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

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.

Study Overview

• Status: Completed
• Conditions: Screening Colonoscopy
• Intervention / Treatment: Device: ENDO-AID CADe

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 Type: Interventional
• Enrollment (Actual): 856
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • New Territories
    • Shatin, New Territories, Hong Kong
      • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention arm; CADe system will be used during withdrawal phase of colonoscopy.	Device: ENDO-AID CADe; ENDO-AID CADe will be used during the withdrawal process of the colonoscopy.
NO_INTERVENTION: Control arm; Colonoscopy will be performed according to hospital protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADR	adenoma detection rate	During the colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADR for adenomas of different sizes	<5mm, 5-10mm, >10mm	During the colonoscopy
ADR for adenomas of different colonic segments	caecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid colon, rectum	During the colonoscopy
Mean number of adenomas per colonoscopy	Mean number of adenomas per colonoscopy	During the colonoscopy
Advanced adenoma detection rate	Advanced adenoma detection rate	During the colonoscopy
Polyp detection rate	Polyp detection rate	During the colonoscopy
Withdrawal time	excluding interventions	During the colonoscopy
Total procedural time	Total procedural time	During the colonoscopy
False positive rate	defined as computer artifacts due to colonic mucosal wall or bowel content lasting for >2 seconds	During the colonoscopy
Sessile serrate lesion (SSL) detection rate	Sessile serrate lesion (SSL) detection rate	During the colonoscopy
Non-neoplastic resection rate	defined as absence of adenoma or SSL within resected specimen	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	During the colonoscopy
Cecal intubation time	Cecal intubation time	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	During the colonoscopy

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 19, 2021
• Primary Completion (ACTUAL): July 22, 2022
• Study Completion (ACTUAL): December 31, 2022

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (ACTUAL): April 9, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: 2021.141

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No