ENDO-AID Assisted Tandem Colonoscopy RCT

Not Applicable

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Diagnostic Test: ENDO-AID CADe assisted Colonoscopy

• Registration Number: NCT05013125
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

This study hypothesizes that more adenomas will be detected using the ENDO-AID assisted Colonoscopy compared to conventional colonoscopy.

A single-centre, randomized, same-day, back-to-back tandem colonoscopy trial comparing Adenoma Missed Rate and Adenoma Detection Rate in ENDO-AID assisted colonoscopy and conventional colonoscopy.

Detailed Description

Colorectal cancer is the third common cancer in the world and the commonest cancer in Hong Kong. Most sporadic colorectal cancers arise from benign polyps via adenoma-carcinoma sequence or the serrated polyp-carcinoma sequence. There are reports of unexpectedly high risk of interval carcinomas, as high as up to 9%, raising concerns about the effectiveness of colonoscopy in preventing colorectal cancers. Different techniques have been described to improve the area of mucosa visualised but lesions may still be missed due to failure of identification by the endoscopist.

Computer Aided diagnosis (CAD) assisted colonoscopy is becoming increasingly popular to address human error. Deep learning technology has surpassed human learning and advancement in technology now allows real-time Artificial Intelligence to assist colonoscopists in polyp detection.

Study Timeline

• Study First Submitted: 2021-07-26
• Study First Submitted QC: 2021-08-13
• Study Start: 2021-08-18
• Study First Posted: 2021-08-19
• Primary Completion: 2023-03-17
• Study Completion: 2023-04-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Patients aged 18years or above
• Referred to endoscopy unit for diagnostic or surveillance colonoscopy

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Exclusion Criteria

• Familial history of Familial adenomatous polyposis / Hereditary non-polyposis colorectal cancer
• Known history of inflammatory bowel disease
• Known colitis or suspicion of colitis (inflammatory bowel disease, diverticulitis, infective colitis)
• Emergency endoscopy of any nature (eg gastrointestinal bleeding, colonic decompression)
• Previous incomplete colonoscopy (not including insufficient preparation) / difficult colonoscopy
• Patients referred for a therapeutic procedure or assessment of a known non-resected lesion
• Patients with known palliative colorectal malignancy
• Patient with coagulopathy
• Patient with colostomy
• Patient with multiple co-morbidities (American Society of Anaesthesiologist >3)
• Inability to give informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ENDO-AID assisted Colonoscopy - ENDO-AID assisted Colonoscopy	ENDO-AID CADe assisted Colonoscopy	Patients will undergo ENDO-AID assisted colonoscopy with all polyps treated as per usual practice, followed back to back by ENDO-AID assisted colonoscopy

Primary Outcome Measures

Name	Time	Method
Adenoma missed rate	End of study, about 1 year	To compare the adenoma missed rate (AMR) between ENDO-AID assisted Colonoscopy and conventional colonoscopy. AMR is defined as the number of adenomas detected in the second pass colonoscopy divided by the total number of adenomas detected in both passes for the same patients.

Secondary Outcome Measures

Name	Time	Method
Patient missed rate	End of study, about 1 year	To compare the patient missed rate (PMR) between ENDO-AID assisted colonoscopy and conventional white light colonoscopy. PMR is defined as the number of patients in whom adenomas were detected for the first time during second pass colonoscopy divided by the number of patients with at least 1 adenoma detected.
Serious Adverse Events	At 30 days	To compare the Serious Adverse Events between ENDO-AID assisted Colonoscopy and conventional white light colonoscopy
Adenoma detection rate	End of study, about 1 year	To compare the Adenoma detection rate (ADR) between ENDO-AID assisted Colonoscopy and conventional colonoscopy for the first pass colonoscopy. ADR is defined as the proportion of patients with at least 1 adenoma detected in the first pass colonoscopy.
Number of polyps removed	End of study, about 1 year	To compare the number of polyps removed between ENDO-AID assisted Colonoscopy and conventional white light colonoscopy
Baseline Parameters	End of study, about 1 year	Baseline Parameters will be compared, including withdrawal time and Boston Bowel Preparation Scale in the first colonoscopy procedures
Polyp missed rate	End of study, about 1 year	To compare the Polyp missed rate (PMR) between ENDO-AID assisted Colonoscopy and conventional colonoscopy. PMR is defined as the number of polyps detected in the second pass colonoscopy divided by the total number of polyps detected in both passes for the same patients.
Number of CAD assisted abnormality	End of study, about 1 year	Number of abnormalities highlighted on ENDO-AID and actual number of abnormalities found macroscopically and histologically

Trial Locations

Locations (1)

Department of Surgery, Chinese University of Hong Kong; 🇭🇰 Shatin, New Territories, Hong Kong