Neoplasms

All Conditions

Heart and Blood Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Thrombosis

Venous Thrombosis

Carcinoma, Renal Cell

Kidney Neoplasms

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Embolism

Embolism and Thrombosis

Vascular Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Surgery planification with the combination of all the images available and a 3D biomodel printed from that images.

Surgery planification with all the images available

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

3D printing + images

To perform a surgery planification with the images available in terms of: anticipation of potential complications and the human resources and necessary materials

Images

Inés Rivero Belenchón

María Aguilar Rodriguez

Victoria Gomez Dos Santos

Laura Illana Reyero

Francisco Javier Burgos Revilla

Ines Rivero Belenchon

María Aguilar Rodríguez

Carmen Belén Congregado Ruíz

Carmen Belén Congregado Ruíz, FEA

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:

* 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 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

3D-biomodels for Surgical Planning in Patients With Renal Cancer and Vascular Involvement

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

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.

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.

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.

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)

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.

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)

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

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)

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.

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

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)

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Symptoms and General Pathology

Digestive System Diseases

Ulcer

Crohn Disease

Colitis

Colitis, Ulcerative

Thromboembolism

Venous Thromboembolism

Diverticulum

Diverticular Diseases

Gastrointestinal Diseases

Intestinal Diseases

Inflammatory Bowel Diseases

Gastroenteritis

Pathological Conditions, Anatomical

Coagulants

All Drugs and Chemicals

Anticoagulants

Fibrin fragment D

Fibrin Fibrinogen Degradation Products

Antifibrinolytic Agents

Hemostatics

Subjects who meet the inclusion criteria that will have colorectal surgery at UTMB

D-dimer blood test- The D-dimer assay detects the presence of fibrin degradation products, which can indicate the breakdown of a fibrin clot Lower Limb Venous Duplex- Using an ultrasound to visually look for a clot

D-dimer and lower limb venous duplex

Uma Phatak, MD

The purpose of this study is to evaluate the use of a D-dimer based protocol to screen for thrombotic events in colorectal surgical patients. This study is unique because of the multistage screening process for DVT's using a standardized D-dimer testing methodology and ultrasound that will take place throughout the preoperative, perioperative, and postoperative processes. The data collected from this screening study will help establish the baseline DVT rates in UTMB's colorectal surgical patients before and after surgery. Additionally, the data from this study can help determine if a D-dimer blood test has predictive value in UTMB's colorectal surgical patient population. This study may also provide preliminary evidence for further research regarding the adjustment of D-dimer cutoff values. Specifically for patient subsets such as surgical colorectal patients with a moderate pretest probability and clinical conditions associated with low test specificity

This will be a quantitative prospective cohort study conducted at the University of Texas Medical Branch (UTMB) Galveston and League City campuses. Candidates include subjects who will have elective colorectal surgery at UTMB. This study looks to enroll 100 subjects who meet inclusion criteria. The subjects will undergo screening for DVT using a lower limb bilateral venous duplex and a plasma D-dimer assay no longer than 10 days before their operation. This data will be used to observe the point prevalence of DVT's in preoperative colorectal subjects prior to having colorectal surgery. On the day of surgery, the subject will have a D-dimer test. After the operation, for next 2 days the subjects will have a daily D-dimer test and a lower limb bilateral venous duplex on the second day only. This data will determine the incidence of DVT's that were detected by lower limb bilateral venous duplex on inpatient stay day 2 and possibly indicated by an upward trending D-dimer value during the first 2 days of the inpatient stay. Approximately 2 weeks after surgery, at the postoperative clinic appointment, the subject will have a D-dimer assay and a lower limb bilateral venous duplex. This information will be used to determine the number of DVT events in postoperative colorectal hospitalized subjects that were on the D-dimer monitoring protocol. The D-dimer assay detects the presence of fibrin degradation products, which may indicate a fibrin blood clot in the body.6 A maximum of 5 milliliters of blood will be collected for each D-dimer test. If a DVT is detected by the gold standard method which is a bilateral lower limb duplex during any point of study, the subject will be treated as per standard of care at UTMB by the colorectal surgical team

The Correlation of a D-dimer Testing Protocol With Venous Thromboembolism in Surgical Colorectal Patients

The data will be used to discover the prevalence of DVT prior to surgery and to establish DVT baseline rates at UTMB.

Subjects will have a venous duplex on day two after surgery to look for a DVT

The data will be used to determine the number of DVT's that were discovered in the subject population and to establish baseline rates of DVT after surgery and hospital discharge

This data will be used to compare the D-dimer values in subjects that had DVT prior to surgery to those who developed a postoperative DVT while inpatient or at the postoperative clinic appointment

These results will be used as preliminary evidence for future research to determine if revised D-dimer cut off values can be diagnostic in conditions known to have low test specificity

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
3D-biomodels for Surgical Planning in Patients With Renal Cancer and Vascular Involvement	NCT03738488	Renal Cell Carc... Three-Dimension... Venous Thrombos...	3D printing + i... Images	14 Years -	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
The Correlation of a D-dimer Testing Protocol With Venous Thromboembolism in Surgical Colorectal Patients	NCT05246943	Venous Thrombos... Colorectal Canc... Diverticular Di... Crohn Disease Ulcerative Coli... Deep Vein Throm...	D-dimer and low...	18 Years -	The University of Texas Medical Branch, Galveston
The Correlation of a D-dimer Testing Protocol With Venous Thromboembolism in Surgical Colorectal Patients	NCT05246943	Venous Thrombos... Colorectal Canc... Diverticular Di... Crohn Disease Ulcerative Coli... Deep Vein Throm...	D-dimer and low...	18 Years -	The University of Texas Medical Branch, Galveston

Spots Global Cancer Trial Database for venous thromboses