Renal Cell Carcinoma3DUrologiaNCT03738488
3D-biomodels for Surgical Planning in Patients With Renal Cancer and Vascular Involvement
A study testing 3D printing + images and Images in people with Renal Cell Carcinoma and Three-Dimensional, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 2 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Three-Dimensional, Venous Thromboses
- What is being tested?
- 3D printing + images and Images
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Dec 2019to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant.
- Immunosuppression.
- No signature of informed consent.
- Impossibility of monitoring or follow up.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Ramón y Cajal University Hospital
Madrid, 28034
Victoria Gomez Dos Santos, 670795972 ext. +34, vgomezd69@gmail.com
Laura Illana Reyero, 618 11 73 25 ext. +34, laillana.reyero@gmail.com
- Recruiting
Virgen del Rocio University Hospital
Seville, 41013
Ines Rivero Belenchon, 679576719 ext. +34, ines.rivero.belenchon@gmail.com
María Aguilar Rodríguez, 656663791 ext. +34, mariaguirod@yahoo.es
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Renal Cell Carcinoma, Three-Dimensional, Venous Thromboses
- Being tested
- 3D printing + images, Images
- Medical subject headings
- Carcinoma, Renal Cell, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printing + imagesDevice
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
ImagesOther
To perform a surgery planification with the images available in terms of: anticipation of potential complications and the human resources and necessary materials
| Study group | Role | What they receive |
|---|---|---|
| 3D printing + images | Experimental | Surgery planification with the combination of all the images available and a 3D biomodel printed from that images. Receives: Device: 3D printing + images |
| Images | Active comparator | Surgery planification with all the images available Receives: Other: Images |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start1 Dec 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carmen Belén Congregado Ruíz, FEA, Principal investigator, Virgen del Rocío University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738488
- Sponsor's protocol ID
- Trials 3D Urologia
- Acronym
- 3DUrologia
- Status last verified
- Jan 2021
- First submitted
- 18 Oct 2018
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 18313224Knoedler 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.
PubMed 26099870Hatakeyama 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.
PubMed 24125174Bissada 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.
PubMed 12559273Blute 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.
PubMed 17561151Craven 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.
PubMed 1875477Psutka 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.
PubMed 25430786D'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.
PubMed 10188125Levine 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.
PubMed 22337427Shiraishi 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.
PubMed 19758813Suarez-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.
PubMed 25991234Valverde 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.
PubMed 24809416Valverde 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.
PubMed 25557983Valverde 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.
PubMed 28977423Infante-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.
PubMed 24137230
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D-biomodels for Surgical Planning in Patients With Renal Cancer and Vascular Involvement
- ClinicalTrials.gov ID
- NCT03738488
- Acronym / sponsor ID
- 3DUrologia / Trials 3D Urologia
- Conditions
- Renal Cell Carcinoma, Three-Dimensional, Venous Thromboses
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| 3D printing + images | Experimental | Device: 3D printing + imagesSurgery planification with the combination of all the images available and a 3D biomodel printed from that images. |
| Images | Active comparator | Other: ImagesSurgery planification with all the images available |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnant.
- Immunosuppression.
- No signature of informed consent.
- Impossibility of monitoring or follow up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D printing + imagesTo 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 | Device | 3D printing + images |
| ImagesTo perform a surgery planification with the images available in terms of: anticipation of potential complications and the human resources and necessary materials | Other | Images |
Primary outcome
Grade of Concordance between the CT and the 3D model evaluated with the kappa and the intraclass correlation coefficient.
Time frame: 12 weeks, from the beginning of the study and before recruitment starts
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.
10 secondary outcomes
Grade of concordance between the CT and/or 3D model and the vivo model evaluated with the kappa and the intraclass correlation coefficient.
Time frame: 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.
Time frame: 3 years, since the recruitment begins until the end of the recruitment.
Surgery outcome in terms of blood transfusion (number of blood transfusions needed)
Time frame: 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
Time frame: 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.
Time frame: 3 years, since the recruitment begins until the end of the recruitment.
Surgery outcome in terms of number of hospitalisation days
Time frame: 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
Time frame: 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.
Time frame: 3 years, after the recruitment is ended
Comparison of learning curves using the CUSUM method.
Time frame: 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)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Background: PubMed 18313224Gupta 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.
- Background: PubMed 26099870Knoedler 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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- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Belén Congregado Ruíz, FEA principal investigator
Virgen del Rocío University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printing + images and Images in people with Renal Cell Carcinoma and Three-Dimensional, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Inés Rivero Belenchón (679576719 ext. +34, ines.rivero.belenchon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade of Concordance between the CT and the 3D model evaluated with the kappa and the intraclass correlation coefficient. (time frame: 12 weeks, from the beginning of the study and before recruitment starts). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03738488, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021; AzTrials last refreshed its copy on 8 Nov 2026.