Artificial Intelligence-assisted Colonoscopy With or Without Endocuff Vision
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Artificial Intelligence-assisted Colonoscopy with Endocuff Vision Use artificial intelligence-assisted colonoscopy with Endocuff Vision |
Device: Artificial intelligence
ASUS EndoAim AI Endoscopy System (ASUS, Taiwan) is used to help the detection of colon adenoma
Device: Endocuff vision
Endocuff vision (Olympus, UK) is used to help the detection of colon adenoma
Device: High-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
|
| Active Comparator: Artificial Intelligence-assisted Colonoscopy Use artificial intelligence-assisted colonoscopy alone |
Device: Artificial intelligence
ASUS EndoAim AI Endoscopy System (ASUS, Taiwan) is used to help the detection of colon adenoma
Device: High-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
|
| Sham Comparator: Standard colonoscopy Use standard colonoscopy without artificial intelligence-assisted colonoscopy or Endocuff Vision |
Device: High-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
|
Outcome Measures
Primary Outcome Measures
- Adenoma detection rate [One month after colonoscopy]
The proportion of patients with at least one adenomas
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
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
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Bleeding tendency
-
For scheduled endoscopic treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | E-DA Hospital | Kaohsiung City | Taiwan | 82445 |
Sponsors and Collaborators
- E-DA Hospital
- Chung Shan Medical University
Investigators
- Study Chair: Ying Nan Tsai, MD, Division of Gastroenterology and Hepatology, E-Da Cancer Hospital, Kaohsiung, Taiwan
Study Documents (Full-Text)
None provided.More Information
Publications
- Gonzalez-Fernandez C, Garcia-Rangel D, Aguilar-Olivos NE, Barreto-Zuniga R, Romano-Munive AF, Grajales-Figueroa G, Zamora-Nava LE, Tellez-Avila FI. Higher adenoma detection rate with the endocuff: a randomized trial. Endoscopy. 2017 Nov;49(11):1061-1068. doi: 10.1055/s-0043-117879. Epub 2017 Sep 12.
- Hassan C, Spadaccini M, Iannone A, Maselli R, Jovani M, Chandrasekar VT, Antonelli G, Yu H, Areia M, Dinis-Ribeiro M, Bhandari P, Sharma P, Rex DK, Rosch T, Wallace M, Repici A. Performance of artificial intelligence in colonoscopy for adenoma and polyp detection: a systematic review and meta-analysis. Gastrointest Endosc. 2021 Jan;93(1):77-85.e6. doi: 10.1016/j.gie.2020.06.059. Epub 2020 Jun 26.
- Triantafyllou K, Polymeros D, Apostolopoulos P, Lopes Brandao C, Gkolfakis P, Repici A, Papanikolaou IS, Dinis-Ribeiro M, Alexandrakis G, Hassan C. Endocuff-assisted colonoscopy is associated with a lower adenoma miss rate: a multicenter randomized tandem study. Endoscopy. 2017 Nov;49(11):1051-1060. doi: 10.1055/s-0043-114412. Epub 2017 Aug 1.
- Williet N, Tournier Q, Vernet C, Dumas O, Rinaldi L, Roblin X, Phelip JM, Pioche M. Effect of Endocuff-assisted colonoscopy on adenoma detection rate: meta-analysis of randomized controlled trials. Endoscopy. 2018 Sep;50(9):846-860. doi: 10.1055/a-0577-3500. Epub 2018 Apr 26.
- Xu H, Tang RSY, Lam TYT, Zhao G, Lau JYW, Liu Y, Wu Q, Rong L, Xu W, Li X, Wong SH, Cai S, Wang J, Liu G, Ma T, Liang X, Mak JWY, Xu H, Yuan P, Cao T, Li F, Ye Z, Shutian Z, Sung JJY. Artificial Intelligence-Assisted Colonoscopy for Colorectal Cancer Screening: A Multicenter Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2023 Feb;21(2):337-346.e3. doi: 10.1016/j.cgh.2022.07.006. Epub 2022 Jul 19.
- EMRP53109N