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

Screening Colonoscopy Clinical Trial

— ENDOAIDTRAIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04838951
• Other study ID #: 2021.141
• Status: Completed
• Phase: N/A
• Start date: April 19, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 856
• Est. completion date: December 31, 2022
• Est. primary completion date: July 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Screening Colonoscopy

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Shatin	New Territories

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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