Colon Cancer Clinical Trial
Official title:
Artificial Intelligence-Assisted Real-time Detection of Missed Lesions During Colonoscopy: A Prospective Study
A prospective validation of real time deep learning artificial intelligence model for detection of missed colonic polyps
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 After cecal intubation, the colonoscopy was slowly withdrawn to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.
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