3D-biomodels for Surgical Planning in Patients With Renal Cancer and Vascular Involvement
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Grade of Concordance between the CT and the 3D model evaluated with the kappa and the intraclass correlation coefficient.
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Pregnant.
- •Immunosuppression.
- •No signature of informed consent.
- •Impossibility of monitoring or follow up.
结局指标
主要结局
Grade of Concordance between the CT and the 3D model evaluated with the kappa and the intraclass correlation coefficient.
时间窗: 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.
次要结局
- Surgery outcome in terms of blood transfusion (number of blood transfusions needed)(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.(3 years, since the recruitment begins until the end of the recruitment.)
- Comparison of learning curves using the CUSUM method.(3 years, after the recruitment is ended and all the surgeries performed)
- Grade of concordance between the CT and/or 3D model and the vivo model evaluated with 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)
- 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.(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(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(3 years, since the recruitment begins until the end of the recruitment.)
- 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)(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.)
- Cost-effectiveness analysis, comparing the cost of the surgery with the 3D planning and the image planning.(3 years, after the recruitment is ended)
- Surgery outcome in terms of number of hospitalisation days(3 years, since the recruitment begins until the end of the recruitment.)