3D-biomodels for Surgical Planning in Patients With Renal Cancer and Vascular Involvement
NCT ID: NCT03738488
Last Updated: 2021-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2019-12-01
2022-05-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DEVICE_FEASIBILITY
NONE
Study Groups
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3D printing + images
Surgery planification with the combination of all the images available and a 3D biomodel printed from that images.
3D printing + images
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
Images
Surgery planification with all the images available
Images
To perform a surgery planification with the images available in terms of: anticipation of potential complications and the human resources and necessary materials
Interventions
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3D printing + images
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
Images
To perform a surgery planification with the images available in terms of: anticipation of potential complications and the human resources and necessary materials
Eligibility Criteria
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Inclusion Criteria
* 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
* Immunosuppression.
* No signature of informed consent.
* Impossibility of monitoring or follow up.
14 Years
ALL
No
Sponsors
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
OTHER
Responsible Party
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Principal Investigators
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Carmen Belén Congregado Ruíz, FEA
Role: PRINCIPAL_INVESTIGATOR
Virgen del Rocío University Hospital
Locations
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Ramón y Cajal University Hospital
Madrid, , Spain
Virgen del Rocio University Hospital
Seville, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Trials 3D Urologia
Identifier Type: -
Identifier Source: org_study_id
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