Clinical trial NCT03738488: 3D-biomodels for Surgical Planning in Patients With Renal Cancer and Vascular Involvement
Official title: 3D-biomodels for Surgical Planning in Patients With Renal Cancer and Vascular Involvement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Cell Carcinoma
Three-Dimensional
Venous Thromboses
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 10
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: DEVICE_FEASIBILITY

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.

Detailed description: Phase 1, obtaining the 3D printed biomodel and study of feasibility.

Distribution of tasks: Conducted jointly by:

* Radiology team of the HUVR: Segmentation and 3D virtual reconstruction of the image tests. Compare measurements with image tests.
* IBIS / HUVR engineering team. Design and development of specific segmentation algorithm for the tissue selection of interest. Modeling of image and printing of the 3D model.
* Urology team of the HUVR. Identification of anatomical structures and taking measurements in the 3D model. Simulation of surgery following the surgical guide.
* Production center: It will be carried out entirely in the HUVR.
* Process: custom and manufacture 3D models to perform a surgical simulation using imaging tests of operated patients, with different characteristics until achieving an optimum prototype. Different anatomical structures will be measured and compared in the model and in the image (Collection sheet of data). Later, we will check if it is possible to perform a surgical simulation on the model reproducing in it each of the steps necessary to perform the surgery (surgical guide, annex 3).

Phase 2, precision and predictability study:

Distribution of tasks: Conducted jointly by:

* HUVR radiology team and HURC radiology team. Segmentation and 3D virtual reconstruction of the image tests. Taking measurements in image tests.
* IBIS / HUVR engineering team. 3D model printing.
* HUVR urology team and urology team HURC. Taking measurements in the 3D model. Surgical planning with imaging tests or with imaging tests and 3D model (simulation following the surgical guide).

Real surgery and taking measurements in real surgery.

* Production center: 3D printing in the HUVR, precision and predictability study, HUVR and HURC.
* Process: all patients diagnosed with CaR and TTV in the HUVR and HURC will be recruited between the years 2018 and 2021 and will be randomized into two groups. In the control group the surgical planning will be based exclusively on image tests. In the intervention group we will carry out a surgical planning based on imaging tests and the 3D model (on which we will perform a surgical simulation following the guide surgical). Subsequently, the surgery will be carried out, and in each of the groups it will be compared (Gold Standard) with the pre-surgical planning performed.
* precision study Anatomical measurements will be taken before the surgical intervention in the image models, in the 3D model and subsequently in vivo during surgery
* predictability study A prediction will be made of the type of surgery to be performed, the complications, and the necessary human and material resources.

Phase 3, efficacy and efficiency study:

* HUVR urology team and urology team HURC. Data Collect.
* Process: We will check if a surgical planning with image tests and 3D model makes the surgery more effective and efficient than the one based exclusively on imaging tests. Efficacy, will be defined as the ability to achieve a good surgical result. Efficiency will be defined as the ability to obtain good results with the minimum possible costs and in the minimum possible time.

Phase 4, study of satisfaction level with surgical planning based on 3D model and learning curve of urologists:

* HUVR Urology team and HURC urology team: Delivery of satisfaction surveys and data collection.
* HUVR urology team: Comparison of learning curves.

Final phase, analysis of the results and dissemination plan.

- All researchers: the results of the different tasks carried out in the project will be evaluated and scientific publications and communications in national and international congresses will be made.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Grade of Concordance between the CT and the 3D model evaluated with the kappa and the intraclass correlation coefficient.
timeFrame: 12 weeks, from the beginning of the study and before recruitment starts
Secondary outcomes:
measure: Grade of concordance between the CT and/or 3D model and the vivo model evaluated with the kappa and the intraclass correlation coefficient.
timeFrame: 1 year, since the recruitment begins until we have the first 10 cases of renal cell carcinoma with thrombus venous extension operated
measure: 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.
timeFrame: 3 years, since the recruitment begins until the end of the recruitment.
measure: Surgery outcome in terms of blood transfusion (number of blood transfusions needed)
timeFrame: 3 years, since the recruitment begins until the end of the recruitment.
measure: Surgery outcome in terms of number and grade of complications according to Clavien's scale
timeFrame: 3 years, since the recruitment begins until the end of the recruitment.
measure: Surgery outcome in terms of free surgery margins according to the histopathology analysis of the specimen.
timeFrame: 3 years, since the recruitment begins until the end of the recruitment.
measure: Surgery outcome in terms of number of hospitalisation days
timeFrame: 3 years, since the recruitment begins until the end of the recruitment.
measure: Surgery outcome in terms of necessity of stay in the Intensive Care Unit
timeFrame: 3 years, since the recruitment begins until the end of the recruitment.
measure: Cost-effectiveness analysis, comparing the cost of the surgery with the 3D planning and the image planning.
timeFrame: 3 years, after the recruitment is ended
measure: Comparison of learning curves using the CUSUM method.
timeFrame: 3 years, after the recruitment is ended and all the surgeries performed
measure: Satisfaction level, assessed by a specifically designed questionnaire to evaluate the satisfaction with the 3D model of both urologists and patients (questionnaire published in DOI 10.1007/s00345-015-1632-2 and https://doi.org/10.1007/s00345-017-2126-1)
timeFrame: 3 years. The satisfaction questionnaire to the patient will be given in the consult that the surgery is explained with the 3D model. At the end of the study, after the third year the satisfaction questionnaire will be given to all the urologists.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Ramón y Cajal University Hospital
city: Seville
country: Spain
facility: Virgen del Rocio University Hospital
Study officials:
affiliation: Virgen del Rocío University Hospital
name: Carmen Belén Congregado Ruíz, FEA
role: PRINCIPAL_INVESTIGATOR
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