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Effect of Real-time Computer-aided System (ENDO-AID) on Adenoma Detection in Endoscopist-in-training

Effect of Real-time Computer-aided System (ENDO-AID) on Adenoma Detection in Endoscopist-in-training: a Single-blind Randomized Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04838951
Acronym
ENDOAIDTRAIN
Enrollment
856
Registered
2021-04-09
Start date
2021-04-19
Completion date
2022-12-31
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Screening Colonoscopy

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.

Interventions

ENDO-AID CADe will be used during the withdrawal process of the colonoscopy.

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Endoscopist wil not be blinded to treatment. Treatment arm allocation will be concealed to patients, data collector and data analysts.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Aged 18 years old or above; 2. They require elective colonoscopy for colorectal cancer screening, polyp surveillance, or investigation of symptoms such as anemia or gastrointestinal bleeding; 3. Written informed consent obtained.

Exclusion criteria

1. Contraindication to colonoscopy (e.g. intestinal obstruction or perforation) 2. Contraindication or conditions precluding polyp resection (e.g. active gastrointestinal bleeding, significant bleeding tendency, uninterrupted anticoagulation or dual antiplatelets) 3. Scheduled staged procedure for polypectomy or biopsy 4. Previous colonic resection 5. Personal history of colorectal cancer 6. Personal history of polyposis syndrome 7. Personal history of inflammatory bowel disease 8. Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above) 9. Pregnancy 10. Unable to obtain informed consent

Design outcomes

Primary

MeasureTime frameDescription
ADRDuring the colonoscopyadenoma detection rate

Secondary

MeasureTime frameDescription
ADR for adenomas of different colonic segmentsDuring the colonoscopycaecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid colon, rectum
Mean number of adenomas per colonoscopyDuring the colonoscopyMean number of adenomas per colonoscopy
Advanced adenoma detection rateDuring the colonoscopyAdvanced adenoma detection rate
Sessile serrate lesion (SSL) detection rateDuring the colonoscopySessile serrate lesion (SSL) detection rate
Polyp detection rateDuring the colonoscopyPolyp detection rate
Non-neoplastic resection rateDuring the colonoscopydefined as absence of adenoma or SSL within resected specimen
ADR for adenomas of different sizesDuring the colonoscopy\<5mm, 5-10mm, \>10mm
False positive rateDuring the colonoscopydefined as computer artifacts due to colonic mucosal wall or bowel content lasting for \>2 seconds
Cecal intubation timeDuring the colonoscopyCecal intubation time
Withdrawal timeDuring the colonoscopyexcluding interventions
Total procedural timeDuring the colonoscopyTotal procedural time
Percentage of change in ADR in relation to the personal experience in colonoscopyDuring the colonoscopyPercentage of change in ADR in relation to the personal experience in colonoscopy based on number of procedures performed \<200 vs 200-500
Missed polyp rateDuring the colonoscopydefined as a polyp which the junior endoscopist fails to recognize and withdraws the endoscope to next colonic segment, but detected by the supervisor

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026