Adenoma Detection Rate
Conditions
Brief summary
Adenoma detection rate (ADR) is considered the single most important quality measure in colonoscopy and a higher ADR can reduce the risk of interval colorectal cancer (CRC). Several kinds of new endoscopes and accessories have been accessed to investigate the abilities of improving the ADR. Artificial intelligence (AI) and Endocuff vision are promising new devices to improve the ADR. However, the effect of combining AI and Endocuff vision on ADR remains unclear. The aim of this prospective randomized study is to compare the ADR of AI plus Endocuff vision, AI alone and standard colonoscopy examination.
Detailed description
This is a prospective single-blinded randomized controlled trial of three different types of colonoscopy examinations by 1:1:1 ratio. We use EndoAim AI (ASUS, Taiwan) and Endocuff vision (Olympus, UK) assisted colonoscopy in the first group. We use AI assisted colonoscopy in the 2nd group. We use standard colonoscopy in the 3rd group. Eligible patients are older than 40 years old and receive colonoscopy for either symptomatic or screening/surveillance. All endoscopists should receive training on EndoAim AI systems and Endocuff vision. During the procedure, experienced endoscopists use high-definition endoscopes (EVIS-EXERA 290 video system, Olympus Optical, Aizu, Japan) under white light and insert to the cecum in the three different groups. The cecal intubation is confirmed by the identification of ileocecal valve and appendiceal orifice. The Boston Bowel Preparation Scale is used for grading the bowel preparation quality. The size (compared with biopsy forceps), location and morphology of polyps are recorded by the independent endoscopist. All polyps ae removed by either biopsy or polypectomy. The insertion and withdrawal time are measured. The time of the polypectomy site is not included in the withdrawal time.
Interventions
DEVICEArtificial intelligence
ASUS EndoAim AI Endoscopy System (ASUS, Taiwan) is used to help the detection of colon adenoma
DEVICEEndocuff vision
Endocuff vision (Olympus, UK) is used to help the detection of colon adenoma
DEVICEHigh-definition endoscope
High-definition endoscope (EVIS-EXERA 290 video system, Olympus Optical, Aizu, Japan) is used under white light for the detection of colon adenoma
Sponsors
Chung Shan Medical University
E-DA Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients over 20 years old are undergoing outpatient sedative colonoscopy in the E-Da Hospital, E-Da cancer Hospital and Chung Shan Medical University Hospital in Taiwan
Exclusion criteria
* A prior history of of inflammatory bowel disease, colorectal cancer, previous bowel resection, Peutz-Jeghers syndrome, familial adenomatous polyposis or other polyposis syndromes * Bleeding tendency * For scheduled endoscopic treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma detection rate | One month after colonoscopy | The proportion of patients with at least one adenomas |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sessile serrated adenoma detection rate | One month after colonoscopy | The proportion of patients with at least one sessile serrated adenoma |
| Sessile serrated polyps detection rate | One month after colonoscopy | The proportion of patients with at least one sessile serrated polyp |
| Advanced adenoma detection rate | One month after colonoscopy | The proportion of patients with at least one advanced adenoma |
| Polyp detection rate | One month after colonoscopy | The proportion of patients with at least one polyp |
| Mean number of adenoma per patient | One month after colonoscopy | The mean number of adenoma per patient |
| Total number of polyp or adenoma per patient | One month after colonoscopy | The total number of polyp or adenoma per patient |
| Mean number of polyp per patient | One month after colonoscopy | The mean number of polyp per patient |
Countries
Taiwan
Contacts
Primary ContactYing Nan Tsai, MD
Backup ContactWen-Lun Wang, Ph.D
Outcome results
None listed