Screening ColonoscopyENDOAIDTRAINNCT04838951
Effect of Real-time Computer-aided System (ENDO-AID) on Adenoma Detection in Endoscopist-in-training
A study testing ENDO-AID CADe in people with Screening Colonoscopy, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The investigator's hypothesis is that a CADe system (ENDO-AID) would improve the adenoma detection rate in junior endoscopists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Screening Colonoscopy
- What is being tested?
- ENDO-AID CADe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 856 participants
- Where
- 1 siteHong Kong
- Study dates
- 19 Apr 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Real-time Computer-aided System (ENDO-AID) on Adenoma Detection in Endoscopist-in-training: a Single-blind Randomized Study
The investigator's hypothesis is that a CADe system (ENDO-AID) would improve the adenoma detection rate in junior endoscopists.
Read the 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.
- Conditions
- Screening Colonoscopy
- Being tested
- ENDO-AID CADe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENDO-AID CADeDevice
ENDO-AID CADe will be used during the withdrawal process of the colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | CADe system will be used during withdrawal phase of colonoscopy. Receives: Device: ENDO-AID CADe |
| Control arm | No intervention | Colonoscopy will be performed according to hospital protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADR
adenoma detection rate
Measured: During the colonoscopy
Secondary outcomes (13)
ADR for adenomas of different sizes
<5mm, 5-10mm, >10mm
Measured: During the colonoscopy
ADR for adenomas of different colonic segments
caecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid colon, rectum
Measured: During the colonoscopy
Mean number of adenomas per colonoscopy
Mean number of adenomas per colonoscopy
Measured: During the colonoscopy
Advanced adenoma detection rate
Advanced adenoma detection rate
Measured: During the colonoscopy
Sessile serrate lesion (SSL) detection rate
Sessile serrate lesion (SSL) detection rate
Measured: During the colonoscopy
Polyp detection rate
Polyp detection rate
Measured: During the colonoscopy
Non-neoplastic resection rate
defined as absence of adenoma or SSL within resected specimen
Measured: During the colonoscopy
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
Measured: During the colonoscopy
False positive rate
defined as computer artifacts due to colonic mucosal wall or bowel content lasting for >2 seconds
Measured: During the colonoscopy
Cecal intubation time
Cecal intubation time
Measured: During the colonoscopy
Withdrawal time
excluding interventions
Measured: During the colonoscopy
Total procedural time
Total procedural time
Measured: During the colonoscopy
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
Measured: During the colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start19 Apr 2021
- Primary completion22 Jul 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Screening ColonoscopyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 856 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louis Ho Shing Lau, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838951
- Sponsor's protocol ID
- 2021.141
- Acronym
- ENDOAIDTRAIN
- Status last verified
- Feb 2023
- First submitted
- 23 Mar 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data to other researchers
Publications
Lau LHS, Ho JCL, Lai JCT, Ho AHY, Wu CWK, Lo VWH, Lai CMS, Scheppach MW, Sia F, Ho KHK, Xiao X, Yip TCF, Lam TYT, Kwok HYH, Chan HCH, Lui RN, Chan TT, Wong MTL, Ho MF, Ko RCW, Hon SF, Chu S, Futaba K, Ng SSM, Yip HC, Tang RSY, Wong VWS, Chan FKL, Chiu PWY; ENDOAID-TRAIN study group. Effect of Real-Time Computer-Aided Polyp Detection System (ENDO-AID) on Adenoma Detection in Endoscopists-in-Training: A Randomized Trial. Clin Gastroenterol Hepatol. 2024 Mar;22(3):630-641.e4. doi: 10.1016/j.cgh.2023.10.019. Epub 2023 Nov 2.
PubMed 37918685
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Real-time Computer-aided System (ENDO-AID) on Adenoma Detection in Endoscopist-in-training: a Single-blind Randomized Study
- ClinicalTrials.gov ID
- NCT04838951
- Acronym / sponsor ID
- ENDOAIDTRAIN / 2021.141
- Conditions
- Screening Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 856 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Device: ENDO-AID CADeCADe system will be used during withdrawal phase of colonoscopy. |
| Control arm | No intervention | –Colonoscopy will be performed according to hospital protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENDO-AID CADeENDO-AID CADe will be used during the withdrawal process of the colonoscopy. | Device | Intervention arm |
Primary outcome
ADR
Time frame: During the colonoscopy
adenoma detection rate
13 secondary outcomes
ADR for adenomas of different sizes
Time frame: During the colonoscopy
ADR for adenomas of different colonic segments
Time frame: During the colonoscopy
Mean number of adenomas per colonoscopy
Time frame: During the colonoscopy
Advanced adenoma detection rate
Time frame: During the colonoscopy
Sessile serrate lesion (SSL) detection rate
Time frame: During the colonoscopy
Polyp detection rate
Time frame: During the colonoscopy
Non-neoplastic resection rate
Time frame: During the colonoscopy
Missed polyp rate
Time frame: During the colonoscopy
False positive rate
Time frame: During the colonoscopy
Cecal intubation time
Time frame: During the colonoscopy
Withdrawal time
Time frame: During the colonoscopy
Total procedural time
Time frame: During the colonoscopy
Percentage of change in ADR in relation to the personal experience in colonoscopy
Time frame: During the colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 37918685Lau LHS, Ho JCL, Lai JCT, Ho AHY, Wu CWK, Lo VWH, Lai CMS, Scheppach MW, Sia F, Ho KHK, Xiao X, Yip TCF, Lam TYT, Kwok HYH, Chan HCH, Lui RN, Chan TT, Wong MTL, Ho MF, Ko RCW, Hon SF, Chu S, Futaba K, Ng SSM, Yip HC, Tang RSY, Wong VWS, Chan FKL, Chiu PWY; ENDOAID-TRAIN study group. Effect of Real-Time Computer-Aided Polyp Detection System (ENDO-AID) on Adenoma Detection in Endoscopists-in-Training: A Randomized Trial. Clin Gastroenterol Hepatol. 2024 Mar;22(3):630-641.e4. doi: 10.1016/j.cgh.2023.10.019. Epub 2023 Nov 2.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENDO-AID CADe in people with Screening Colonoscopy, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADR (time frame: During the colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04838951, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.