Three-dimensional Virtual Imaging to Improve the Accuracy of Standard CT-based Nephrometric Scores: a Prospective Multicentric Observational Study

Sponsor

San Luigi Gonzaga Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05729763

Collaborator

(none)

300

Enrollment

Location

Actual Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Neoplasms Carcinoma, Renal Cell	Other: 3D-PADUA nephrometric score Other: 2D-PADUA nephrometric score

Study Design

Study Type:

Observational

Actual Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Three-dimensional Virtual Imaging to Improve the Accuracy of Standard CT-based Nephrometric Scores: a Prospective Multicentric Observational Study

Actual Study Start Date :

Jun 1, 2019

Actual Primary Completion Date :

Sep 30, 2022

Actual Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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	Other: 3D-PADUA nephrometric score Evaluation of the PADUA nephrometric score with 3D images Other: 2D-PADUA nephrometric score Evaluation of the PADUA nephrometric score with 2D images

Arm

Intervention/Treatment

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

Other: 3D-PADUA nephrometric score

Evaluation of the PADUA nephrometric score with 3D images

Other: 2D-PADUA nephrometric score

Evaluation of the PADUA nephrometric score with 2D images

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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