Clinical trial NCT03840590: Adenoma Detection Rate Using AI System in China
Official title: Adenoma Detection Rate Using Artificial Intelligence System in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Colonic Polyp
Adenoma
Keywords: adenoma detection rate
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Sixth Affiliated Hospital, Sun Yat-sen University
name: Shanghai Zhongshan Hospital
name: Tianjin People's Hospital
name: Tianjin Nankai Hospital
First posted: 2019-02-15
Enrollment: 743
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: CSK endoscopic diagnosis and treatment system a new system of artificial intelligence. It is manufactured by Tianjin Yujin Limited in China. It is equipped with the endoscopic mainframe and has the access to the endoscopic video and image. When lesion-like objects appear in the real-time video, the system will alarm the examiners by sound.
Primary purpose: DIAGNOSTIC

Brief summary: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adenoma detection rate, ADR
timeFrame: At the end of the procedure, up to 1 hour.
Secondary outcomes:
measure: Polyp detection rate, PDR
timeFrame: At the end of the procedure, up to 1 hour.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sixth affiliated Hospital, Sun Yat-Sen University
state: Guangdong
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Nankai Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin People's Hospital
state: Tianjin
Study officials:
affiliation: Changhai Hospital
name: En-Da YU, MD
role: PRINCIPAL_INVESTIGATOR
References: