Assessment of Efficacy of ENDO-AID Assisted Colonoscopy in Adenoma Detection: a Single Centre Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 360
- Locations
- 1
- Primary Endpoint
- Adenoma missed rate
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged 18years or above
- •Referred to endoscopy unit for diagnostic or surveillance colonoscopy
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
Arms & Interventions
Conventional Colonoscopy - ENDO-AID assisted Colonoscopy
Patients will undergo usual colonoscopy as per usual practice, followed back to back by ENDO-AID assisted colonoscopy
ENDO-AID assisted Colonoscopy - ENDO-AID 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
Intervention: ENDO-AID CADe assisted Colonoscopy (Diagnostic Test)
Outcomes
Primary Outcomes
Adenoma missed rate
Time Frame: 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 Outcomes
- Patient missed rate(End of study, about 1 year)
- Serious Adverse Events(At 30 days)
- Adenoma detection rate(End of study, about 1 year)
- Number of polyps removed(End of study, about 1 year)
- Baseline Parameters(End of study, about 1 year)
- Polyp missed rate(End of study, about 1 year)
- Number of CAD assisted abnormality(End of study, about 1 year)
Investigators
Kaori Futaba
Assistant Professor
Chinese University of Hong Kong