Comparison of Polyp Detection and False Alarm Rates in Water Exchange and Air Insufflation Colonoscopy

April 2, 2021 updated by: Chia Pei Tang, Dalin Tzu Chi General Hospital

Polyp Detection and False Alarm Rates by Computer-Aided Analysis of Videos of Withdrawal Phase of Colonoscopy in a Randomized Controlled Trial of Water Exchange Versus Air Insufflation

Water exchange (WE) improves adenoma detection rate (ADR) but missed polyps occur due to human limitations. Computer-aided detection (CADe) improves polyp detection and can overcome human omissions, but a limiting factor is feces and air bubbles related false alarms (FA). WE provides salvage cleansing and can potentially reduce FA. The investigators compared the additional polyp detection rate (APDR) and false alarm rate (FAR) by CADe between WE and air insufflation.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Worldwide colorectal cancer (CRC) is the second most common cancer in women and the third in men. Early detection and removal of the colon polyps (cancer precursors) reduce the incidence of CRC. However, interval colon cancers still occur within 3-5 years after colonoscopy among patients of colonoscopists with low adenoma detection rate (ADR), defined as the proportion of patients with at least one adenoma. ADR was widely variable, suggesting that some adenomas were missed. Twenty six percent of adenomas were missed during tandem examination reported in a recent meta-analysis. Missed adenomas accounted for about 58% of interval cancers. Adenomas are more likely to be missed in the right colon than in other segments because of their flat morphology and hiding behind the accentuated folds and curvatures. Innovations in colonoscopy to increase ADR and decrease adenoma miss rate (AMR) hold the potential to reduce interval cancers.

The consensus statements in a recent modified Delphi review confirmed water exchange (WE) as a standardized insertion method produced less insertion pain, better bowel cleanliness and higher ADR than gas insufflation. It is characterized by infusing water to guide insertion in an airless lumen and almost simultaneous suctioning of the infused water during insertion, aiming at near-complete removal of the infused water and debris upon cecal intubation. Although an RCT with tandem examination showed WE significantly decreased right colon adenoma miss rate (rAMR) compared with CO2 insufflation (18.0% [33/183] vs. 34.6% [62/179], P = 0.0025), a considerable percentage of polyps in the right colon were still overlooked.

In recent years, the field of machine learning and artificial intelligence has made remarkable progress, and an increasing number of publications showed improved polyp detection rate (PDR) and ADR using computer-aided detection (CADe). CADe can detect polyps overlooked by the colonoscopist due to human limitations of inattention or inexperience. However, one major drawback of current CADe systems is false alarms (FAs), or false positives (FPs). Usually triggered by bubbles and fecal debris, FAs might distract the endoscopists with potential unfavorable effect on ADR. One study reported a FP rate of up to 60%.

In an overview on applying deep learning algorithms and WE in colonoscopy to improve adenoma detection, the authors noted that WE could enhance the performance of artificial intelligence (CADe) by improving bowel cleanliness and thus the exposure of polyps. In a follow-up review, the authors reported that artificial intelligence might mitigate operator-dependent factors that limited the potential of WE, while WE might provide the platform to optimize the performance of artificial intelligence by increasing bowel cleanliness and improving visualization, Therefore, the strengths of WE and artificial intelligence may complement the weaknesses of each other to maximize adenoma detection.

One of our recently completed studies compared right colon ADR evaluated by a blinded endoscopist using either air insufflation or WE for insertion, with all the colonoscopies video recorded (NCT02737514). We developed and applied a CADe system to detect the polyps in the videos. The current report is a proof of principle study to test the hypothesis that WE could yield a significantly higher additional PDR (APDR) and reduce false alarms rate (FAR) as compared to air insufflation in the right colon.

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Chiayi
      • Chiayi City, Chiayi, Taiwan, 62247
        • Chia Pei Tang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients were undergoing screen, diagnostic or surveillance colonoscopy were enrolled.

Description

Inclusion Criteria:

  • Patients aged 40 to 80 years old, undergoing screen, diagnostic or surveillance colonoscopy were enrolled.

Exclusion Criteria:

  • Patients were excluded in case of having colonoscopy in the past 3 years, renal failure, previous colonic resection, scheduled for polypectomy, partial intake of bowel preparation, American Society of Anesthesiology (ASA) Risk Class 3 or higher, and lack of written informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Water exchange with computer-aided detection system
Computer-aided detection system overlaid videos with water exchange colonoscopy method
Other: Computer-aided detection system overlaid colonoscopy videos analysis
Analysis of computer-aided detection system overlaid videos from colonoscopies performed with water exchange or air insufflation method.
Air insufflation with computer-aided detection system
Computer-aided detection system overlaid videos with air insufflation colonoscopy method
Other: Computer-aided detection system overlaid colonoscopy videos analysis
Analysis of computer-aided detection system overlaid videos from colonoscopies performed with water exchange or air insufflation method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Polyp detection rate
Time Frame: One month
To find out and compare the polyp detection rate on water exchange and air insufflation group
One month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
False positive rate of computer-aided detection system
Time Frame: One month
To find out and compare the false positive rates on water exchange and air insufflation group
One month
False alarm rate of computer-aided detection system
Time Frame: One month
To find out and compare the false alarm rates on water exchange and air
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dalin Tzu Chi General Hospital

Collaborators

University of California
National Chiayi University

Investigators

  • Principal Investigator: Chia Pei Tang, Dalin Tzu Chi General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2020

Primary Completion (ACTUAL)

September 1, 2020

Study Completion (ANTICIPATED)

April 10, 2021

Study Registration Dates

First Submitted

January 18, 2021

First Submitted That Met QC Criteria

January 24, 2021

First Posted (ACTUAL)

January 27, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 5, 2021

Last Update Submitted That Met QC Criteria

April 2, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B10903009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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