Three-dimensional Virtual Imaging to Improve the Accuracy of Standard CT-based Nephrometric Scores: a Prospective Multicentric Observational Study
NCT ID: NCT05729763
Last Updated: 2023-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
300 participants
OBSERVATIONAL
2019-06-01
2022-09-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with localized renal tumor
Patients with localized renal tumor scheduled for minimally invasive partial nephrectomy in which 2D- and 3D-PADUA nephrometric score assessment was performed preoperatively
3D-PADUA nephrometric score
Evaluation of the PADUA nephrometric score with 3D images
2D-PADUA nephrometric score
Evaluation of the PADUA nephrometric score with 2D images
Interventions
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3D-PADUA nephrometric score
Evaluation of the PADUA nephrometric score with 3D images
2D-PADUA nephrometric score
Evaluation of the PADUA nephrometric score with 2D images
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* preoperative imaging inadequate to perform a 3DVM (such as those with a CT-scan with \>3 mm acquisition interval of the slices, or suboptimal difference of enhancement among the enhanced phases) or older than 3 months.
18 Years
ALL
No
Sponsors
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San Luigi Gonzaga Hospital
OTHER
Responsible Party
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Francesco Porpiglia
Prof.
Locations
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San Luigi Gonzaga Hospital
Orbassano, TO, Italy
Countries
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Other Identifiers
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8193 02 06 - 07 Jun 2019
Identifier Type: -
Identifier Source: org_study_id
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