Adenoma Detection Rate in Water and Air Colonoscopy Using Computer-aided System

Adenoma Detection Using Real-Time Computer-Aided Colon Polyp Detection System to Compare Water Exchange and Air Insufflation - A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Colonoscopy; Colon Adenoma
• Intervention / Treatment: Device: Colonoscopy with water exchange or air insufflation methods

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.

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chia Pei Tang, MD; Phone Number: 0921128335; Email: franktg@hotmail.com

Study Locations

• Taiwan
  • Chiayi County
    • Chiayi City, Chiayi County, Taiwan, 62247
      • Recruiting
      • Chia Pei Tang
      • Contact: Chia P Tang, MD; Phone Number: 0921128335; Email: franktg@hotmail.com
• United States
  • California
    • Los Angeles, California, United States, 91343
      • Active, not recruiting
      • Sepulveda Ambulatory Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Water exchange; This group of participants receives water exchange colonoscopy with the computer-aided polyp detection system.	Device: Colonoscopy with water exchange or air insufflation methods; 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.
ACTIVE_COMPARATOR: Air insufflation; This group of participants receives air insufflation colonoscopy the computer-aided polyp detection system.	Device: Colonoscopy with water exchange or air insufflation methods; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adenoma detection rate	proportion of patients with at least one colorectal adenoma detected among all patients examined by an endoscopist	During each colonoscopy procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
false positive rate	number of false positive appears using the computer-aided polyp detection system in all participants	During each colonoscopy procedure

Collaborators and Investigators

• Sponsor: Dalin Tzu Chi General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 16, 2022
• Primary Completion (ANTICIPATED): May 15, 2023
• Study Completion (ANTICIPATED): May 15, 2023

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: July 3, 2022
• First Posted (ACTUAL): July 7, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 8, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: adenoma detection rate, computer-aided system
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: A11004002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No