AI-assisted Detection of Missed Colonic Polyps

Not Applicable

Completed

• Conditions: Colon Adenoma; Colonic Polyp; Colon Cancer
• Interventions: Device: Artificial intelligence-Assisted real time colonoscopy

• Registration Number: NCT04227795
• Lead Sponsor: The University of Hong Kong

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 After cecal intubation, the colonoscopy was slowly withdrawn to the rectum by the primary endoscopist.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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-01-10
• Study First Submitted QC: 2020-01-13
• Study First Posted: 2020-01-14
• Primary Completion: 2020-02-01
• Status Verified: 2020-03
• Study Completion: 2020-03-01
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Artificial intelligence-Assisted real time colonoscopy	Artificial intelligence-Assisted real time colonoscopy	AI assisted real-time detection of colonic lesions

Primary Outcome Measures

Name	Time	Method
Adenoma miss rate	During the colonoscopy procedure	The number of patient had at least one missed adenoma

Secondary Outcome Measures

Name	Time	Method
Total number of missed polyps	During the colonoscopy procedure	The total number of missed polyps for all subjects
Total number of adenoma missed	During the colonoscopy procedure	The total number of missed polyps for all subjects
Colonic polyp miss rate	During the colonoscopy procedure	The number of patient had at least one missed adenoma

Trial Locations

Locations (1)

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong