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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.
Phase 1, obtaining the 3D printed biomodel and study of feasibility.
Distribution of tasks: Conducted jointly by:
Phase 2, precision and predictability study:
Distribution of tasks: Conducted jointly by:
Real surgery and taking measurements in real surgery.
Phase 3, efficacy and efficiency study:
Phase 4, study of satisfaction level with surgical planning based on 3D model and learning curve of urologists:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D printing + images | Experimental | Surgery planification with the combination of all the images available and a 3D biomodel printed from that images. |
|
| Images | Active Comparator | Surgery planification with all the images available |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Inés Rivero Belenchón | Contact | 679576719 | +34 | ines.rivero.belenchon@gmail.com |
| María Aguilar Rodriguez | Contact | 656663791 | +34 | mariaguirod@yahoo.es |
| Name | Affiliation | Role |
|---|---|---|
| Carmen Belén Congregado Ruíz, FEA | Virgen del Rocío University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ramón y Cajal University Hospital | Recruiting | Madrid | 28034 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18313224 | Background | Gupta K, Miller JD, Li JZ, Russell MW, Charbonneau C. Epidemiologic and socioeconomic burden of metastatic renal cell carcinoma (mRCC): a literature review. Cancer Treat Rev. 2008 May;34(3):193-205. doi: 10.1016/j.ctrv.2007.12.001. Epub 2008 Mar 4. | |
| 26099870 | Background | Knoedler M, Feibus AH, Lange A, Maddox MM, Ledet E, Thomas R, Silberstein JL. Individualized Physical 3-dimensional Kidney Tumor Models Constructed From 3-dimensional Printers Result in Improved Trainee Anatomic Understanding. Urology. 2015 Jun;85(6):1257-61. doi: 10.1016/j.urology.2015.02.053. |
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All IPD that underlie results in a publication will be shared, as well as the study protocol, the Statistical Analysis Plan, the Informed Consent Form and the Clinical Study Report
Starting on november 2018 until may 2022
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
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D021621 | Imaging, Three-Dimensional |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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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
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| 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 |
|
| 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. | 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| 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 |
| 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. |
| Virgen del Rocio University Hospital | Recruiting | Seville | 41013 | Spain |
|
| 24125174 | Background | Hatakeyama S, Yoneyama T, Hamano I, Murasawa H, Narita T, Oikawa M, Hagiwara K, Noro D, Tanaka T, Tanaka Y, Hashimoto Y, Koie T, Ohyama C. Prognostic benefit of surgical management in renal cell carcinoma patients with thrombus extending to the renal vein and inferior vena cava: 17-year experience at a single center. BMC Urol. 2013 Oct 14;13:47. doi: 10.1186/1471-2490-13-47. |
| 12559273 | Background | Bissada NK, Yakout HH, Babanouri A, Elsalamony T, Fahmy W, Gunham M, Hull GW, Chaudhary UB. Long-term experience with management of renal cell carcinoma involving the inferior vena cava. Urology. 2003 Jan;61(1):89-92. doi: 10.1016/s0090-4295(02)02119-2. |
| 17561151 | Background | Blute ML, Boorjian SA, Leibovich BC, Lohse CM, Frank I, Karnes RJ. Results of inferior vena caval interruption by greenfield filter, ligation or resection during radical nephrectomy and tumor thrombectomy. J Urol. 2007 Aug;178(2):440-5; discussion 444. doi: 10.1016/j.juro.2007.03.121. Epub 2007 Jun 11. |
| 1875477 | Background | Craven WM, Redmond PL, Kumpe DA, Durham JD, Wettlaufer JN. Planned delayed nephrectomy after ethanol embolization of renal carcinoma. J Urol. 1991 Sep;146(3):704-8. doi: 10.1016/s0022-5347(17)37899-0. |
| 25430786 | Background | Psutka SP, Boorjian SA, Thompson RH, Schmit GD, Schmitz JJ, Bower TC, Stewart SB, Lohse CM, Cheville JC, Leibovich BC. Clinical and radiographic predictors of the need for inferior vena cava resection during nephrectomy for patients with renal cell carcinoma and caval tumour thrombus. BJU Int. 2015 Sep;116(3):388-96. doi: 10.1111/bju.13005. Epub 2015 Mar 23. |
| 10188125 | Background | D'Urso PS, Barker TM, Earwaker WJ, Bruce LJ, Atkinson RL, Lanigan MW, Arvier JF, Effeney DJ. Stereolithographic biomodelling in cranio-maxillofacial surgery: a prospective trial. J Craniomaxillofac Surg. 1999 Feb;27(1):30-7. doi: 10.1016/s1010-5182(99)80007-9. |
| 22337427 | Background | Levine JP, Patel A, Saadeh PB, Hirsch DL. Computer-aided design and manufacturing in craniomaxillofacial surgery: the new state of the art. J Craniofac Surg. 2012 Jan;23(1):288-93. doi: 10.1097/SCS.0b013e318241ba92. |
| 19758813 | Background | Shiraishi I, Yamagishi M, Hamaoka K, Fukuzawa M, Yagihara T. Simulative operation on congenital heart disease using rubber-like urethane stereolithographic biomodels based on 3D datasets of multislice computed tomography. Eur J Cardiothorac Surg. 2010 Feb;37(2):302-6. doi: 10.1016/j.ejcts.2009.07.046. Epub 2009 Sep 15. |
| 25991234 | Background | Suarez-Mejias C, Gomez-Ciriza G, Valverde I, Parra Calderon C, Gomez-Cia T. New technologies applied to surgical processes: Virtual Reality and rapid prototyping. Stud Health Technol Inform. 2015;210:669-71. |
| 24809416 | Background | Valverde I, Gomez G, Gonzalez A, Suarez-Mejias C, Adsuar A, Coserria JF, Uribe S, Gomez-Cia T, Hosseinpour AR. Three-dimensional patient-specific cardiac model for surgical planning in Nikaidoh procedure. Cardiol Young. 2015 Apr;25(4):698-704. doi: 10.1017/S1047951114000742. Epub 2014 May 9. |
| 25557983 | Background | Valverde I, Gomez G, Coserria JF, Suarez-Mejias C, Uribe S, Sotelo J, Velasco MN, Santos De Soto J, Hosseinpour AR, Gomez-Cia T. 3D printed models for planning endovascular stenting in transverse aortic arch hypoplasia. Catheter Cardiovasc Interv. 2015 May;85(6):1006-12. doi: 10.1002/ccd.25810. Epub 2015 Feb 12. |
| 28977423 | Background | Valverde I, Gomez-Ciriza G, Hussain T, Suarez-Mejias C, Velasco-Forte MN, Byrne N, Ordonez A, Gonzalez-Calle A, Anderson D, Hazekamp MG, Roest AAW, Rivas-Gonzalez J, Uribe S, El-Rassi I, Simpson J, Miller O, Ruiz E, Zabala I, Mendez A, Manso B, Gallego P, Prada F, Cantinotti M, Ait-Ali L, Merino C, Parry A, Poirier N, Greil G, Razavi R, Gomez-Cia T, Hosseinpour AR. Three-dimensional printed models for surgical planning of complex congenital heart defects: an international multicentre study. Eur J Cardiothorac Surg. 2017 Dec 1;52(6):1139-1148. doi: 10.1093/ejcts/ezx208. |
| 24137230 | Background | Infante-Cossio P, Prats-Golczer V, Gonzalez-Perez LM, Belmonte-Caro R, Martinez-DE-Fuentes R, Torres-Carranza E, Gacto-Sanchez P, Gomez-Cia T. Treatment of recurrent mandibular ameloblastoma. Exp Ther Med. 2013 Aug;6(2):579-583. doi: 10.3892/etm.2013.1165. Epub 2013 Jun 18. |
| 26933631 | Background | Hevia V, Ciancio G, Gomez V, Alvarez S, Diez-Nicolas V, Burgos FJ. Surgical technique for the treatment of renal cell carcinoma with inferior vena cava tumor thrombus: tips, tricks and oncological results. Springerplus. 2016 Feb 20;5:132. doi: 10.1186/s40064-016-1825-1. eCollection 2016. |
| 39836858 | Derived | 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. |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |