Clinical trial NCT04126265: Artificial Intelligence-assisted Colonoscopy for Detection of Colon Polyps
Official title: Artificial Intelligence-assisted Colonoscopy for Detection of Colon Polyps: a Prospective Randomized Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Artificial Intelligence
Colonoscopy
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: All subjects shall sign informed consent before screening, and subjects shall be included according to inclusion and exclusion criteria.

A total of four endoscopists were included in the study, two in each group of senior endoscopists and two in each group of junior endoscopists.

Patients were randomly enrolled into the senior endoscopy group and the junior endoscopy group, and received artificial intelligence assisted colonoscopy and conventional colonoscopy successively. The two colonoscopy methods were performed back to back by different endoscopy physicians with the same seniority.

All patients were examined and treated according to routine medical procedures. The routine colonoscopy group and the artificial-intelligence-assisted colonoscopy group made detailed records of the patients' withdrawal time, entry time, number of polyps detected, polyp Paris classification, polyp size, polyp shape, polyp location and intestinal preparation during the colonoscopy process

Detailed description: This is a prospective randomized clinical study.This study was conducted in the Endoscopy Center of the Nanfang Hospital, China. Routine bowel preparation consisted of 4 L of polyethylene glycol, given in split doses. Colonoscopies were performed with high definition colonoscopes and high-definition monitors.

All subjects shall sign informed consent before screening, and subjects shall be included according to inclusion and exclusion criteria.

A total of four endoscopists were included in the study, two in each group of senior endoscopists (\>1000 colonoscopies) and two in each group of junior endoscopists ( \<1000 colonoscopies).

Patients were randomly enrolled into the senior endoscopy group and the junior endoscopy group, and received artificial intelligence assisted colonoscopy and conventional colonoscopy successively. The two colonoscopy methods were performed by different endoscopy physicians back to back with the same seniority.

All patients were examined and treated according to routine medical procedures (outpatient patients and inpatients who did not sign the consent form for polypectomy were not resected for the lesions detected during the examination, while inpatients who signed the consent form for polypectomy were left in the original position after the first colonoscopy and removed at the end of the second examination).

The routine colonoscopy group and the artificial-intelligence-assisted colonoscopy group made detailed records of the patients' withdrawal time, entry time, number of polyps detected, polyp Paris classification, polyp size, polyp shape, polyp location and intestinal preparation during the colonoscopy process.

Eligibility criteria: Inclusion Criteria:

Chinese population aged 18-80 years old; Patients voluntarily signed informed consent form; In accordance with the indications of colonoscopy.

Exclusion Criteria:

(IBD) history of inflammatory bowel disease; History of colorectal surgery; Previous failed colonoscopy; Polyposis syndrome; Highly suspected colorectal cancer (CRC)

Primary outcomes:
measure: Detection rate of small polyps (diameter < 6mm)
timeFrame: 6 months
Secondary outcomes:
measure: Number of polyps detected
timeFrame: 6 months
measure: Polyp size
timeFrame: 6 months
measure: Polyp morphology
timeFrame: 6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
Study officials:
affiliation: Chief physician
name: side liu, doctor degree
role: PRINCIPAL_INVESTIGATOR
References:
citation: Luo Y, Zhang Y, Liu M, Lai Y, Liu P, Wang Z, Xing T, Huang Y, Li Y, Li A, Wang Y, Luo X, Liu S, Han Z. Artificial Intelligence-Assisted Colonoscopy for Detection of Colon Polyps: a Prospective, Randomized Cohort Study. J Gastrointest Surg. 2021 Aug;25(8):2011-2018. doi: 10.1007/s11605-020-04802-4. Epub 2020 Sep 23.