Diminutive rectosigmoid polyps
Conditions
Interventions
Diagnosis using EndoBRAIN. (The present study does not require additional invasive interventions as compared to clinical practice. )
Sponsors
Oslo University; Showa University; King's college
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Individuals 18 years or older who are scheduled for screening, surveillance, diagnostic, or therapeutic colonoscopy at the trial centres with diminutive rectosigmoid polyps (<=5mm).
Exclusion criteria
Exclusion criteria: 1. Diminutive polyps with known histology 2. Inflammatory bowel disease 3. Polyposis syndrome (e.g., familial adenomatous polyposis, serrated polyposis) 4. History of chemotherapy or radiation therapy for colorectal lesions 5. Inability to undergo polypectomy (e.g. intake of anticoagulants, comorbidities, or patient refusal) 6. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the sensitivity of identifying diminutive colorectal polyps as adenomas during colonoscopy with the combination of visual inspection and the use of the EndoBRAIN technology to visual inspection alone. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the specificity of identifying diminutive colorectal polyps as adenomas during colonoscopy with the combination of visual inspection and the use of the EndoBRAIN CAD technology to visual inspection alone. 2. To estimate the sensitivity, specificity, positive predictive value, and negative predictive value of the combination of visual inspection and the use of the EndoBRAIN CAD technology 3. To assess whether the diagnostic performance of the combination of visual inspection and the use of the EndoBRAIN CAD technology of endoscopists meets the PIVI-1 and PIVI-2 guideline recommendations for diagnostic performance of the American Society of Gastrointestinal Endoscopy (ASGE)12: >90% accuracy in predicting post-polypectomy surveillance intervals based on optical biopsy with high confidence (PIVI-1*); >90% NPV in identifying rectosigmoid diminutive adenomas based on optical biopsy with high confidence (PIVI-2)6. 4. To estimate the percentage of diminutive colorectal polyps from which endocytoscopic images can be successfully captured (acquisition rate). 5. To estimate the rate of high-confidence diagnosis with EndoBRAIN as compared to visual polyp inspection alone. 6. To evaluate the colonoscopy performance with an endocytoscope including the EndoBRAIN device with regard to cecal intubation rate, insertion time, and complications. | — |
Countries
Japan,Europe
Contacts
Public ContactYuichi Mori
Showa University Northern Yokohama Hospital, Yokohama Digestive Disease Center
Outcome results
None listed