	State
China	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	The People's Hospital of Zhaoyuan City	Yantai	Shandong
China	Zibo Municipal Hospital	Zibo	Shandong

Sponsors (6)

Lead Sponsor	Collaborator
Shandong University	Binzhou Medical University, Central Hospital of Shengli Oilfield, Linyi People's Hospital, The People's Hospital of Zhaoyuan City, Zibo municipal hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 months
Secondary	Colorectal polyp detection rate (PDR)	The polyp detection rate (PDR) is the proportion of patients having one or more polyps detected by colonoscopy.	10 months
Secondary	The mean number of adenomas detected per colonoscopy (APC)	The mean number of adenomas detected per colonoscopy in AQCS and control groups	10 months
Secondary	The mean number of polyps detected per colonoscopy (PPC)	The mean number of polyps detected per colonoscopy in AQCS and control groups	10months
Secondary	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.	During procedure