Artificial Intelligence-assisted Colonoscopy With or Without Endocuff Vision

Adenoma Detection Rate Clinical Trial

Official title:

Comparison of The Adenoma Detection Rate Between Artificial Intelligence-assisted Colonoscopy With or Without Endocuff Vision and Standard Colonscopy: A Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05863208
• Other study ID #: EMRP53109N
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2023
• Source: E-DA Hospital
• Contact: Ying Nan Tsai, MD
• Phone: +88676150022
• Email: littlepig9933[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adenoma Detection Rate

Intervention

Device:
• Artificial intelligence
ASUS EndoAim AI Endoscopy System (ASUS, Taiwan) is used to help the detection of colon adenoma
• Endocuff vision
Endocuff vision (Olympus, UK) is used to help the detection of colon adenoma
• 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

Locations

Country	Name	City	State
Taiwan	E-DA Hospital	Kaohsiung City

Sponsors (2)

Lead Sponsor	Collaborator
E-DA Hospital	Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma detection rate	The proportion of patients with at least one adenomas	One month after colonoscopy
Secondary	Polyp detection rate	The proportion of patients with at least one polyp	One month after colonoscopy
Secondary	Sessile serrated adenoma detection rate	The proportion of patients with at least one sessile serrated adenoma	One month after colonoscopy
Secondary	Sessile serrated polyps detection rate	The proportion of patients with at least one sessile serrated polyp	One month after colonoscopy
Secondary	Advanced adenoma detection rate	The proportion of patients with at least one advanced adenoma	One month after colonoscopy
Secondary	Mean number of polyp per patient	The mean number of polyp per patient	One month after colonoscopy
Secondary	Mean number of adenoma per patient	The mean number of adenoma per patient	One month after colonoscopy
Secondary	Total number of polyp or adenoma per patient	The total number of polyp or adenoma per patient	One month after colonoscopy