Adenoma Detection Rate Using AI System in China (SinoAIADR)

Adenoma Detection Rate Using Artificial Intelligence System in China

The primary aim of this study is

- to explore the usefulness of Artificial Intelligence system in colonoscopy on adenoma detection rate (ADR). Other aims include to explore the data below when Artificial Intelligence is used.

Mean adenomas detected per procedure, MAP Proximal Adenoma detection rate, pADR Polyp detection rate, PDR Proximal polyp detection rate, pPDR Mean polyps detected per procedure, MPP Withdrawal time, WT Cecal intubation rate, CIR Cecal intubation time, CIT

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasms; Adenoma; Colonic Polyp
• Intervention / Treatment: Device: CSK AI system; Device: Standard Colonoscopy

Detailed Description

Colorectal cancer is common in China. Most colorectal cancers happen when an adenoma becomes cancerous. Doctors use colonoscopy to look inside the colon and rectum and find adenomas and remove them. Removing adenomas is known to reduce the chances of a person developing colorectal cancers. The ability of colonoscopists finding adenomas varies, and there is a lot of researches into how to improve "adenoma detection rates".

A new AI system, called the CSK endoscopic diagnosis and treatment system has been designed to improve the rate of polyp detection at colonoscopy. Previous tests have shown that there is a significant improvement in detection of adenomas when the system is used. This study will randomize patients coming for colonoscopy to have their procedure performed as usual or as an AI-assisted colonoscopy. The investigators will record polyp and adenoma detection rates, duration of procedure, participant comfort levels, and complications. All patients referred for colonoscopy will be invited in 4 centers, recruiting a total of 800 participants.

• Study Type: Interventional
• Enrollment (Actual): 743
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510655
      • Sixth Affiliated Hospital, Sun Yat-sen University
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Shanghai Zhongshan Hospital
  • Tianjin
    • Tianjin, Tianjin, China, 300121
      • Tianjin People's Hospital
    • Tianjin, Tianjin, China, 300100
      • Tianjin Nankai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients referred for screening, surveillance, or diagnostic colonoscopy
• All patients must be able to give informed consent

Exclusion Criteria:

• Patients with any absolute contraindications to colonoscopy
• Patients with established or suspicion of large bowel obstruction or pseudo-obstruction
• Patients with known colon cancer or polyposis syndromes
• Patients with known colonic strictures
• Patients with known severe diverticular segments (that is likely to impede colonoscope passage)
• Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
• Patients lacking capacity to give informed consent
• Pregnancy
• Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure.
• Patients who are attending for a therapeutic procedure or assessment of a known lesion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AI-assisted Colonoscopy; Participants in this arm undergo AI-assisted colonoscopy using CSK AI system.	Device: CSK AI system; CSK system is equipped with the endoscopic mainframe and alarms the examiners when suspect lesions appear.
Active Comparator: Standard Colonoscopy; Participants in this arm undergo standard colonoscopy.	Device: Standard Colonoscopy; This is the routine examination in nowadays clinical practice. Both the equipment and the procedure are as usual as clinical routine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma detection rate, ADR	ADR refer to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma.	At the end of the procedure, up to 1 hour.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polyp detection rate, PDR	PDR refer to the rate of polyp detection, calculated as the proportion of subjects with at least one polyp.	At the end of the procedure, up to 1 hour.

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Collaborators: Shanghai Zhongshan Hospital; Sixth Affiliated Hospital, Sun Yat-sen University; Tianjin Nankai Hospital; Tianjin People's Hospital
• Investigators: Principal Investigator: En-Da YU, MD, Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2019
• Primary Completion (Actual): December 5, 2019
• Study Completion (Actual): December 5, 2019

Study Registration Dates

• First Submitted: February 12, 2019
• First Submitted That Met QC Criteria: February 12, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): September 25, 2020
• Last Update Submitted That Met QC Criteria: September 24, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: adenoma detection rate
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Rectal Diseases; Polyps; Intestinal Polyps; Colorectal Neoplasms; Adenoma; Colonic Polyps
• Other Study ID Numbers: SINOCOLO2019B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No