Clinical trial NCT05013125: ENDO-AID Assisted Tandem Colonoscopy RCT
Official title: Assessment of Efficacy of ENDO-AID Assisted Colonoscopy in Adenoma Detection: a Single Centre Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Keywords: Computer aided Polyp detection
Colonoscopy
Polyp detection
Colorectal polyps
Colorectal cancer
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adenoma missed rate
timeFrame: End of study, about 1 year
Secondary outcomes:
measure: Polyp missed rate
timeFrame: End of study, about 1 year
measure: Adenoma detection rate
timeFrame: End of study, about 1 year
measure: Patient missed rate
timeFrame: End of study, about 1 year
measure: Number of polyps removed
timeFrame: End of study, about 1 year
measure: Baseline Parameters
timeFrame: End of study, about 1 year
measure: Serious Adverse Events
timeFrame: At 30 days
measure: Number of CAD assisted abnormality
timeFrame: End of study, about 1 year
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Department of Surgery, Chinese University of Hong Kong
state: New Territories
Study officials:
affiliation: Chinese University of Hong Kong
name: Kaori Futaba
role: PRINCIPAL_INVESTIGATOR
References: