Clinical trial NCT05729763: Three-dimensional Virtual Imaging to Improve the Accuracy of Standard CT-based Nephrometric Scores: a Prospective Multicentric Observational Study
Official title: Three-dimensional Virtual Imaging to Improve the Accuracy of Standard CT-based Nephrometric Scores: a Prospective Multicentric Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Neoplasms
Carcinoma, Renal Cell
Keywords: minimally-invasive partial nephrectomy
nephrometry scores
3D virtual imaging
HA3D
postoperative complications
Lead sponsor: San Luigi Gonzaga Hospital
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with localized renal tumor scheduled for partial nephrectomy

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.


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.

Primary outcomes:
measure: PADUA nephrometry score calculated via 3D virtual modelling and standard bidimensional CT scan images
timeFrame: Baseline
Secondary outcomes:
measure: To compare the occurrence of postoperative complications, assessed by Clavien-Dindo classification
timeFrame: 90 days after surgery
Other outcomes:
Locations:
city: Orbassano
country: Italy
facility: San Luigi Gonzaga Hospital
state: TO
Study officials:
References: