Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Chung Shan Medical University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artificial Intelligence-assisted Colonoscopy with Endocuff Vision | Active Comparator | Use artificial intelligence-assisted colonoscopy with Endocuff Vision |
|
| Artificial Intelligence-assisted Colonoscopy | Active Comparator | Use artificial intelligence-assisted colonoscopy alone |
|
| Standard colonoscopy | Sham Comparator | Use standard colonoscopy without artificial intelligence-assisted colonoscopy or Endocuff Vision |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial intelligence | Device | ASUS EndoAim AI Endoscopy System (ASUS, Taiwan) is used to help the detection of colon adenoma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma detection rate | The proportion of patients with at least one adenomas | One month after colonoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Polyp detection rate | The proportion of patients with at least one polyp | One month after colonoscopy |
| Sessile serrated adenoma detection rate | The proportion of patients with at least one sessile serrated adenoma |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Nan Tsai, MD | Contact | +88676150022 | 252294 | littlepig9933@gmail.com |
| Wen-Lun Wang, Ph.D | Contact | +88676150022 | 251346 | warrengodr@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ying Nan Tsai, MD | Division of Gastroenterology and Hepatology, E-Da Cancer Hospital, Kaohsiung, Taiwan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| E-DA Hospital | Recruiting | Kaohsiung City | 82445 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28898920 | Background | 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. | |
| 28763808 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Endocuff vision | Device | Endocuff vision (Olympus, UK) is used to help the detection of colon adenoma |
|
| High-definition endoscope | Device | High-definition endoscope (EVIS-EXERA 290 video system, Olympus Optical, Aizu, Japan) is used under white light for the detection of colon adenoma |
|
| One month after colonoscopy |
| Sessile serrated polyps detection rate | The proportion of patients with at least one sessile serrated polyp | One month after colonoscopy |
| Advanced adenoma detection rate | The proportion of patients with at least one advanced adenoma | One month after colonoscopy |
| Mean number of polyp per patient | The mean number of polyp per patient | One month after colonoscopy |
| Mean number of adenoma per patient | The mean number of adenoma per patient | One month after colonoscopy |
| Total number of polyp or adenoma per patient | The total number of polyp or adenoma per patient | One month after colonoscopy |
| 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. |
| 29698990 | Background | 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. |
| 35863686 | Background | 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. |
| 32598963 | Background | 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. |