Clinical trial NCT05863208: Artificial Intelligence-assisted Colonoscopy With or Without Endocuff Vision
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adenoma Detection Rate
Lead sponsor: E-DA Hospital
Sponsor class: OTHER
Collaborators: name: Chung Shan Medical University
First posted: 2023-05-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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
* Bleeding tendency
* For scheduled endoscopic treatment

Primary outcomes:
measure: Adenoma detection rate
timeFrame: One month after colonoscopy
Secondary outcomes:
measure: Polyp detection rate
timeFrame: One month after colonoscopy
measure: Sessile serrated adenoma detection rate
timeFrame: One month after colonoscopy
measure: Sessile serrated polyps detection rate
timeFrame: One month after colonoscopy
measure: Advanced adenoma detection rate
timeFrame: One month after colonoscopy
measure: Mean number of polyp per patient
timeFrame: One month after colonoscopy
measure: Mean number of adenoma per patient
timeFrame: One month after colonoscopy
measure: Total number of polyp or adenoma per patient
timeFrame: One month after colonoscopy
Other outcomes:
Locations:
city: Kaohsiung City
country: Taiwan
facility: E-DA Hospital
Study officials:
affiliation: Division of Gastroenterology and Hepatology, E-Da Cancer Hospital, Kaohsiung, Taiwan
name: Ying Nan Tsai, MD
role: STUDY_CHAIR
References:
citation: 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.
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.
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