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ENDO-AID Assisted Tandem Colonoscopy RCT

Primary Purpose

Colorectal Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
ENDO-AID CADe assisted Colonoscopy
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Neoplasms focused on measuring Computer aided Polyp detection, Colonoscopy, Polyp detection, Colorectal polyps, Colorectal cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Patients aged 18years or above
  • Referred to endoscopy unit for diagnostic or surveillance colonoscopy

Exclusion Criteria:

  • Familial history of Familial adenomatous polyposis / Hereditary non-polyposis colorectal cancer
  • Known history of inflammatory bowel disease
  • Known colitis or suspicion of colitis (inflammatory bowel disease, diverticulitis, infective colitis)
  • Emergency endoscopy of any nature (eg gastrointestinal bleeding, colonic decompression)
  • Previous incomplete colonoscopy (not including insufficient preparation) / difficult colonoscopy
  • Patients referred for a therapeutic procedure or assessment of a known non-resected lesion
  • Patients with known palliative colorectal malignancy
  • Patient with coagulopathy
  • Patient with colostomy
  • Patient with multiple co-morbidities (American Society of Anaesthesiologist >3)
  • Inability to give informed consent

Sites / Locations

  • Department of Surgery, Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Conventional Colonoscopy - ENDO-AID assisted Colonoscopy

ENDO-AID assisted Colonoscopy - ENDO-AID assisted Colonoscopy

Arm Description

Patients will undergo usual colonoscopy as per usual practice, followed back to back by ENDO-AID assisted colonoscopy

Patients will undergo ENDO-AID assisted colonoscopy with all polyps treated as per usual practice, followed back to back by ENDO-AID assisted colonoscopy

Outcomes

Primary Outcome Measures

Adenoma missed rate
To compare the adenoma missed rate (AMR) between ENDO-AID assisted Colonoscopy and conventional colonoscopy. AMR is defined as the number of adenomas detected in the second pass colonoscopy divided by the total number of adenomas detected in both passes for the same patients.

Secondary Outcome Measures

Polyp missed rate
To compare the Polyp missed rate (PMR) between ENDO-AID assisted Colonoscopy and conventional colonoscopy. PMR is defined as the number of polyps detected in the second pass colonoscopy divided by the total number of polyps detected in both passes for the same patients.
Adenoma detection rate
To compare the Adenoma detection rate (ADR) between ENDO-AID assisted Colonoscopy and conventional colonoscopy for the first pass colonoscopy. ADR is defined as the proportion of patients with at least 1 adenoma detected in the first pass colonoscopy.
Patient missed rate
To compare the patient missed rate (PMR) between ENDO-AID assisted colonoscopy and conventional white light colonoscopy. PMR is defined as the number of patients in whom adenomas were detected for the first time during second pass colonoscopy divided by the number of patients with at least 1 adenoma detected.
Number of polyps removed
To compare the number of polyps removed between ENDO-AID assisted Colonoscopy and conventional white light colonoscopy
Baseline Parameters
Baseline Parameters will be compared, including withdrawal time and Boston Bowel Preparation Scale in the first colonoscopy procedures
Serious Adverse Events
To compare the Serious Adverse Events between ENDO-AID assisted Colonoscopy and conventional white light colonoscopy
Number of CAD assisted abnormality
Number of abnormalities highlighted on ENDO-AID and actual number of abnormalities found macroscopically and histologically

Full Information

First Posted
July 26, 2021
Last Updated
August 13, 2021
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05013125
Brief Title
ENDO-AID Assisted Tandem Colonoscopy RCT
Official Title
Assessment of Efficacy of ENDO-AID Assisted Colonoscopy in Adenoma Detection: a Single Centre Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 9, 2021 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

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

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
This study hypothesizes that more adenomas will be detected using the ENDO-AID assisted Colonoscopy compared to conventional colonoscopy. A single-centre, randomized, same-day, back-to-back tandem colonoscopy trial comparing Adenoma Missed Rate and Adenoma Detection Rate in ENDO-AID assisted colonoscopy and conventional colonoscopy.
Detailed Description
Colorectal cancer is the third common cancer in the world and the commonest cancer in Hong Kong. Most sporadic colorectal cancers arise from benign polyps via adenoma-carcinoma sequence or the serrated polyp-carcinoma sequence. There are reports of unexpectedly high risk of interval carcinomas, as high as up to 9%, raising concerns about the effectiveness of colonoscopy in preventing colorectal cancers. Different techniques have been described to improve the area of mucosa visualised but lesions may still be missed due to failure of identification by the endoscopist. Computer Aided diagnosis (CAD) assisted colonoscopy is becoming increasingly popular to address human error. Deep learning technology has surpassed human learning and advancement in technology now allows real-time Artificial Intelligence to assist colonoscopists in polyp detection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
Computer aided Polyp detection, Colonoscopy, Polyp detection, Colorectal polyps, Colorectal cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Conventional Colonoscopy - ENDO-AID assisted Colonoscopy
Arm Type
No Intervention
Arm Description
Patients will undergo usual colonoscopy as per usual practice, followed back to back by ENDO-AID assisted colonoscopy
Arm Title
ENDO-AID assisted Colonoscopy - ENDO-AID assisted Colonoscopy
Arm Type
Active Comparator
Arm Description
Patients will undergo ENDO-AID assisted colonoscopy with all polyps treated as per usual practice, followed back to back by ENDO-AID assisted colonoscopy
Intervention Type
Diagnostic Test
Intervention Name(s)
ENDO-AID CADe assisted Colonoscopy
Intervention Description
ENDO-AID is a dedicated endoscopy Computer-Aided Diagnosis (CADe) system where suspicious lesions are automatically detected and highlighted on the main monitor in real-time, alerting the endoscopist during the procedure.
Primary Outcome Measure Information:
Title
Adenoma missed rate
Description
To compare the adenoma missed rate (AMR) between ENDO-AID assisted Colonoscopy and conventional colonoscopy. AMR is defined as the number of adenomas detected in the second pass colonoscopy divided by the total number of adenomas detected in both passes for the same patients.
Time Frame
End of study, about 1 year
Secondary Outcome Measure Information:
Title
Polyp missed rate
Description
To compare the Polyp missed rate (PMR) between ENDO-AID assisted Colonoscopy and conventional colonoscopy. PMR is defined as the number of polyps detected in the second pass colonoscopy divided by the total number of polyps detected in both passes for the same patients.
Time Frame
End of study, about 1 year
Title
Adenoma detection rate
Description
To compare the Adenoma detection rate (ADR) between ENDO-AID assisted Colonoscopy and conventional colonoscopy for the first pass colonoscopy. ADR is defined as the proportion of patients with at least 1 adenoma detected in the first pass colonoscopy.
Time Frame
End of study, about 1 year
Title
Patient missed rate
Description
To compare the patient missed rate (PMR) between ENDO-AID assisted colonoscopy and conventional white light colonoscopy. PMR is defined as the number of patients in whom adenomas were detected for the first time during second pass colonoscopy divided by the number of patients with at least 1 adenoma detected.
Time Frame
End of study, about 1 year
Title
Number of polyps removed
Description
To compare the number of polyps removed between ENDO-AID assisted Colonoscopy and conventional white light colonoscopy
Time Frame
End of study, about 1 year
Title
Baseline Parameters
Description
Baseline Parameters will be compared, including withdrawal time and Boston Bowel Preparation Scale in the first colonoscopy procedures
Time Frame
End of study, about 1 year
Title
Serious Adverse Events
Description
To compare the Serious Adverse Events between ENDO-AID assisted Colonoscopy and conventional white light colonoscopy
Time Frame
At 30 days
Title
Number of CAD assisted abnormality
Description
Number of abnormalities highlighted on ENDO-AID and actual number of abnormalities found macroscopically and histologically
Time Frame
End of study, about 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 18years or above Referred to endoscopy unit for diagnostic or surveillance colonoscopy Exclusion Criteria: Familial history of Familial adenomatous polyposis / Hereditary non-polyposis colorectal cancer Known history of inflammatory bowel disease Known colitis or suspicion of colitis (inflammatory bowel disease, diverticulitis, infective colitis) Emergency endoscopy of any nature (eg gastrointestinal bleeding, colonic decompression) Previous incomplete colonoscopy (not including insufficient preparation) / difficult colonoscopy Patients referred for a therapeutic procedure or assessment of a known non-resected lesion Patients with known palliative colorectal malignancy Patient with coagulopathy Patient with colostomy Patient with multiple co-morbidities (American Society of Anaesthesiologist >3) Inability to give informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kaori Futaba, FRCS
Phone
+85235051495
Email
kfutaba@surgery.cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaori Futaba
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Chinese University of Hong Kong
City
Shatin
State/Province
New Territories
Country
Hong Kong

12. IPD Sharing Statement

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ENDO-AID Assisted Tandem Colonoscopy RCT

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