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

• ClinicalTrials.gov Identifier: NCT04838951
• Recruitment Status: Completed
• First Posted: April 9, 2021
• Last Update Posted: February 8, 2023
• Sponsor: Chinese University of Hong Kong
• Information provided by (Responsible Party): Louis Ho Shing Lau, Chinese University of Hong Kong

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Screening Colonoscopy	Device: ENDO-AID CADe	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 856 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Endoscopist wil not be blinded to treatment. Treatment arm allocation will be concealed to patients, data collector and data analysts.
• Primary Purpose: Treatment
• Official Title: Effect of Real-time Computer-aided System (ENDO-AID) on Adenoma Detection in Endoscopist-in-training: a Single-blind Randomized Study
• Actual Study Start Date: April 19, 2021
• Actual Primary Completion Date: July 22, 2022
• Actual Study Completion Date: December 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. ADR [ Time Frame: During the colonoscopy ]
   adenoma detection rate

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Hong Kong

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Sponsors and Collaborators

Chinese University of Hong Kong

More Information

• Responsible Party: Louis Ho Shing Lau, Resident Specialist, Chinese University of Hong Kong
• ClinicalTrials.gov Identifier: NCT04838951
• Other Study ID Numbers: 2021.141
• First Posted: April 9, 2021
• Last Update Posted: February 8, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: There is no plan to share individual participant data to other researchers

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms