Clinical trial NCT04727814: Comparison of Polyp Detection and False Alarm Rates in Water Exchange and Air Insufflation Colonoscopy
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colon Polyp
Keywords: water exchange, polyp detection rate
Lead sponsor: Dalin Tzu Chi General Hospital
Sponsor class: OTHER
Collaborators: name: University of California
name: National Chiayi University
First posted: 2021-01-27
Enrollment: 250
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients were undergoing screen, diagnostic or surveillance colonoscopy were enrolled.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Polyp detection rate
timeFrame: One month
Secondary outcomes:
measure: False positive rate of computer-aided detection system
timeFrame: One month
measure: False alarm rate of computer-aided detection system
timeFrame: One month
Other outcomes:
Locations:
city: Chiayi City
country: Taiwan
facility: Chia Pei Tang
state: Chiayi
Study officials:
affiliation: Dalin Tzu Chi General Hospital
name: Chia Pei Tang
role: PRINCIPAL_INVESTIGATOR
References:
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