Colorectal polyp
Conditions
Interventions
The intervention group (EndoBRAIN: EB group) uses EndoBRAIN-X, which is approved by the Pharmaceutical Affairs Law, and the results are referred to the physician for endoscopic diagnosis. The control
Sponsors
Misawa Masashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients 18 years of age or older scheduled for colonoscopy and consenting to the study
Exclusion criteria
Exclusion criteria: 1. patients with a history of colorectal resection (excluding appendectomy) 2. Patients who are known to have a micro-polyp that is expected to be involved in the primary endpoint before the examination, and who have specific characteristic information (location, size, morphology, pathological diagnosis, etc.) that could affect the endoscopic diagnosis of the lesion. 3. Patients with known intra-abdominal mass or intestinal mass Patients with inflammatory bowel disease, polyposis, or hereditary colorectal cancer 5. patients who cannot be treated with anticoagulants or antiplatelet agents in accordance with the Guidelines for Gastrointestinal Endoscopy for Patients on Antithrombotic Agents (2012) and Supplement (2017), and whose lesions cannot be resected 6. patients who have an emergency endoscopy (gastrointestinal bleeding, sigmoid colon torsion repair) 7. pregnant women and lactating mothers 8. Other patients who are judged by the physician in charge or the examining physician to be unsuitable for the study, including those with underlying medical conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of lesions for which pathology can be omitted | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity, specificity, positive predictive value, negative predictive value, and positive predictive value for neoplastic lesions (including SSL) of 5 mm or less (Also examine by confidence level) Sensitivity, specificity, positive predictive value, negative predictive value, and positive predictive value for neoplastic lesions less than 5 mm (not including SSL) (Also examine by confidence level) Percentage of tumor-free resections: Percentage of patients without adenoma or SSL in the resected lesion (Repici A et al. (Repici A et al. Gut 2022;71(4):757-765) Sensitivity, specificity, positive predictive value, negative predictive value, and positive predictive value for SSL in serrated lesions (also by confidence level) Agreement rates of surveillance intervals based on JGES, ASGE, and ESGE guidelines. Percentage of cases with shortened or prolonged surveillance intervals due to misdiagnosis Percentage of lesions with discrepancies between physician and AI diagnosis Endoscope removal time (time elapsed from cecum to anus including observation and treatment time) Medical costs associated with the examinations (comparison assuming that pathological diagnosis and endoscopic treatment were omitted). Learning curve of examiner's diagnostic ability Evaluation by proficiency level Sensitivity, specificity, positive diagnostic rate, negative predictive value, and positive predictive value of EB-X's diagnostic support results | — |
Contacts
Public ContactMasashi Misawa
Showa University Northern Yokohama Hospital
Outcome results
None listed