Adenoma Detection Rate in Water and Air Colonoscopy Using Computer-aided System
Primary Purpose
Colon Adenoma, Colonoscopy
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Colonoscopy with water exchange or air insufflation methods
Sponsored by
About this trial
This is an interventional diagnostic trial for Colon Adenoma focused on measuring adenoma detection rate, computer-aided system
Eligibility Criteria
Inclusion Criteria:
- Consecutive patients, undergoing screen, diagnostic or surveillance colonoscopy performed by the participating endoscopists will be enrolled.
Exclusion Criteria:
- We excluded patients age < 50 or > 80 years old, undergone colonoscopy in the past 3 years, partial intake of bowel preparation, renal failure, previous colonic resection, scheduled for polypectomy, American Society of Anesthesiology (ASA) Risk Class 3 or higher, and lack of written informed consent.
Sites / Locations
- Sepulveda Ambulatory Care Center
- Chia Pei TangRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Water exchange
Air insufflation
Arm Description
This group of participants receives water exchange colonoscopy with the computer-aided polyp detection system.
This group of participants receives air insufflation colonoscopy the computer-aided polyp detection system.
Outcomes
Primary Outcome Measures
adenoma detection rate
proportion of patients with at least one colorectal adenoma detected among all patients examined by an endoscopist
Secondary Outcome Measures
false positive rate
number of false positive appears using the computer-aided polyp detection system in all participants
Full Information
NCT ID
NCT05448300
First Posted
June 21, 2022
Last Updated
July 8, 2022
Sponsor
Dalin Tzu Chi General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05448300
Brief Title
Adenoma Detection Rate in Water and Air Colonoscopy Using Computer-aided System
Official Title
Adenoma Detection Using Real-Time Computer-Aided Colon Polyp Detection System to Compare Water Exchange and Air Insufflation - A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 16, 2022 (Actual)
Primary Completion Date
May 15, 2023 (Anticipated)
Study Completion Date
May 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dalin Tzu Chi General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Water exchange (WE) is an effective insertion method to minimize insertion discomfort and maximize ADR. It is characterized by infusing water to guide insertion in an airless lumen with suctioning of infused water during insertion and almost complete removal of the infused water when cecal intubation is achieved. A modified Delphi review reported water exchange showed the highest overall ADR, ADR in screening cases, and in the right side of the colon compared with water immersion and air (or CO2) insufflation. One of the plausible mechanisms of improving ADR by water exchange is salvage cleaning during insertion, which might help artificial intelligence by removing the interference of fecal debris and bubbles. However, no RCT has been performed to evaluate the effect of CADe on WE colonoscopy.
Therefore, investigators will conduct a RCT comparing the ADR of CADe assisted colonoscopy inserted with either WE or insufflation. Our hypothesis will be that CADe assisted WE colonoscopy achieves higher ADR than CADe assisted air insufflation colonoscopy.
Detailed Description
The primary end point will be ADR, defined as the proportion of patients with at least one adenoma. Serrated lesions will not be counted as part of ADR. Secondary outcomes were FP rate, adenomas per colonoscopy (APC), polyp detection rate, polyps per colonoscopy, SL detection rate, cecal intubation rate, withdrawal time. Missed polyp will be defined as a polyp recognized by endoscopist, but is not detected by CADe system at an interval of 2 seconds. The detected polyps will be classified in sizes, morphology (polypoid or nonpolypoid). Investigators also record the detection of every polyp by the endoscopist or the CADe system in time priority. If a polyp is detected by performing endoscopist at the same time as the CADe system, the credit will go to the endoscopist. The colonoscopy procedure will be recorded as CADe over-laid videos and be reviewed for FP characteristics, numbers and appearance time afterward. The withdrawal time will be divided into inspection time, cleaning time and polypectomy time. Boston Bowel Preparation Scale score and the amount of water infused and aspirated will also be recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Adenoma, Colonoscopy
Keywords
adenoma detection rate, computer-aided system
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
Participant
Masking Description
In two groups with blinding
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Water exchange
Arm Type
Active Comparator
Arm Description
This group of participants receives water exchange colonoscopy with the computer-aided polyp detection system.
Arm Title
Air insufflation
Arm Type
Active Comparator
Arm Description
This group of participants receives air insufflation colonoscopy the computer-aided polyp detection system.
Intervention Type
Device
Intervention Name(s)
Colonoscopy with water exchange or air insufflation methods
Intervention Description
Using computer-aided polyp detection algorithm on colonoscopy with water exchange or air insufflation methods. This computer-aided algorithm does not intervene directly the colonoscopy procedure.
Primary Outcome Measure Information:
Title
adenoma detection rate
Description
proportion of patients with at least one colorectal adenoma detected among all patients examined by an endoscopist
Time Frame
During each colonoscopy procedure
Secondary Outcome Measure Information:
Title
false positive rate
Description
number of false positive appears using the computer-aided polyp detection system in all participants
Time Frame
During each colonoscopy procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Consecutive patients, undergoing screen, diagnostic or surveillance colonoscopy performed by the participating endoscopists will be enrolled.
Exclusion Criteria:
We excluded patients age < 50 or > 80 years old, undergone colonoscopy in the past 3 years, partial intake of bowel preparation, renal failure, previous colonic resection, scheduled for polypectomy, American Society of Anesthesiology (ASA) Risk Class 3 or higher, and lack of written informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chia Pei Tang, MD
Phone
0921128335
Email
franktg@hotmail.com
Facility Information:
Facility Name
Sepulveda Ambulatory Care Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
91343
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Chia Pei Tang
City
Chiayi City
State/Province
Chiayi County
ZIP/Postal Code
62247
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chia P Tang, MD
Phone
0921128335
Email
franktg@hotmail.com
12. IPD Sharing Statement
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Adenoma Detection Rate in Water and Air Colonoscopy Using Computer-aided System
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