colorectal tumor and cancer
Conditions
Interventions
None listed
Sponsors
Showa University Northern Yokohama Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Case of over 18 years old at the time of endoscopic examination 2.Case in which pathological diagnosis is possible by biopsy, endoscopic or surgical resection for colon lesions. 3.Cases with normal judgment ability and can express intention
Exclusion criteria
Exclusion criteria: 1.In cases where histological evaluation is impossible (biopsy, pathological evaluation of excised specimens not yet performed). 2.Cases in which pretreatment such as anticancer drug therapy, radiotherapy etc is done. 3.The patient made an offer to refuse to use data with opt-out. 4.A case with inflammatory bowel disease. 5.In addition, cases in which clinical researcher or clinical research sharing doctor judged inappropriate as subject of this examination. .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This trial will be triple primary endpoint clinical trial. 1.When EC-CAD was used under methylene blue staining for polyps of 5 mm or less in diameter in the sigmoid colon from the rectum, it was verified that the result diagnosed with high confidence (probability 90% or more) was NPV 90% or more. 2.When observing a polyp of 5 mm or less in diameter with magnifying narrow band imaging (NBI) and NBI combined endocytoscopy (EC-NBI), verify that the ratio at which trainee can acquire a focused endoscope video for 3 seconds or more at EC-NBI. 3.When EC-CAD is used under methylene blue staining for colon lesions of 20 mm or more in diameter, we verify that the diagnostic ability for invasive cancer is over 90% PPV. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Diagnostic accuracy of diminitive polyps in EC-CAD and diagnostic accuracy at high confidence in sigmoid colon and rectum. 2.Diagnostic accuracy of diminitive polyps in EC-NBI-CAD and diagnostic accuracy at high confidence in sigmoid colon or rectum. 3.Percentage of methylene blue staining or EC-CAD-NBI succesfuly performed for diminitive polyps less than 5 mm. 4.Diagnostic performance of EC-CAD for polyps whose diameters are 6-9mm or 10mm- 5.Discussion on differences between experts and trainees in each secondary outcome from 1 to 3. 6.Percentage of cases experts can acquire images that were in focus using EC-NBI and NBI for more than 3 seconds. 7.Percentage of cases where experts and trainees can acquire one or more EC-NBI and magnifying NBI images. 8.Percentage of cases where experts and trainees can obtain an in-focus image for 3 seconds or more with diminitive polyps of 5 mm or less and other polyps. 9.Percentage by localization of lesions when experts and trainees can acquire an in-focus image for more than 3 seconds. 10.The difference of the longest time that it was possible to maintain the focused state with EC-NBI and magnifying NBI image. 11.Sensitivity, specificity, correct diagnostic rate, PPV, NPV for invasive cancer when expert and trainee use EC - CAD for colon neoplastic lesions of 20 mm or more. 12.Examination of the cause of EC-CAD diagnostic results becoming low confidence or not a good sample when experts and trainees use EC-CAD. 13.Comparison of the difference in time taken by experts and trainees to acquire 10 EC images after acquiring first EC image. 14.Verification of the influence of depth of tumor on diagnostic results using EC-CAD. 15.Comparison of the difference depending on the depth of tumor invasion when evaluating vessel diameter and caliber change using CAD for EC-NBI. | — |
Countries
Japan
Contacts
Public ContactKenichi Takeda
Showa University Northern Yokohama Hospital Digestive Disease Center
Outcome results
None listed