Completed

NCT Number: NCT05729763

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.

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Key information

Conditions

Kidney Neoplasms Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

San Luigi Gonzaga Hospital

Orbassano, TO, 10048, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3D-PADUA nephrometric score

Other

Evaluation of the PADUA nephrometric score with 3D images

2D-PADUA nephrometric score

Other

Evaluation of the PADUA nephrometric score with 2D images

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

San Luigi Gonzaga Hospital

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2022
First posted: Feb 15, 2023
Registry last updated: Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed