Three-dimensional Virtual Imaging to Improve the Accuracy of Standard CT-based Nephrometric Scores: a Prospective Multicentric Observational Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Kidney Neoplasms
- Sponsor
- San Luigi Gonzaga Hospital
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- PADUA nephrometry score calculated via 3D virtual modelling and standard bidimensional CT scan images
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
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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.
Investigators
Francesco Porpiglia
Prof.
San Luigi Gonzaga Hospital
Eligibility Criteria
Inclusion Criteria
- •four-phase (unenhanced, corticomedullary, nephrographic and urographic phases) contrast enhanced CT-scan
Exclusion Criteria
- •evidence of anatomical abnormalities, like horse-shoe shaped or ectopic kidney.
- •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.
Outcomes
Primary Outcomes
PADUA nephrometry score calculated via 3D virtual modelling and standard bidimensional CT scan images
Time Frame: Baseline
The PADUA nephrometry score predicts the risk of surgical and medical perioperative complications in patients who underwent partial nephrectomy. The PADUA nephrometry score evaluates different tumor characteristics: * Longitudinal (polar) location (Superior/inferior: 1pt; Middle: 2 pt), * Exophytic rate (\>=50%: 1pt; \<50%: 2pt; Endophytic: 3pt) * Renal rim (Lateral: 1pt; Medial: 2pt) * Renal sinus (Not involved: 1pt; Involved: 2pt) * Urinary collecting system (Not involved: 1pt; Dislocated/infiltrated: 2pt) * Tumor size (\<=4 cm: 1pt; 4.1-7 cm: 2pt; \>7: 3pt) The PADUA score, calculated as the sum of these parameters, stratify patients from PADUA 6 tumors, that have low risk of complications, to PADUA 14, with high risk of perioperative complications.
Secondary Outcomes
- To compare the occurrence of postoperative complications, assessed by Clavien-Dindo classification(90 days after surgery)