Clinical trial NCT03925337: Computer Aided Detection of Polyps in the Colon
Official title: Computer Aided Detection of Polyps in the Colon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polyp, Adenomatous
Colo-rectal Cancer
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 234
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, the colonoscopist will carefully inspect segments of colon during advancement and then again on withdrawal of the colonoscope. Those who qualify will be randomized into two arms, as detailed in the bullets below: scope Insertion will be the same for both arms, without the aid of the research software. Below are two groups that qualifying subjects will be randomized into:

* Group of patients in Arm-1- recruited patients will receive Standard Colonoscopy followed by AI-Assisted Combined Colonoscopy
* Group of patients in Arm-2- recruited patients will received AI-Assisted Combined Colonoscopy followed by Standard Colonoscopy
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to examine the role of an automatic polyp detection software (henceforth referred to as the research software) as a support system during colonoscopy; a procedure during which a physician uses a colonoscope or scope, to look inside a patient's rectum and colon. The scope is a flexible tube with a camera-to see the lining of the colon. The research software is used to aid in the detection of polyps (abnormal tissue growths in the wall of the colon and adenomas (pre-cancerous growths) during colonoscopy.

The research software used in this study was programmed by a company in Shanghai, which develops artificial intelligence software for computer aided diagnostics.

The research software was developed using a large repository (database or databases) of polyp images where expert colonoscopists outlined polyps and suspicious lesions. The software was subsequently developed and validated using several databases of images and video to operate in near real-time or within minutes of photographing the tissue. It is intended to point out polyps and suspicious lesions on a separate screen that stands behind the primary monitor during colonoscopy. It is not expected to change the colonoscopy procedure in any way, and the physician will make the final determination on whether or not to biopsy or remove any lesion in the colon wall.

The research software will not record any video data during the colonoscopy procedure. In the future, this software may help gastroenterologists detect precancerous areas and decrease the incidence of colon cancer in the United States.

Detailed description: Length of Study - The duration of the study is expected to be 8-12 months. Enrollment of study patients will cease when approximately 250 patients have been enrolled.

Study Design- Design will be a multi-center, prospective, unblinded randomized control trial. Patients referred for either screening or surveillance colonoscopy will be included.

Equipment: Aside from standard of care scope used, a second computer monitor that will stand behind the standard monitor used during colonoscopy. Additionally , a computer system unit with an operating system.

Standard Clinical Procedure Typically, intravenous sedation using a combination of benzodiazepine and narcotic medications (with or without propofol under the supervision of a trained anesthesiologist) are used for colonoscopy. Continuous pulse oximetry and blood pressure monitoring is used throughout the procedure. Supplemental oxygen is used as needed. Patients are usually placed in the left lateral decubitus position and the colonoscope is introduced into the rectum. The colonoscope is advanced under direct visualization until the cecum and appendiceal orifice is reached. The colonoscope is usually retroflexed within the rectum. The colonoscopist carefully inspects each segment of colon during advancement and then again on withdrawal of the colonoscope. Any suspicious lesions encountered during insertion or withdrawal are inspected by the colonoscopist and a final determination is made by the clinician on whether or not to remove a given lesion. Any lesion that is deemed suspicious or polypoid is removed by en-bloc polypectomy, piecemeal polypectomy, or may be referred for endoscopic mucosal resection (EMR) at a later date. After the procedure, patients recover in the post-procedural recovery room. After the procedure, results are discussed with the patient. The ability of colonoscopy to detect lesions is discussed with the patient as well as the fact that a small percentage of polyps and other lesions may be missed during the test.

Study Procedure Patients will receive a colonoscopy with a gastroenterologist. During the standard clinical procedural protocol and for the study period, colonoscopists will have the benefit of a second monitor that will project the polyp detection algorithm in real-time over the video output of the colonoscopy. The algorithm will detect suspicious, polyp-like lesions within the lumen of the colon, and during the procedure a research assistant will view the second monitor at all times and record a time stamp for any potential polyps on an intra-procedural data collection sheet.

Data Collection Variables collected and measured will include colonoscopist(s) performing the procedure, number of adenomas noted per procedure, adenoma detection rate for a given colonoscopist, number of polyps detected per procedure, polyp detection rate (the proportion of colonoscopic examinations performed that detect one or more polyps), cecal intubation rate, time needed to reach the cecum, time needed to withdraw colonoscope both when polyps are identified (and thus need to be removed) and on normal colonoscopy, level of sedation, and complications: Acute if within 48 hours of procedure \& delayed if within 3-30 days after procedure.

Data Analysis - Normally distributed continuous variables will be summarized using means and standard deviations while non-normally distributed continuous variables will be summarized using medians and ranges.

Eligibility criteria: Inclusion Criteria:

* Patients age: ≥ 22 years
* Patients presenting for routine colonoscopy for screening and/or surveillance purposes.
* Willingness to undergo two withdrawals with and without the use of computer-aided software while undergoing conventional colonoscopy with sedation
* Ability to provide written, informed consent and understand the responsibilities of trial participation

Exclusion Criteria:

* Minors aged \< 22 years.
* People with diminished cognitive capacity
* Patients undergoing diagnostic colonoscopy (e.g. as an evaluation for active gastrointestinal bleed, referring collectively to the stomach and the small and large intestine).
* Patients with incomplete colonoscopies (those where endoscopists did not successfully intubate the cecum due to technical difficulties or poor bowel preparation)
* Patients that have standard contraindications to colonoscopy in general (e.g. documented acute diverticulitis, fulminant colitis and known or suspected perforation).
* Patients with inflammatory bowel disease
* Patients with any polypoid/ulcerated lesion \> 2 cm concerning for invasive cancer on endoscopy
* Patients referred for endoscopic mucosal resection (EMR), which is a procedure to remove early-stage cancer and precancerous growths from the lining of the digestive tract.

Primary outcomes:
measure: Adenoma Miss Rate (AMR)
timeFrame: One Hour
Secondary outcomes:
measure: Polyp Miss Rate (PMR)
timeFrame: One Hour
measure: Amplified adenoma detection rate
timeFrame: 6 months
measure: Advanced adenoma miss rate determination
timeFrame: 6 months
measure: Colonoscope segmental withdrawal time determination
timeFrame: 6-10 minutes
measure: Total procedure time determination
timeFrame: During length of procedure
measure: Rate of adverse event determination
timeFrame: 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: New York
country: United States
facility: NYU Langone
state: New York
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Tyler M Berzin, MD
role: PRINCIPAL_INVESTIGATOR
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