Carcinoma, Renal Cell, Kidney Neoplasms
Conditions
Keywords
minimally-invasive partial nephrectomy, nephrometry scores, 3D virtual imaging, HA3D, postoperative complications
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. * 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.
Interventions
OTHER3D-PADUA nephrometric score
Evaluation of the PADUA nephrometric score with 3D images
OTHER2D-PADUA nephrometric score
Evaluation of the PADUA nephrometric score with 2D images
Sponsors
San Luigi Gonzaga Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PADUA nephrometry score calculated via 3D virtual modelling and standard bidimensional CT scan images | 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
| Measure | Time frame | Description |
|---|---|---|
| To compare the occurrence of postoperative complications, assessed by Clavien-Dindo classification | 90 days after surgery | The Clavien-Dindo classification evaluates severity of complications in 5 groups: * Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions; * Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications; * Grade III: Requiring surgical, endoscopic or radiological intervention (IIIa: Intervention not under general anesthesia; IIIb: Intervention under general anesthesia); * Grade IV Life-threatening complication requiring IC/ICU-management (IVa: single organ dysfunction; IVb: multiorgan dysfunction); * Grade V: Death of a patient. |
Countries
Italy
Outcome results
None listed