Computer Aided Diagnosis of Colorectal Polyps (EndoBrain)

Real-Time Artificial Intelligence Aided Diagnosis of Colorectal Polyps During Colonoscopy: A Clinical Trial With the EndoBRAIN Technology

The purpose of this study is to assess whether computer aided technology (CAD) can help in the diagnosis of polyps found the bowel compared with visual inspection alone and therefore whether it is beneficial in helping clinicians to decide whether to remove a polyp or not. Presently, most endoscopists remove all polyps found and send them to the laboratory for testing. The number of colonoscopies is increasing, meaning that more polyps are detected and removed. This comes at a significant cost to the health service and increases the time taken to complete a colonoscopy.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Colonic Polyp
• Intervention / Treatment: Diagnostic test: Endobrain, Computer Aided Diagnosis (CAD)

Detailed Description

Removing precancerous polyps from the bowel during a colonoscopy (camera test) is the cornerstone of colorectal cancer screening and prevents polyps developing into bowel cancer. Most polyps develop in the rectosigmoid colon (lower part of the bowel). Many polyps never grow into cancer and it can be difficult for the clinicians performing the procedure (endoscopists) to tell which ones are precancerous. This means many polyps are removed unnecessarily, with a considerable waste of resources.

A recent preliminary study indicates a novel artificial intelligence system (EndoBRAIN) for computer-aided diagnosis may be able to distinguish different types of polyps during colonoscopy and therefore help doctors decide which polyps to remove. This study aims to compare the in accuracy of artificial intelligence against the endoscopist's assessment for diagnosis of diminutive (<5mm) polyps in the lower colon.

Patients who are age 18 years or older who undergo colonoscopy for any indication at the participating clinical centres and are diagnosed with diminutive rectosigmoid polyps are eligible for study enrolment. For each detected polyp in the rectosigmoid colon, endoscopists will assess the polyp type using standard colonoscopies (cameras) and then with the use of the EndoBRAIN technology.

The polyps will be removed and sent to the laboratory for testing. The difference between clinician diagnosis and EndoBRAIN diagnosis will be compared with the laboratory findings. We hypothesize that the EndoBRAIN technology provides a superior accuracy in identifying precancerous rectosigmoid polyps, compared to endoscopist's own prediction with a standard colonoscope.

If the trial confirms the superior accuracy of the EndoBRAIN system, polyps classified as non-cancerous with the EndoBRAIN system no longer need to be removed, meaning a large gain for patients and society, due to significantly less polypectomies and pathology reviews.

• Study Type: Observational
• Enrollment (Actual): 89

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 9RS
    • King's College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any patient 18 years or older scheduled for screening, surveillance, diagnostic, or therapeutic colonoscopy at King's College Hospital with diminutive rectosigmoid polyps.

Description

Inclusion Criteria:

• Individuals 18 years or older who are scheduled for screening, surveillance, diagnostic, or therapeutic colonoscopy at at King's College Hospital with diminutive rectosigmoid polyps.

Exclusion Criteria:

• Diminutive polyps with known histology
• Inflammatory bowel disease
• Polyposis syndrome (e.g., familial adenomatous polyposis, serrated polyposis)
• History of chemotherapy or radiation therapy for colorectal lesions
• Inability to undergo polypectomy (e.g. intake of anticoagulants, comorbidities, or patient refusal)
• Pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment Group; All patients will undergo CAD of any diminutive polyps found in the rectosigmoid on colonoscopy	Diagnostic test: Endobrain, Computer Aided Diagnosis (CAD); Artificial intelligence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
True positive adenoma detection rate	True positive adenoma detection rate with visual inspection versus true positive adenoma detection rate with visual inspection plus CAD	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
True negative adenoma detection rate	True negative adenoma detection rate with visual inspection versus true negative adenoma detection rate with visual inspection plus CAD	6 months
To estimate the sensitivity, specificity, of visual inspection and the use of the EndoBRAIN CAD technology	To estimate the sensitivity, specificity, of visual inspection and the use of the EndoBRAIN CAD technology	6 months
To estimate the positive predictive value [PPV], and NPV of the combination of visual inspection and the use of the EndoBRAIN CAD technology	To estimate the positive predictive value [PPV], and NPV of the combination of visual inspection and the use of the EndoBRAIN CAD technology	6 months
To estimate the percentage of diminutive colorectal polyps from which endocytoscopic images can be successfully captured (acquisition rate).	To estimate the percentage of diminutive colorectal polyps from which endocytoscopic images can be successfully captured (acquisition rate).	6 months
To estimate the rate of high-confidence diagnosis with EndoBRAIN as compared to visual polyp inspection alone.	To estimate the rate of high-confidence diagnosis with EndoBRAIN as compared to visual polyp inspection alone.	6 months
Time of colonoscopy	Time of colonoscopy to be recorded.	during procedure
Complications	complications to be recorded.	6 months

Collaborators and Investigators

• Sponsor: King's College Hospital NHS Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2020
• Primary Completion (ACTUAL): May 5, 2021
• Study Completion (ACTUAL): May 5, 2021

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: August 11, 2020
• First Posted (ACTUAL): August 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2022
• Last Update Submitted That Met QC Criteria: January 17, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Intestinal Polyps; Polyps; Colonic Polyps
• Other Study ID Numbers: 260047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The IPD will be kept within the research team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No