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Completed

NCT Number: NCT04838951

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

The investigator's hypothesis is that a CADe system (ENDO-AID) would improve the adenoma detection rate in junior endoscopists.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

ENDO-AID CADe

Device

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

Primary outcomes

  1. ADR

    Time frame: During the colonoscopy

    adenoma detection rate

Secondary outcomes

  1. ADR for adenomas of different sizes

    Time frame: During the colonoscopy

    <5mm, 5-10mm, >10mm

  2. ADR for adenomas of different colonic segments

    Time frame: During the colonoscopy

    caecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid colon, rectum

  3. Mean number of adenomas per colonoscopy

    Time frame: During the colonoscopy

    Mean number of adenomas per colonoscopy

  4. Advanced adenoma detection rate

    Time frame: During the colonoscopy

    Advanced adenoma detection rate

  5. Sessile serrate lesion (SSL) detection rate

    Time frame: During the colonoscopy

    Sessile serrate lesion (SSL) detection rate

  6. Polyp detection rate

    Time frame: During the colonoscopy

    Polyp detection rate

  7. Non-neoplastic resection rate

    Time frame: During the colonoscopy

    defined as absence of adenoma or SSL within resected specimen

  8. Missed polyp rate

    Time frame: During the colonoscopy

    defined as a polyp which the junior endoscopist fails to recognize and withdraws the endoscope to next colonic segment, but detected by the supervisor

  9. False positive rate

    Time frame: During the colonoscopy

    defined as computer artifacts due to colonic mucosal wall or bowel content lasting for >2 seconds

  10. Cecal intubation time

    Time frame: During the colonoscopy

    Cecal intubation time

  11. Withdrawal time

    Time frame: During the colonoscopy

    excluding interventions

  12. Total procedural time

    Time frame: During the colonoscopy

    Total procedural time

  13. Percentage of change in ADR in relation to the personal experience in colonoscopy

    Time frame: During the colonoscopy

    Percentage of change in ADR in relation to the personal experience in colonoscopy based on number of procedures performed <200 vs 200-500

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Acronym: ENDOAIDTRAIN

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 9, 2021
Registry last updated
Feb 8, 2023

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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