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.

Study Overview

• Status: Completed
• Conditions: Kidney Neoplasms; Carcinoma, Renal Cell
• Intervention / Treatment: Other: 3D-PADUA nephrometric score; Other: 2D-PADUA nephrometric score

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Italy
  • TO
    • Orbassano, TO, Italy, 10048
      • San Luigi Gonzaga Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with localized renal tumor scheduled for partial nephrectomy

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PADUA nephrometry score calculated via 3D virtual modelling and standard bidimensional CT scan images	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.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the occurrence of postoperative complications, assessed by Clavien-Dindo classification	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.	90 days after surgery

Collaborators and Investigators

• Sponsor: San Luigi Gonzaga Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: January 23, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: postoperative complications; minimally-invasive partial nephrectomy; nephrometry scores; 3D virtual imaging; HA3D
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell
• Other Study ID Numbers: 8193 02 06 - 07 Jun 2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No