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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Colonoscopy - ENDO-AID assisted Colonoscopy | No Intervention | 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 | Active Comparator | Patients will undergo ENDO-AID assisted colonoscopy with all polyps treated as per usual practice, followed back to back by ENDO-AID assisted colonoscopy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENDO-AID CADe assisted Colonoscopy | Diagnostic Test | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kaori Futaba | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Chinese University of Hong Kong | Shatin | New Territories | Hong Kong |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| 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 |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |