Effect of Real-time Computer-aided System (ENDO-AID) on Adenoma Detection in Endoscopist-in-training (ENDOAIDTRAIN)
Primary Purpose
Screening Colonoscopy
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
ENDO-AID CADe
Sponsored by
About this trial
This is an interventional treatment trial for Screening Colonoscopy
Eligibility Criteria
Inclusion Criteria:
- Aged 18 years old or above;
- They require elective colonoscopy for colorectal cancer screening, polyp surveillance, or investigation of symptoms such as anemia or gastrointestinal bleeding;
- Written informed consent obtained.
Exclusion Criteria:
- Contraindication to colonoscopy (e.g. intestinal obstruction or perforation)
- Contraindication or conditions precluding polyp resection (e.g. active gastrointestinal bleeding, significant bleeding tendency, uninterrupted anticoagulation or dual antiplatelets)
- Scheduled staged procedure for polypectomy or biopsy
- Previous colonic resection
- Personal history of colorectal cancer
- Personal history of polyposis syndrome
- Personal history of inflammatory bowel disease
- Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above)
- Pregnancy
- Unable to obtain informed consent
Sites / Locations
- Prince of Wales Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention arm
Control arm
Arm Description
CADe system will be used during withdrawal phase of colonoscopy.
Colonoscopy will be performed according to hospital protocol.
Outcomes
Primary Outcome Measures
ADR
adenoma detection rate
Secondary Outcome Measures
ADR for adenomas of different sizes
<5mm, 5-10mm, >10mm
ADR for adenomas of different colonic segments
caecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid colon, rectum
Mean number of adenomas per colonoscopy
Mean number of adenomas per colonoscopy
Advanced adenoma detection rate
Advanced adenoma detection rate
Sessile serrate lesion (SSL) detection rate
Sessile serrate lesion (SSL) detection rate
Polyp detection rate
Polyp detection rate
Non-neoplastic resection rate
defined as absence of adenoma or SSL within resected specimen
Missed polyp rate
defined as a polyp which the junior endoscopist fails to recognize and withdraws the endoscope to next colonic segment, but detected by the supervisor
False positive rate
defined as computer artifacts due to colonic mucosal wall or bowel content lasting for >2 seconds
Cecal intubation time
Cecal intubation time
Withdrawal time
excluding interventions
Total procedural time
Total procedural time
Percentage of change in ADR in relation to the personal experience in colonoscopy
Percentage of change in ADR in relation to the personal experience in colonoscopy based on number of procedures performed <200 vs 200-500
Full Information
NCT ID
NCT04838951
First Posted
March 23, 2021
Last Updated
February 6, 2023
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04838951
Brief Title
Effect of Real-time Computer-aided System (ENDO-AID) on Adenoma Detection in Endoscopist-in-training
Acronym
ENDOAIDTRAIN
Official Title
Effect of Real-time Computer-aided System (ENDO-AID) on Adenoma Detection in Endoscopist-in-training: a Single-blind Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 19, 2021 (Actual)
Primary Completion Date
July 22, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese 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
Yes
5. Study Description
Brief Summary
The investigator's hypothesis is that a CADe system (ENDO-AID) would improve the adenoma detection rate in junior endoscopists.
Detailed Description
Colorectal cancer (CRC) is the most common and second most lethal cancer in Hong Kong with more than 5,600 new cases and 2,300 deaths annually. Colonoscopy with polypectomy has shown to reduce CRC-related mortality by 53%. However, high polyp miss rates were reported to be up to 26% for adenomas and 9% for advanced adenomas in standard colonoscopies. Risk factors included proximal location, serrate or flat lesions, poor bowel preparation and short withdrawal time (<6 minutes). Insufficient trainee experience was also associated with a higher adenoma miss rate. A significant proportion of interval CRC was attributed to the missed lesions during index colonoscopy leading to adverse patient outcomes.
As a result, various techniques were developed to improve adenoma detection rate (ADR) during colonoscopies. Techniques including water exchange method, second examination of the right colon (retroflexion or second forward view)and cap/cuff-assisted colonoscopies were proven to increase ADR effectively. However, these techniques were operator-dependent requiring certain level of expertise.
Recently, artificial intelligence and computer-aided polyp detection (CADe) systems have developed rapidly around the globe. These systems can provide real-time CADe by flagging the suspected lesions to endoscopists, with the adoption of deep learning or convoluted neural networks. A number of prospective randomized clinical trials reported a significant increase in ADR in CADe group. The number of adenoma detected per colonoscopy was consistently higher among different polyp sizes, location and morphology. The ADR increment was particularly higher for diminutive adenomas smaller than 5mm.
Nevertheless, most of the aforementioned studies only involved senior endoscopists for the procedures. Theoretically, the senior endoscopists were more skillful to expose colonic mucosa and more experienced to distinguish the false positive computer signals, leading to an enhanced performance of CADe in real-time colonoscopies. The effect of CADe on inexperienced junior endoscopists performing colonoscopies remains largely unknown.
In this single-blind randomized study, the investigators aim to evaluate the effect of a new CADe system (ENDO-AID) on adenoma detection and quality improvement in junior endoscopists.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Screening Colonoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Endoscopist wil not be blinded to treatment. Treatment arm allocation will be concealed to patients, data collector and data analysts.
Allocation
Randomized
Enrollment
856 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
CADe system will be used during withdrawal phase of colonoscopy.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Colonoscopy will be performed according to hospital protocol.
Intervention Type
Device
Intervention Name(s)
ENDO-AID CADe
Intervention Description
ENDO-AID CADe will be used during the withdrawal process of the colonoscopy.
Primary Outcome Measure Information:
Title
ADR
Description
adenoma detection rate
Time Frame
During the colonoscopy
Secondary Outcome Measure Information:
Title
ADR for adenomas of different sizes
Description
<5mm, 5-10mm, >10mm
Time Frame
During the colonoscopy
Title
ADR for adenomas of different colonic segments
Description
caecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid colon, rectum
Time Frame
During the colonoscopy
Title
Mean number of adenomas per colonoscopy
Description
Mean number of adenomas per colonoscopy
Time Frame
During the colonoscopy
Title
Advanced adenoma detection rate
Description
Advanced adenoma detection rate
Time Frame
During the colonoscopy
Title
Sessile serrate lesion (SSL) detection rate
Description
Sessile serrate lesion (SSL) detection rate
Time Frame
During the colonoscopy
Title
Polyp detection rate
Description
Polyp detection rate
Time Frame
During the colonoscopy
Title
Non-neoplastic resection rate
Description
defined as absence of adenoma or SSL within resected specimen
Time Frame
During the colonoscopy
Title
Missed polyp rate
Description
defined as a polyp which the junior endoscopist fails to recognize and withdraws the endoscope to next colonic segment, but detected by the supervisor
Time Frame
During the colonoscopy
Title
False positive rate
Description
defined as computer artifacts due to colonic mucosal wall or bowel content lasting for >2 seconds
Time Frame
During the colonoscopy
Title
Cecal intubation time
Description
Cecal intubation time
Time Frame
During the colonoscopy
Title
Withdrawal time
Description
excluding interventions
Time Frame
During the colonoscopy
Title
Total procedural time
Description
Total procedural time
Time Frame
During the colonoscopy
Title
Percentage of change in ADR in relation to the personal experience in colonoscopy
Description
Percentage of change in ADR in relation to the personal experience in colonoscopy based on number of procedures performed <200 vs 200-500
Time Frame
During the colonoscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18 years old or above;
They require elective colonoscopy for colorectal cancer screening, polyp surveillance, or investigation of symptoms such as anemia or gastrointestinal bleeding;
Written informed consent obtained.
Exclusion Criteria:
Contraindication to colonoscopy (e.g. intestinal obstruction or perforation)
Contraindication or conditions precluding polyp resection (e.g. active gastrointestinal bleeding, significant bleeding tendency, uninterrupted anticoagulation or dual antiplatelets)
Scheduled staged procedure for polypectomy or biopsy
Previous colonic resection
Personal history of colorectal cancer
Personal history of polyposis syndrome
Personal history of inflammatory bowel disease
Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above)
Pregnancy
Unable to obtain informed consent
Facility Information:
Facility Name
Prince of Wales Hospital
City
Shatin
State/Province
New Territories
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data to other researchers
Learn more about this trial
Effect of Real-time Computer-aided System (ENDO-AID) on Adenoma Detection in Endoscopist-in-training
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