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Completed

NCT Number: NCT04227795

AI-assisted Detection of Missed Colonic Polyps

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

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Key information

About this study

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 After cecal intubation, the colonoscopy was slowly withdrawn to the rectum by the primary endoscopist.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Artificial intelligence-Assisted real time colonoscopy

Device

The colonoscopy was performed under artificial intelligence assistance

Primary outcomes

  1. Adenoma miss rate

    Time frame: During the colonoscopy procedure

    The number of patient had at least one missed adenoma

Secondary outcomes

  1. Total number of adenoma missed

    Time frame: During the colonoscopy procedure

    The total number of missed polyps for all subjects

  2. Colonic polyp miss rate

    Time frame: During the colonoscopy procedure

    The number of patient had at least one missed adenoma

  3. Total number of missed polyps

    Time frame: During the colonoscopy procedure

    The total number of missed polyps for all subjects

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Artificial Intelligence-Assisted Real-time Detection of Missed Lesions During Colonoscopy: A Prospective Study

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 14, 2020
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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