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Endocuff With or Without AI-assisted Colonoscopy

Primary Purpose

Colonic Adenoma, Colonic Polyp, Colonic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Endocuff with AI
AI alone
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonic Adenoma focused on measuring Artificial intelligence, Colonoscopy, Endocuff, Detection, Computer-aided

Eligibility Criteria

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

Inclusion Criteria:

  • All adult patients, aged 40 or above, undergoing outpatient colonoscopy in the Queen Mary Hospital in Hong Kong will be recruited.

Exclusion Criteria:

  • Patients will be excluded if they have history of inflammatory bowel disease, colorectal cancer, previous bowel resection, Peutz-Jeghers syndrome, familial adenomatous polyposis or other polyposis syndromes, bleeding tendency or severe comorbid illnesses for which polypectomy is considered unsafe. Moreover, after randomization, if the cecum could not be intubated for various reasons or Boston Bowel Preparation Scale (BBPS) score is <2, these patients will be excluded

Sites / Locations

  • Queen Mary HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Endocuff- AI assisted colonoscopy

AI-assisted colonoscopy

Conventional colonoscopy

Arm Description

Endocuff (Olympus, Hong Kong) and AI assisted colonoscopy will be used

AI assisted colonoscopy will be used

Conventional colonoscopy will be used without AI or Endocuff.

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 adenomas detection rate
The proportion of patients with at least one sessile serrated adenomas
Sessile serrated polyps detection rate
The proportion of patients with at least one sessile serrated polyps
Advanced adenoma detection rates
The proportion of patients with at least one advanced adenomas
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
November 12, 2021
Last Updated
April 4, 2023
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05133544
Brief Title
Endocuff With or Without AI-assisted Colonoscopy
Official Title
Endocuff With or Without Artificial Intelligence-assisted Colonoscopy in Detection of Colorectal Adenoma: a Randomized Colonoscopy Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Colonoscopy is considered the gold standard for diagnosis of colonic polyps. However, it was reported that colonoscopy could still miss colonic polyps. Many attempts have been made to improve the detection rate of colonoscopy. Artificial intelligence (AI) is a promising new technique to improve detection rate of colonic adenoma. However, it remains uncertain whether whether the combined use of Endocuff and AI assisted examination could help to further improve the adenoma detection rate. This is a prospective randomized trial comparing the use of endocuff with AI, AI alone or conventional colonoscopy examination on adenoma detection rate.
Detailed Description
TThis is a prospective randomized tandem colonoscopy trial comparing three different modes of colonoscopy techniques. The first group will use Endocuff (Olympus, Hong Kong) and AI assisted colonoscopy. The second group will use AI assisted colonoscopy alone and the third group will use standard high-definition white light colonoscopy. Eligible patients will be randomly allocated in a 1:1:1 ratio to three groups. Patients will be stratified according to indications of colonoscopy (symptomatic vs screening/surveillance). All examination will be performed with high-definition endoscopes (EVIS-EXERA 290 video system, Olympus Optical, Tokyo, Japan) under white light by experienced endoscopists. All endoscopists should have received training on the interpretation of real-time AI detection system as well as the Endocuff before performing study colonoscopy. In all colonoscopy examination, colonoscope will be first advanced to the cecum as confirmed by identification of the appendiceal orifice and ileocecal valve or by intubation of the ileum. After cecal intubation is performed, the colonoscopy is first withdrawn according to the group assigned. For group 1, the first withdrawal would be done with Endocuff and AI assistance. For group 2, the first withdrawal would be done under AI assistance only. For group 3, the first withdrawal would be done under standard high definition colonoscopy only. All detected polyps will be removed during the withdrawal only. The size (measured with biopsy forceps), location and morphology of each polyp will be recorded by an independent observer. The withdrawal time (minus the polypectomy site) will be measured by a stopwatch and with a minimum of 6 minutes. The bowel preparation quality will be graded according to the Boston Bowel Preparation Scale

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Adenoma, Colonic Polyp, Colonic Cancer
Keywords
Artificial intelligence, Colonoscopy, Endocuff, Detection, Computer-aided

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Endocuff- AI assisted colonoscopy
Arm Type
Active Comparator
Arm Description
Endocuff (Olympus, Hong Kong) and AI assisted colonoscopy will be used
Arm Title
AI-assisted colonoscopy
Arm Type
Active Comparator
Arm Description
AI assisted colonoscopy will be used
Arm Title
Conventional colonoscopy
Arm Type
No Intervention
Arm Description
Conventional colonoscopy will be used without AI or Endocuff.
Intervention Type
Device
Intervention Name(s)
Endocuff with AI
Intervention Description
Use of endocuff with computer assisted polyp detection
Intervention Type
Device
Intervention Name(s)
AI alone
Intervention Description
Use of computer assisted polyp detection
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 adenomas detection rate
Description
The proportion of patients with at least one sessile serrated adenomas
Time Frame
One month after colonoscopy
Title
Sessile serrated polyps detection rate
Description
The proportion of patients with at least one sessile serrated polyps
Time Frame
One month after colonoscopy
Title
Advanced adenoma detection rates
Description
The proportion of patients with at least one advanced adenomas
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: All adult patients, aged 40 or above, undergoing outpatient colonoscopy in the Queen Mary Hospital, Tung Wah Hospital and Tuen Mun Hospital in Hong Kong will be recruited. Exclusion Criteria: Patients will be excluded if they have history of inflammatory bowel disease, colorectal cancer, previous bowel resection, Peutz-Jeghers syndrome, familial adenomatous polyposis or other polyposis syndromes, bleeding tendency or severe comorbid illnesses for which polypectomy is considered unsafe. Moreover, after randomization, if the cecum could not be intubated for various reasons or Boston Bowel Preparation Scale (BBPS) score is <2, these patients will be excluded
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ka Luen, Thomas Lui, MBBS
Phone
22554048
Email
klluitc@yahoo.com.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wai Keung Leung, MD
Organizational Affiliation
The University of Hong Kong
Official's Role
Study Director
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas K Lui, MBBS

12. IPD Sharing Statement

Plan to Share IPD
No

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Endocuff With or Without AI-assisted Colonoscopy

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