AI-assisted Detection of Missed Colonic Polyps
Primary Purpose
Colon Adenoma, Colonic Polyp, Colon Cancer
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Artificial intelligence-Assisted real time colonoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Colon Adenoma focused on measuring Artificial intelligence, Colonoscopy, Deep learning, Detection, Computer-aided
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.
Sites / Locations
- Queen Mary Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Artificial intelligence-Assisted real time colonoscopy
Arm Description
AI assisted real-time detection of colonic lesions
Outcomes
Primary Outcome Measures
Adenoma miss rate
The number of patient had at least one missed adenoma
Secondary Outcome Measures
Total number of adenoma missed
The total number of missed polyps for all subjects
Colonic polyp miss rate
The number of patient had at least one missed adenoma
Total number of missed polyps
The total number of missed polyps for all subjects
Full Information
NCT ID
NCT04227795
First Posted
January 10, 2020
Last Updated
March 2, 2020
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04227795
Brief Title
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
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Adenoma, Colonic Polyp, Colon Cancer
Keywords
Artificial intelligence, Colonoscopy, Deep learning, Detection, Computer-aided
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Artificial intelligence-Assisted real time colonoscopy
Arm Type
Experimental
Arm Description
AI assisted real-time detection of colonic lesions
Intervention Type
Device
Intervention Name(s)
Artificial intelligence-Assisted real time colonoscopy
Intervention Description
The colonoscopy was performed under artificial intelligence assistance
Primary Outcome Measure Information:
Title
Adenoma miss rate
Description
The number of patient had at least one missed adenoma
Time Frame
During the colonoscopy procedure
Secondary Outcome Measure Information:
Title
Total number of adenoma missed
Description
The total number of missed polyps for all subjects
Time Frame
During the colonoscopy procedure
Title
Colonic polyp miss rate
Description
The number of patient had at least one missed adenoma
Time Frame
During the colonoscopy procedure
Title
Total number of missed polyps
Description
The total number of missed polyps for all subjects
Time Frame
During the colonoscopy procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ka Luen, Thomas Lui
Organizational Affiliation
Queen Mary Hospital, the University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32376335
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.
Results Reference
derived
Learn more about this trial
AI-assisted Detection of Missed Colonic Polyps
We'll reach out to this number within 24 hrs