Renal Cell Carcinoma Clinical Trial
— 3DUrologiaOfficial title:
3D-biomodels for Surgical Planning in Patients With Renal Cancer and Vascular Involvement
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | May 30, 2022 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Ramón y Cajal University Hospital | Madrid | |
Spain | Virgen del Rocio University Hospital | Seville |
Lead Sponsor | Collaborator |
---|---|
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla |
Spain,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Grade of concordance between the CT and/or 3D model and the vivo model evaluated with the kappa and the intraclass correlation coefficient. | The grade of concordance between the CT and/or 3D model and the "vivo" will be assessed firstly identifying all the anatomical structures in the CT or 3D and the vivo when the surgery is performed: Kidneys, tumor, arteries and veins.Then some measures will be taken both in the CT and or 3D and the vivo during the surgery to compare them. The grade of concordance will be assessed by using 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 | |
Secondary | 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. | A pre-surgery planning will be made to predict the kind of surgery, the potential complications and the human and material necessary resources for the surgery. Both predictions (the one made only with images, and the one made with images and 3D) will be compared with the reality (the surgery). The grade of concordance between the prediction and the reality will be assessed using the Kappa and the intraclass correlation coefficient. | 3 years, since the recruitment begins until the end of the recruitment. | |
Secondary | Surgery outcome in terms of blood transfusion (number of blood transfusions needed) | We will compare the surgery outcomes between the surgery pre-planned with images and the one pre-planned with 3D and images. That will be assessed in terms of blood transfusion (number of blood transfusiones needed) | 3 years, since the recruitment begins until the end of the recruitment. | |
Secondary | Surgery outcome in terms of number and grade of complications according to Clavien's scale | We will compare the surgery outcomes between the surgery pre-planned with images and the one pre-planned with 3D and images. That will be assessed in terms of number and grade of complications following the Clavien's scale. | 3 years, since the recruitment begins until the end of the recruitment. | |
Secondary | Surgery outcome in terms of free surgery margins according to the histopathology analysis of the specimen. | We will compare the surgery outcomes between the surgery pre-planned with images and the one pre-planned with 3D and images. That will be assessed in terms of free surgery margins according to the histopathology analysis of the specimen (yes/no) | 3 years, since the recruitment begins until the end of the recruitment. | |
Secondary | Surgery outcome in terms of number of hospitalisation days | We will compare the surgery outcomes between the surgery pre-planned with images and the one pre-planned with 3D and images. That will be assessed in terms of number of hospitalisation days | 3 years, since the recruitment begins until the end of the recruitment. | |
Secondary | Surgery outcome in terms of necessity of stay in the Intensive Care Unit | We will compare the surgery outcomes between the surgery pre-planned with images and the one pre-planned with 3D and images. That will be assessed in terms of necessity of stay in the Intensive Care Unit (yes/no) | 3 years, since the recruitment begins until the end of the recruitment. | |
Secondary | Cost-effectiveness analysis, comparing the cost of the surgery with the 3D planning and the image planning. | Cost-effectiveness analysis, comparing the cost of the surgery with the 3D planning (sum of the impression, the surgery and the postoperative time) and the surgery performed with an image planning. | 3 years, after the recruitment is ended | |
Secondary | Comparison of learning curves using the CUSUM method. | We will compare the learning curve of the surgeon that starts its training practicing in a 3D model and the one of a surgeon that did the learning curve without training in the 3D model | 3 years, after the recruitment is ended and all the surgeries performed | |
Secondary | 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) | A questionnaire will be given to each patient in the consult after the explanation of the surgery with the 3D model (2 questionnaire published in DOI 10.1007/s00345-015-1632-2) In addition, at the end of the study, another satisfaction questionnaire will be given to all the urologists that participated in the study using a questionnaire already used (https://doi.org/10.1007/s00345-017-2126-1) | 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. |
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