Clinical trial NCT03761771: Artificial Intelligence Identifying Polyps in Real-world Colonoscopy
Official title: Validating the Performance of Artificial Intelligence in Identifying Polyps in Real-world Colonoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sensitivity of the ADS in Identifying Polyps in Real-world Colonoscopy
Mean Number of Polyps Per Colonoscopy for Colonoscopists and Colonoscopists + ADS
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2018-12-03
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive outpatient who recieved colonoscopy

Brief summary: Recently, artificial intelligence (AI) assisted image recognition has made remarkable breakthroughs in various medical fields with the developing of deep learning and conventional neural networks (CNNs). However, all current AI assisted-diagnosis systems (ADSs) were established and validated on endoscopic images or selected videos, while its actual assisted-diagnosis performance in real-world colonoscopy is up to now unknown. Therefore, we validated the performance of an ADS in real-world colonoscopy, which is based on deep learning algorithm and CNNs, trained and tested in multicenter datasets of 20 endoscopy centers.

Detailed description: The ADS were established in changhai digestive endoscopy center to assess its efficacy in clinical practice. The ADS automatically initiated once the ileocecal valve was pictured by the colonoscopist or the colonoscopist recorded any image of colon during the insertion. When colonoscopists withdrew the colonoscopies and inspect the colons, the video streaming of colonoscopies was real-time switched to the ADS, which made it feasible to identify and classify lesions in real time. Colonoscopists were invited to respond if they doubted potential polyps in the screen, and the ADS also made a voice when identifying potential polyps, followed by repeatedly inspecting to confirm the existence of lesions. The voice of ADS could be real-time heard by colonoscopists, while the screen of ADS was placed right behind colonoscopists, where polyps identified by ADS could be seen after the colonoscopists' turning but not simultaneously. The lesion detection by ADS or colonoscopists were determined as follow: A. polyps only identified by ADS, which was considered to be missed by colonoscopists: polyps were reported by the ADS and the colonoscopists did not know the location of polyps without reminder of the ADS until the polyps disappeared from the view; B. polyps first identified by ADS: polyps were first reported by the ADS and the colonoscopists also later knew the location of polyps by themselves; C. polyps simultaneously identified by the ADS and colonoscopists: the time of reporting polyps was closely synchronal (within 1 second); D. polyps first reported by colonoscopists: polyps were first reported by the colonoscopists and the ADS also later identified the location of polyps before the colonoscopists unfolded and pictured the polyps; E. polyps only reported by colonoscopists, which was considered to be missed by the ADS: polyps were reported by the colonoscopists and the ADS did not identify the location of polyps until colonoscopists unfolded and pictured the polyps. Besides, the false-positives of real-world ADS were also reported with potential causes analyzed by colonoscopists.

Eligibility criteria: Inclusion Criteria:

* patients receiving screening colonoscopy
* patients receiving surveillance colonoscopy
* patients receiving diagnostic colonoscopy

Exclusion Criteria:

* patients with declined consent
* patients with poor bowel preparation
* patients with failed cecal intubation
* patients with colonic resection
* patients with inflammatory bowel diseases
* patients with polyposis

Primary outcomes:
measure: sensitivity of the ADS in identifying polyps
timeFrame: 1 hour
Secondary outcomes:
measure: false positves of the ADS per colonoscopy withdrawal
timeFrame: 1 hour
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital, Second Military Medical University
city: Shanghai
country: China
facility: Changhai Hospital
Study officials:
References:
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