Clinical trial NCT04227795: AI-assisted Detection of Missed Colonic Polyps
Official title: Artificial Intelligence-Assisted Real-time Detection of Missed Lesions During Colonoscopy: A Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Adenoma
Colonic Polyp
Colon Cancer
Keywords: Artificial intelligence
Colonoscopy
Deep learning
Detection
Computer-aided
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2020-01-14
Enrollment: 52
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A prospective validation of real time deep learning artificial intelligence model for detection of missed colonic polyps

Detailed description: Consecutive adult patients, age 40 or above, who were scheduled to have outpatient colonoscopy in the Queen Mary Hospital were invited to participate. Patients were excluded if they were unable to provide informed consent, considered to be unsafe for taking biopsy or polypectomy including patients with bleeding tendency and those with severe comorbid illnesses. Also, patients with history of inflammatory bowel disease, familial adenomatous polyposis, Peutz-Jeghers syndrome or other polyposis syndromes were excluded.

The primary endoscopist conducted the colonoscopic examination in the usual manner. All colonoscopy procedures were performed with high-definition colonoscopes (EVIS-EXERA 290 video system, Olympus Optical, Tokyo, Japan). The colonoscopy was first advanced to the cecum in all patients as confirmed by identification of the appendiceal orifice and ileocecal valve or by intubation of the ileum. After cecal intubation, the colonoscopy was slowly withdrawn to the rectum by the primary endoscopist. The AI real time detection was then activated with the output displayed in a different monitor and was only viewed by an independent investigator, who was an experienced endoscopist. The primary endoscopist was blinded to the AI real time detection result al.

The colon was divided into three segments during the examination: right side, transverse and left side colon, using hepatic flexure and splenic flexure as dividing landmark. All polyps were marked for size (measured with biopsy forceps), location and morphology according to the Paris classification, and then removed or biopsied for histological examination. After examination of each segment, segmental unblinding of the AI results were provided by the independent viewer. If additional polyps were detected by AI but not by the endoscopist, that segment were reexamined to look for the missed polyp. If no additional polyp was detected by the AI, the next colonic segment was examined. Missed lesions were defined as lesions identified by AI and then confirmed on reexamination by the endoscopist.

The first withdrawal time (minus the polypectomy site) was measured. The Boston Bowel Preparation Scale score (BPPS) was used for evaluation of bowel cleanliness.

Eligibility criteria: Inclusion Criteria:

* consecutive adult patients, age 40 or above, who were scheduled to have outpatient colonoscopy in the Queen Mary Hospital were invited to participate

Exclusion Criteria:

* Patients were excluded if they were unable to provide informed consent, considered to be unsafe for taking biopsy or polypectomy including patients with bleeding tendency and those with severe comorbid illnesses.
* Also, patients with history of inflammatory bowel disease, familial adenomatous polyposis, Peutz-Jeghers syndrome or other polyposis syndromes were excluded.

Primary outcomes:
measure: Adenoma miss rate
timeFrame: During the colonoscopy procedure
Secondary outcomes:
measure: Total number of adenoma missed
timeFrame: During the colonoscopy procedure
measure: Colonic polyp miss rate
timeFrame: During the colonoscopy procedure
measure: Total number of missed polyps
timeFrame: During the colonoscopy procedure
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: Queen Mary Hospital, the University of Hong Kong
name: Ka Luen, Thomas Lui
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lui TKL, Hui CKY, Tsui VWM, Cheung KS, Ko MKL, Foo DCC, Mak LY, Yeung CK, Lui TH, Wong SY, Leung WK. New insights on missed colonic lesions during colonoscopy through artificial intelligence-assisted real-time detection (with video). Gastrointest Endosc. 2021 Jan;93(1):193-200.e1. doi: 10.1016/j.gie.2020.04.066. Epub 2020 May 4.