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Integration of a Virtual Reality Environment for Percutaneous Renal Puncture in the Routine Clinical Practice of a Tertiary Department of Interventional Urology: A Feasibility Study Titolo presentazione sottotitolo Relatore: Correlatori: Milano, XX mese 20XX Prof. Elena De Momi Prof. Marco Elli Prof. Maurizio Vertemati Dr. Gianluca Sampogna Laureando: Greta Mondino (mat. 859232)

Collaborations The thesis, affiliated to the NearLAB of the Politecnico di Milano, was created in collaboration with: the Department of Biomedical Sciences and Clinics "Luigi Sacco", University of Milan at ASST Sacco Fatebenefratelli, Milan; the Departments of Radiology and Interventional Radiology of the Department of Advanced Diagnostic Therapeutic Technologies at the ASST Grande Metropolitan Hospital Niguarda, Milan. 2

Clinical Background: Kidney Anatomy Kidneys (or renal cavities) are parenchymal excretory organs, shaped bean, mainly composed by renal calyces and renal pelvis. They lie inside the abdominal cavity at the level of the 12th thoracic and first three lumbar vertebrae. The renal anatomy is constituted by a rich vascularization characterized by some differences between different individuals called anatomical intersubjective variabilities. There is not an ideal patient: each patient is unique. 3

Clinical Background: Kidney Pathologies There are some pathologies of the kidney, which if suspected, require a histological examination of a sample taken by biopsy. Kidney Stones Disease It is a clinical condition characterized by the presence of one or more variable-size stones (normally of around 4-5 mm) contained within the urinary system. Between 1% and 15% of people in the world have been hit by urinary calculus at some point in their life. Renal Tumors It is a neoplasia of this organ. There are several types of this. It affects about 330 thousand new cases every year in the world. 4

Clinical Background: Percutaneous Renal Puncture for Renal Biopsy The Renal Biopsy is a diagnostic technique that permit to take a tissue sample to be able to analyze it. The access to the kidney is realized thanks to a procedure called Percutaneous Renal Puncture. It is a mini-invasive approach that permit to minimize the surgical trauma. The access to kidney is realized piercing the skin with a very thin needle, behind the axillary axis and immediately above the 12 th rib, until it reaches a calyx in the kidney cavities. The procedure is performed using a double guide: the ultrasound guide and the radiological one. 5

Clinical Background: Related Issues and Possible Solutions The difficulty is due to the possible associated adverse effects, which sometimes may be fatal as haemorrhage, pleural injury or sepsis. Because of potential complications, trainees have difficulty gaining experience and they usually end their academic curriculum performing just few percutaneous renal punctures. HOW TO FACE THESE PROBLEMS? A virtual reality simulator for a percutaneous renal puncture might be an appropriate solution. Simulation is used in many branches of medicine to support the activity of the professionals and try to reduce human errors. 6

State of the Art: Virtual Reality Medical Simulators It can make learning surgical anatomy easier by allowing the student to explore the interrelations of various organ systems in perspectives not available through other standard teaching techniques (Satava, 1993) 1.Virtual Reality (VR) Hands-On 3. Haptics Simulator Perceiving the needle interaction forces could allow the surgeon to better estimate the position of the needle inside the tissue, enhance the accuracy in soft tissue identification (Enayati et al., 2016) VR-Simulation is defined as a technique to replace or amplify real experiences with guided experiences, often immersive in nature, that evoke or replicate substantial aspects of the real world in a fully interactive manner (Riaz A. Agha, 2015) 2. Simulation 7

State of the art: Limitations & Percutaneous Renal Puncture Simulators From the literature study twoperc major Mentor limitations TM emerge: No simulator in the Workstation: literature Virtual Reality presentsvirtual thereality possibility Environment Type of simulator of simulating on models Simulator concerning with a Flank a particular Box patient; Software There is no real use of these in clinical practice. LACE Tactile feedback YES YES Cost Conspicuous Negligible Given Possibility theseof observations, became this thesis is intended to be a feasibility study NO YES thatpatient-specific tries to fill these two shortcomings by going to work on a specific surgical Integration procedure in clinical (Percutaneous NO Renal Puncture) andyesa specific simulator. practice PERC Mentor TM LACE Virual Reality Environment 8

LACE Simulator The chosen simulator is called LACE. It is a virtual reality environment developed by four students of the NearLAB in collaboration with the University of Chicago. Properties: Platform developed in C ++; Physical configuration computer with Windows, mouse, keyboard and haptic device (Phantom Omni, Geomagic); Implementation configuration integration of four libraries o o o o Visualization Library Quick Haptics Computational geometry Library Electromagnetic tracking Library LACE consists of several classes in which the variables and functions used to allow virtual simulation are declared. 9

WHAT WE HAVE DONE 10

Aim of the Thesis 11

LACE as a Patient-Specific Simulator PATIENT CT EXAMS FROM NIGUARDA HOSPITAL 3D SLICER 3D SEGMENTATION OF EACH ORGAN CREATION OF MESHES AND DECIMATION EVALUATION OF THE USER PERFORMANCE Conversion of the file EXTRACTION OF TARGET COORDINATES O DATA ENTRY IN THE Patient FOLDER SIMULATION USER PERFOMANCE DATA CT SAMPLING Conversion of the file 12

CT Image Collection PATIENT CT EXAMS FROM NIGUARDA HOSPITAL 3D SLICER 3D SEGMENTATION OF EACH ORGAN CREATION OF MESHES AND DECIMATION EVALUATION OF THE USER PERFORMANCE Conversion of the file EXTRACTION OF TARGET COORDINATES O DATA ENTRY IN THE Patient FOLDER SIMULATION USER PERFOMANCE DATA CT SAMPLING Conversion of the file 13

CT Images Collection CT Images CT Images are based on a grey scale in which each value is proportional to the tissue density. To work on an anatomical district such as the abdomen, it was necessary to acquire a certain clinical eye to identify the regions of interest (abdomen organs and circulation pathway). HYPODENSE TISSUE HYPERDENSE TISSUE 14

Post-processing Phase PATIENT CT EXAMS FROM NIGUARDA HOSPITAL 3D SLICER 3D SEGMENTATION OF EACH ORGAN CREATION OF MESHES AND DECIMATION EVALUATION OF THE USER PERFORMANCE Conversion of the file EXTRACTION OF TARGET COORDINATES O DATA ENTRY IN THE Patient FOLDER SIMULATION USER PERFOMANCE DATA CT SAMPLING Conversion of the file 15

LACE as a Generic Simulator LACE as a Patient-Specific Simulator Nome 16 Cognome, assoc.prof. ABC Dept.

3D Slicer: 3D Reconstruction To realize a 3D Reconstruction with 3D Slicer it is necessary to perform for each organs of the abdomen cavity basically four steps: Uploading of the CT file in DICOM format from the Directory Perform a Semi-Automatic Segmentation Choice of the Volume-Rendering Effect Data (Meshes files) back-up as.stl format For the Semi-Automatic Segmentation we decide to use almost entirely a Thresholding Effect to select the regions of interest. For the Volume Rendering instead we have chosen to perform a Superficial Rendering based on triangulation. There are several ways to perform this process: the proposed one is what, in our opinion, provides a good result in the face of user-friendliness. 17

3D Slicer: Extraction of Target Coordinates and CT Sampling Extraction coordinates It is necessary to identify a target inside the 3D models to insert in LACE. Obviously, the operative target is different according to the patient of his pathology. We have used the function Place some Fiducials to extract and save point coordinates in mm. CT Sampling From the CT are extracted the information related to the fluoroscopy image, needed to perform the Percutaneous Renal Puncture. However, because of a limitation in LACE implementation choices, it is necessary to reduce the dimension of the CT files to permit a faster and optimized uploading of these on LACE Virtual Reality Environment. 18

Simulation on VRE and Outcomes PATIENT CT EXAMS FROM NIGUARDA HOSPITAL 3D SLICER 3D SEGMENTATION OF EACH ORGAN CREATION OF MESHES AND DECIMATION EVALUATION OF THE USER PERFORMANCE Conversion of the file EXTRACTION OF TARGET COORDINATES O DATA ENTRY IN THE Patient FOLDER SIMULATION USER PERFOMANCE DATA CT SAMPLING Conversion of the file 19

Simulation and Outcomes Before opening the Virtual Reality Environment, the user has to locate the files created previously inside the folder Patient specially created inside the directory. The VRE requires the access to ten different files: the sampled CT called CT sampled.mhd the original CT called CT.mhd the needle mesh called Needle.3ds and the organ meshes of the abdominal cavity that must be those of: o the kidneys, named kidneys.stl; o the spleen, named spleen.stl; o the lungs, named lungs.stl; o the skin, named skin.stl; o the liver, named liver.stl; o the ribs, named bone.stl; o and the circulation pathway, named circulation.stl. 20

Integration in Clinical Practice: Pre-operative Workflow Development The workflow has been developed mainly by interviewing surgeons who deal with the type of intervention we talked about previously. We can identify two pools, the Clinical Activity and the Surgical Unit Activity, divided in three different phases: Acceptance and Decision Making Phase (in green); Simulation Phase (in blue); Operative Block Activity and Immediate Post-Operative Phase (in yellow and orange). Several actors participate to this workflow, in particular: interventional radiologists, anesthesiologists and nurses. 21

Experimental Validation Protocol The validation is articulated in two main strands: verification of the possibility of using the simulator as a patient-specific simulator; the verification of the integration in the clinical field. Evaluation of LACE as a Patient-Specific Simulator It was necessary to verify that the implementation choices made to realize the workflow of the simulation process (tools used in 3D Slicer and settings of parameters chosen) could be valid for different types of CT images characterized by different dimensions (in terms of number of slices), different machines that produced them and therefore possible different reference systems. # slices along longitudinal axes 22

Experimental Validation Protocol Evaluation of the Work in terms of Ease of Use and Utility This evaluation was performed on the base of the questionnaire developed by us. It is a 13-points questionnaire based on a Likert Scale. 23

Conclusions and Future Developments In conclusion, for our knowledge, this simulator represents the first patient-specific virtual reality simulator to perform Percutaneous Renal Puncture access, representing a solid base for future studies like this. A big advantage of this work is the standardization of the processes because: The simulation workflow is valid for numerous applications of LACE; The integration workflow represents a good models for the integration of other technologies Future Developments Possible Developments can regard both software development and clinical trial: Implementation of ultrasound guide; Implementation of scene visualization through 3D glasses Improvement of number of clinical subjects and professionals 24

THANKS FOR YOUR ATTENTION! 25