3D-biomodels for Surgical Planning in Patients With Renal Cancer and Vascular Involvement

NCT03738488 | Unknown

• 1 other identifier: Trials 3D Urologia
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

Objectives: Apply 3D- printed biomodels in patients with renal cancer (RCa) and vascular involvement (VTT) to: (1) improve surgical planning, (2) upgrade surgical results, (3) facilitate communication with patients, (4) serve as a model for teaching residents and (5) shortening the learning curve in experienced urologists. Methodology: The design of the study is a randomized clinical trial, to determine the safety, precision, feasibility, predictability, efficacy and efficiency of a surgical strategy based on imaging tests and 3D models regarding the surgical planning in patients with RCa and VTT. This is a longitudinal, prospective, experimental and multicenter study on a cohort diagnosed of RCa and VTT from 2018 in the Virgen del Rocío University Hospital (HUVR) or in the Ramón y Cajal University Hospital (HURC). The study will last for 3 years and will be carried out jointly by the HUVR, the HURC and the IBIS, in a multidisciplinary team made up of urologists, radiologists and engineers.

Conditions

Renal Cell Carcinoma; Three-Dimensional; Venous Thromboses

Outcome Measures

Primary Outcomes (1)

• Grade of Concordance between the CT and the 3D model evaluated with the kappa and the intraclass correlation coefficient.

  The grade of concordance between the CT and 3D model will be assessed firstly identifying all the anatomical structures in the 3D model: Kidneys, tumor, arteries and veins.Then some measures will be taken both in the CT and the model to compare them. That will be repeated in 20 cases and the grade of concordance will be assessed by using the Kappa and the intraclass correlation coefficient.

  12 weeks, from the beginning of the study and before recruitment starts

Secondary Outcomes (10)

• Grade of concordance between the CT and/or 3D model and the vivo model evaluated with the kappa and the intraclass correlation coefficient.

  1 year, since the recruitment begins until we have the first 10 cases of renal cell carcinoma with thrombus venous extension operated

• Grade of predictability of the surgery planning with 3D and images compared with the surgery planning made only with images. It will be assessed by using the Kappa and the intraclass correlation coefficient.

  3 years, since the recruitment begins until the end of the recruitment.

• Surgery outcome in terms of blood transfusion (number of blood transfusions needed)

  3 years, since the recruitment begins until the end of the recruitment.

• Surgery outcome in terms of number and grade of complications according to Clavien's scale

  3 years, since the recruitment begins until the end of the recruitment.

• Surgery outcome in terms of free surgery margins according to the histopathology analysis of the specimen.

  3 years, since the recruitment begins until the end of the recruitment.

Study Arms (2)

3D printing + images

EXPERIMENTAL

Surgery planification with the combination of all the images available and a 3D biomodel printed from that images.

Device: 3D printing + images

Images

ACTIVE COMPARATOR

Surgery planification with all the images available

Other: Images

Interventions

3D printing + images DEVICE

To perform a surgery planification with the combination of the images available and the 3D biomodel in terms of: anticipation of potential complications and the human resources and necessary materials

3D printing + images

Images OTHER

To perform a surgery planification with the images available in terms of: anticipation of potential complications and the human resources and necessary materials

Images

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signature of informed consent.
• Age over 18 years or between 14 and 18 with the authorization from mother / father / guardian.
• Diagnosed of renal cancer with vascular involvement in the HUVR or HURC between 2018 and 2021

You may not qualify if:

• Pregnant.
• Immunosuppression.
• No signature of informed consent.
• Impossibility of monitoring or follow up.

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (2)

Ramón y Cajal University Hospital

Madrid, 28034, Spain

RECRUITING

Virgen del Rocio University Hospital

Seville, 41013, Spain

RECRUITING

Related Publications (17)

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• Rivero Belenchon I, Congregado Ruiz CB, Gomez Ciriza G, Gomez Dos Santos V, Burgos Revilla FJ, Medina Lopez RA. Impact of 3D-Printed Models for Surgical Planning in Renal Cell Carcinoma With Venous Tumor Thrombus: A Randomized Multicenter Clinical Trial. J Urol. 2025 May;213(5):568-580. doi: 10.1097/JU.0000000000004425. Epub 2025 Jan 21.

  PMID: 39836858 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell; Venous Thrombosis

Interventions

Imaging, Three-Dimensional

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Carmen Belén Congregado Ruíz, FEA

  Virgen del Rocío University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Inés Rivero Belenchón

CONTACT

679576719; ines.rivero.belenchon@gmail.com

María Aguilar Rodriguez

CONTACT

656663791; mariaguirod@yahoo.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study model: Longitudinal, prospective, experimental, multi centric on a cohort of patients diagnosed of Renal Cell Carcinoma with Vascular Involvement from 2018 in either the HUVR or the HURC

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: November 13, 2018
• Study Start: December 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: May 30, 2022
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Starting on november 2018 until may 2022
• Access Criteria: IPD and any additional supporting information will be shared, with any physician interested in the protocol, the biomodel the Statistical Analysis or the clinical study report. This information will be given always without revealing the identity of the participants of the study

Locations

ES (2)