Department of Surgery, Chinese University of Hong Kong
Shatin, New Territories, Hong Kong
NCT Number: NCT05013125
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Shatin, New Territories, Hong Kong
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ENDO-AID is a dedicated endoscopy Computer-Aided Diagnosis (CADe) system where suspicious lesions are automatically detected and highlighted on the main monitor in real-time, alerting the endoscopist during the procedure.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: End of study, about 1 year
To compare the number of polyps removed between ENDO-AID assisted Colonoscopy and conventional white light colonoscopy
Time frame: End of study, about 1 year
Baseline Parameters will be compared, including withdrawal time and Boston Bowel Preparation Scale in the first colonoscopy procedures
Time frame: At 30 days
To compare the Serious Adverse Events between ENDO-AID assisted Colonoscopy and conventional white light colonoscopy
Time frame: End of study, about 1 year
Number of abnormalities highlighted on ENDO-AID and actual number of abnormalities found macroscopically and histologically
Chinese University of Hong Kong
Other
Assessment of Efficacy of ENDO-AID Assisted Colonoscopy in Adenoma Detection: a Single Centre Randomised Controlled Trial
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