ENDO-AID Assisted Tandem Colonoscopy RCT

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessment of Efficacy of ENDO-AID Assisted Colonoscopy in Adenoma Detection: a Single Centre Randomised Controlled Trial

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Diagnostic Test: ENDO-AID CADe assisted Colonoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional Colonoscopy - ENDO-AID assisted Colonoscopy<br>Patients will undergo usual colonoscopy as per usual practice, followed back to back by ENDO-AID assisted colonoscopy | |
| Active Comparator: ENDO-AID assisted Colonoscopy - ENDO-AID assisted Colonoscopy<br>Patients will undergo ENDO-AID assisted colonoscopy with all polyps treated as per usual practice, followed back to back by ENDO-AID assisted colonoscopy | Diagnostic Test: ENDO-AID CADe assisted Colonoscopy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma missed rate | 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. | End of study, about 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyp missed rate | 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. | End of study, about 1 year | 
| Adenoma detection rate | 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. | End of study, about 1 year | 
| Patient missed rate | 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. | End of study, about 1 year | 
| Number of polyps removed | To compare the number of polyps removed between ENDO-AID assisted Colonoscopy and conventional white light colonoscopy | End of study, about 1 year | 
| Baseline Parameters | Baseline Parameters will be compared, including withdrawal time and Boston Bowel Preparation Scale in the first colonoscopy procedures | End of study, about 1 year | 
| Serious Adverse Events | To compare the Serious Adverse Events between ENDO-AID assisted Colonoscopy and conventional white light colonoscopy | At 30 days | 
| Number of CAD assisted abnormality | Number of abnormalities highlighted on ENDO-AID and actual number of abnormalities found macroscopically and histologically | End of study, about 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer, Computer aided Polyp detection, Colonoscopy, Polyp detection, Colorectal polyps