Carcinoma, Renal Cell Clinical Trial
Official title:
Three-dimensional Virtual Imaging to Improve the Accuracy of Standard CT-based Nephrometric Scores: a Prospective Multicentric Observational Study
STUDY DESIGN: prospective multicentric observational SAMPLE SIZE OF THE STUDY: The estimated number of patients to enroll in the multicenter study is at least 270 patients (statistically calculated referring to the results of a monocentric analysis including 101 patients with the same design, already performed by the Coordinator Center). NUMBER OF CENTERS INVOLVED: Considering a total number of patients enrolled of at least 270, number of Centers to be involved: 5. STUDY PROCEDURES: 3D virtual model rendering - CT-scan images sent in DICOM format to MEDICS (Turin, Italy) after anonymization. - Dedicated online platform available to upload the anonymized CT images, after registration. - CT imaging processing by bioengineers and 3DVM building within 72 hours - 3D-PDF download from the same online platform Nephrometric score assessment - All CT-scans and their 3DVMsevaluation in order to assess surgical complexity, as classified by the PADUA nephrometry score and its relative PADUA risk category. - For each Center: - assessment of the PADUA score on the basis of the CT-scans (2D-NS) by one urologist; - assessment of the PADUA score on the basis of the 3DVMs (3D-NS) by another urologist. Surgical intervention and pathological assessment - Dedicated expert surgeon for each Center performing NSS to all patients with the same surgical technique. - Dedicated uro-pathologist for each Center performing the histopathological evaluations of the specimens.
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