Artificial Intelligence-assisted Colonoscopy With or Without Endocuff Vision
- Conditions
- Adenoma Detection Rate
- Interventions
- Device: Artificial intelligenceDevice: Endocuff visionDevice: High-definition endoscope
- Registration Number
- NCT05863208
- Lead Sponsor
- E-DA Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Artificial Intelligence-assisted Colonoscopy with Endocuff Vision Endocuff vision Use artificial intelligence-assisted colonoscopy with Endocuff Vision Artificial Intelligence-assisted Colonoscopy with Endocuff Vision Artificial intelligence Use artificial intelligence-assisted colonoscopy with Endocuff Vision Artificial Intelligence-assisted Colonoscopy High-definition endoscope Use artificial intelligence-assisted colonoscopy alone Standard colonoscopy High-definition endoscope Use standard colonoscopy without artificial intelligence-assisted colonoscopy or Endocuff Vision Artificial Intelligence-assisted Colonoscopy with Endocuff Vision High-definition endoscope Use artificial intelligence-assisted colonoscopy with Endocuff Vision Artificial Intelligence-assisted Colonoscopy Artificial intelligence Use artificial intelligence-assisted colonoscopy alone
- Primary Outcome Measures
Name Time Method Adenoma detection rate One month after colonoscopy The proportion of patients with at least one adenomas
- Secondary Outcome Measures
Name Time Method Polyp detection rate One month after colonoscopy The proportion of patients with at least one polyp
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
Mean number of polyp per patient One month after colonoscopy The mean number of polyp per patient
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
Trial Locations
- Locations (1)
E-DA Hospital
🇨🇳Kaohsiung City, Taiwan