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Artificial Intelligence-assisted Colonoscopy With or Without Endocuff Vision

Primary Purpose

Adenoma Detection Rate

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Artificial intelligence
Endocuff vision
High-definition endoscope
Sponsored by
E-DA Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adenoma Detection Rate

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • E-DA HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Artificial Intelligence-assisted Colonoscopy with Endocuff Vision

Artificial Intelligence-assisted Colonoscopy

Standard colonoscopy

Arm Description

Use artificial intelligence-assisted colonoscopy with Endocuff Vision

Use artificial intelligence-assisted colonoscopy alone

Use standard colonoscopy without artificial intelligence-assisted colonoscopy or Endocuff Vision

Outcomes

Primary Outcome Measures

Adenoma detection rate
The proportion of patients with at least one adenomas

Secondary Outcome Measures

Polyp detection rate
The proportion of patients with at least one polyp
Sessile serrated adenoma detection rate
The proportion of patients with at least one sessile serrated adenoma
Sessile serrated polyps detection rate
The proportion of patients with at least one sessile serrated polyp
Advanced adenoma detection rate
The proportion of patients with at least one advanced adenoma
Mean number of polyp per patient
The mean number of polyp per patient
Mean number of adenoma per patient
The mean number of adenoma per patient
Total number of polyp or adenoma per patient
The total number of polyp or adenoma per patient

Full Information

First Posted
May 9, 2023
Last Updated
May 9, 2023
Sponsor
E-DA Hospital
Collaborators
Chung Shan Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05863208
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
E-DA Hospital
Collaborators
Chung Shan Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma Detection Rate

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Artificial Intelligence-assisted Colonoscopy with Endocuff Vision
Arm Type
Active Comparator
Arm Description
Use artificial intelligence-assisted colonoscopy with Endocuff Vision
Arm Title
Artificial Intelligence-assisted Colonoscopy
Arm Type
Active Comparator
Arm Description
Use artificial intelligence-assisted colonoscopy alone
Arm Title
Standard colonoscopy
Arm Type
Sham Comparator
Arm Description
Use standard colonoscopy without artificial intelligence-assisted colonoscopy or Endocuff Vision
Intervention Type
Device
Intervention Name(s)
Artificial intelligence
Intervention Description
ASUS EndoAim AI Endoscopy System (ASUS, Taiwan) is used to help the detection of colon adenoma
Intervention Type
Device
Intervention Name(s)
Endocuff vision
Intervention Description
Endocuff vision (Olympus, UK) is used to help the detection of colon adenoma
Intervention Type
Device
Intervention Name(s)
High-definition endoscope
Intervention Description
High-definition endoscope (EVIS-EXERA 290 video system, Olympus Optical, Aizu, Japan) is used under white light for the detection of colon adenoma
Primary Outcome Measure Information:
Title
Adenoma detection rate
Description
The proportion of patients with at least one adenomas
Time Frame
One month after colonoscopy
Secondary Outcome Measure Information:
Title
Polyp detection rate
Description
The proportion of patients with at least one polyp
Time Frame
One month after colonoscopy
Title
Sessile serrated adenoma detection rate
Description
The proportion of patients with at least one sessile serrated adenoma
Time Frame
One month after colonoscopy
Title
Sessile serrated polyps detection rate
Description
The proportion of patients with at least one sessile serrated polyp
Time Frame
One month after colonoscopy
Title
Advanced adenoma detection rate
Description
The proportion of patients with at least one advanced adenoma
Time Frame
One month after colonoscopy
Title
Mean number of polyp per patient
Description
The mean number of polyp per patient
Time Frame
One month after colonoscopy
Title
Mean number of adenoma per patient
Description
The mean number of adenoma per patient
Time Frame
One month after colonoscopy
Title
Total number of polyp or adenoma per patient
Description
The total number of polyp or adenoma per patient
Time Frame
One month after colonoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Nan Tsai, MD
Phone
+88676150022
Ext
252294
Email
littlepig9933@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wen-Lun Wang, Ph.D
Phone
+88676150022
Ext
251346
Email
warrengodr@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Nan Tsai, MD
Organizational Affiliation
Division of Gastroenterology and Hepatology, E-Da Cancer Hospital, Kaohsiung, Taiwan
Official's Role
Study Chair
Facility Information:
Facility Name
E-DA Hospital
City
Kaohsiung City
ZIP/Postal Code
82445
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Nan Tsai, M.D
Phone
886-7-6150011
Ext
252294
Email
littlepig9933@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28898920
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.
Results Reference
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PubMed Identifier
28763808
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.
Results Reference
background
PubMed Identifier
29698990
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.
Results Reference
background
PubMed Identifier
35863686
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.
Results Reference
background
PubMed Identifier
32598963
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.
Results Reference
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Artificial Intelligence-assisted Colonoscopy With or Without Endocuff Vision

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