Computer Aided Diagnosis of Colorectal Polyps

Colorectal Cancer Clinical Trial

— EndoBrain  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04510545
• Other study ID #: 260047
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: May 5, 2021

Study information

• Verified date: January 2022
• Source: King's College Hospital NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: May 5, 2021
• Est. primary completion date: May 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonic Polyp
• Colonic Polyps
• Colorectal Cancer
• Polyps

Intervention

Diagnostic Test:
• Endobrain, Computer Aided Diagnosis (CAD)
Artificial intelligence

Locations

Country	Name	City	State
United Kingdom	King's College Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time of colonoscopy	Time of colonoscopy to be recorded.	during procedure
Secondary	Complications	complications to be recorded.	6 months