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practice PASSPORT *

PASSPORT *

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Acronym of the case:

PASSPORT

Web address of the case:

Country of the case:

France , Germany , Switzerland , United Kingdom

Posting Date:

6 May 2011

Last Edited Date:

16 May 2011

Author:

Pamela LHOTE (IRCAD)
PASSPORT * Logoplhote's picture
Editor's Choice 2011

Type of initiative

  • Project or service-imgProject or service

Case Abstract

*PAtient Specific Simulation and PreOperative Realistic Training for liver surgery

 

Surgery has the best survival rate in liver pathologies. However, the eligibility is limited due to a bad knowledge of each patient's hepatic specificities. PASSPORT will provide new models and tools to overcome such limits.

In 2006, over 45.000 European citizens died of cirrhosis of the liver and 44,000 additional citizens of liver cancer, and 48,700 new liver cancer cases were declared. Surgical procedures remain the options that offer the highest success rate against such pathologies. Regretfully, surgery is not so frequent due to several limitations.

Indeed, eligibility for liver surgery is based on the minimum safety liver volume remaining after resection (standardized FLR), but this minimum value varies over time and from one patient to another according to biological and mechanical properties of the liver. Since 1996, a large number of preoperative planning software has been developed, but all of them provide only the volume of the liver before and after resection. However interesting, this limited information is not sufficient to improve the rate of surgical eligibility. PASSPORT for Liver Surgery aims at overcoming these limitations by offering a patient-specific modelling that combines anatomical, mechanical, appearance and biological preoperative modelled information in a unified model of the patient. This first complete "Virtual liver" will be developed in an Open Source Framework allowing vertical integration of biomedical data, from macroscopic to microscopic patient information.

From these models, a dynamic liver modelling will provide the patient-specific minimum safety standardized FLR in an educative and preoperative planning simulator allowing to predict the feasibility of the gesture and surgeons ability to realise it. Thus, any patient will be able to know the risk level of a proposed therapy. Finally, we expect to increase the rate of surgical treatment so as to save patients with a liver pathology. To reach these aims, PASSPORT is composed of a high-level partnership between internationally renowned surgical teams, leading European research teams in surgical simulation and an international leading company in surgical instrumentation.

Description of the case

Domain
Sector
Date
June 2008 to May 2011
Target Users
Health authorities | Health professionals
Scope
International
Language(s)
English

Policy Context and Legal Framework

Eligibility for liver surgery is based on various criteria and rules defined for partial liver resection and transplants. Liver transplants in Europe represents 5, 000 procedures per year (source European Liver Transplant Registry). However, this remains limited by the number of possible donors and specific rules such as the Milan criteria limiting transplants to patients with a single nodule of less than 5 cm or up to three nodules with none larger than 3 cm. Fortunately, organ transplant is not the only solution. Indeed, the liver is able to regenerate its substance. This means that when part of the liver is removed, the volume of the remaining liver increases until it approaches the volume of the original entire liver. Bile ducts and blood vessels do not grow back, so it is essential to preserve these vascular networks as much as possible. The 2006 San Francisco consensus conference established that two adjacent liver segments can be separated with an adequate vascular inflow and outflow as well as biliary drainage and that the standardized Future Liver Remnant (Standardized FLR = remnant liver volume/liver volume) must be over 20% for patients with an otherwise normal liver, 30% for patients who have received extensive preoperative systemic chemotherapy, and 40% for patients with existing chronic liver diseases such as hepatitis, fibrosis or cirrhosis. This recent consensus clearly shows that the eligibility for resection is not only based on geometrical information (such as the total volume of the liver) or topological information (such as vascular networks) that can be extracted from 3D medical imaging (CT-scan or MRI), but also on clinical signs obtained by physical aspects and patient examinations as well as symptoms, for instance, pain, functional problems, discomfort, etc. and finally on functional and physiological information that are essentially provided by blood analysis and/or biopsies. All this information is used by practitioners who decide, from their own knowledge, the best therapy to apply to their patients. Although today, this knowledge is improved by new technology, unfortunately there is no system that allows the management of these various data linking patient health information to the practitioner's knowledge in which to apply the best therapy. Moreover, no system today provides a patient specific minimal safety standardized FLR, which in the end result is the most important criteria when deciding upon surgical eligibility. The final decision is thus totally dependent on the practitioner's personal experience and feeling.

The PASSPORT for Liver Surgery project fully addresses the expectations of the ICT work programmes and in particular, Challenge 5, "towards sustainable and personalised healthcare". More specifically, this 3-year project deals directly with the objectives of the "Virtual Physiological Human" ICT-2007.5.3 objective. Indeed, PASSPORT's aim is to develop patient-specific models of the liver which integrates anatomical, functional, mechanical, appearance, and biological modelling. To these static models, PASSPORT will add dynamics liver deformation modelling and deformation due to breathing, and regeneration modelling providing a patient specific minimal safety standardized FLR. These models, integrated in the Open Source framework SOFA, will culminate in generating the first multi-level and dynamic "Virtual patient-specific liver" allowing not only to accurately predict feasibility, results and the success rate of a surgical intervention, but also to improve surgeons' training via a fully realistic simulator, thus directly impacting upon definitive patient recovery suffering from liver diseases.

Project Size and Implementation

Type of initiative
IT infrastructures and products
Overall Implementation approach
Partnerships between administration and/or private sector and/or non-profit sector
Technology choice
Not applicable/not available
Funding source
Public funding EU
Project size
Implementation: €5,000,000-10,000,000
Yearly cost:
€1,000,000-5,000,000

Implementation and Management Approach

To reach the PASSPORT for Liver Surgery scientific and technological objectives, we have developed a 3-year schedule composed of 11 work packages.

  • WP1 Patient-Specific Anatomical Modelling
  • WP2: Patient-Specific Mechanical Modelling
  • WP3: Patient-Specific Appearance Modelling
  • WP4: Patient-Specific Biological Modelling
  • WP5: Patient-Specific Dynamic modelling
  • WP6: Patient-Specific Vertical integration
  • WP11 Patient-Specific intraoperative integration
  • WP7: Patient-Specific surgical planning and simulation
  • WP8: Clinical Validation
  • WP9: Dissemination
  • WP10: Strategic, operational and IPR/Foreground Management

The first step will consist in defining the 4 anatomical, mechanical, appearance and biological models on all information available on liver pre-operatives and surrounding anatomical and pathological structures. It includes anatomical information extracted from CT-scan, MRI or US, mechanical properties extracted from elastographic imaging, functional and biological information extracted from biopsy and blood analysis. These first 4 Work Packages will each be dedicated to the development of one specific model.

The Fifth Work Package will consist in adding dynamics to this static modelling through the development of organ motion and deformation modelling. All these 5 models will then be integrated (WP6) in an open source framework allowing to exploit them in a unified patient-specific modelling, which is the "heart" of the PASSPORT project.

As a result of all these data, the next step (WP7) will consist in developing patient-specific pre-operative liver surgery planning, not only limited to liver volume and geometry, but also integrating the previous unified modelling by providing the minimal safety standardized FLR. In parallel to this development, we will develop patient-specific simulators for liver surgery allowing i) the education of such procedures, and ii) pre-operative simulation. Described models will be integrated for simulation on an international open source platform allowing not only a better dissemination of results, but also a possible extension of results in other areas of the human body as well as other types of pathology.

All these research developments will lead to demonstration software which will be evaluated and tested by medical experts in liver surgery through WP8. This work package will also include the validation of progressive results extracted from the first five work packages.

Due to the large number of static or dynamic models, PASSPORT is based on a large number of renowned partners or associated partners; each specialized in one or two modelling techniques or providing a clinical validation of the result. Each hospital and surgical team will be directly involved, as associated partners in the validation of project outcomes which is vital for the development and success of these types of technology.

Impact, innovation and results

Impact

Geometrical and anatomical modelling:

After two years, PASSPORT has already reached several of its objectives. The first task (workpackage, in short WP) of the project has thus led to a new automated and fast segmentation of thoraco-abdominal CT-scan images and a new liver and surrounding organs segmentation from US. It also provided a new mesh generation algorithm providing topologically correct meshes of segmented organs. In the same way, it allowed the integration of a mesh refinement algorithm in a framework dedicated to mesh and also the automatic quality estimation thanks to dedicated metrics that will be used for instance to both estimate the quality of a mesh for visualisation and for deformation simulation.

Moreover, this first WP has defined a new anatomical segmentation of the liver that avoids current anatomical mistakes and therefore improves the postoperative success of liver surgery. This new topologically correct patient-specific anatomy is based on the result of the state of the art in liver anatomy that showed that Couinaud's anatomy was correct in only 40% of cases.

Mechanic, texture, biology and dynamic models:

The second WP that aims at developing patient-specific mechanical modelling, has allowed the development of a new MRI Elastographic (MRE) acquisition. Comparison with the Transcient US elastography clearly demonstrates greater quality of such modelling providing fewer errors in fibrosis detection. From an in vitro and experimental in vivo evaluation, we have also obtained a first Finite Model element of a liver that will be completed and linked to the MRE information during the upcoming last year of the project.

The third WP has provided an organ texture database from HD endoscopic views of real patients with and without liver pathologies. This database has been used to develop new high-speed texture-rendering techniques providing a fully realistic rendering. Moreover, an automatic texture generation from endoscopic views of patients has been developed.

The fourth WP was aiming at providing biological modelling of the liver. Results achieved offer today the first effective simulation of liver cell regeneration. Moreover, MRI perfusion and diffusion image analysis developed in this WP offer the possibility to characterize liver pathologies from a MRI medical image. These results will have to be more precisely validated during the last year of the project.

Hepatic lobule regeneration simulation: cell scale. The fifth WP is focusing on the dynamic modelling of liver movements. Several motion models have been derived from real-time MRI acquisitions, ultrasonic images, endoscopic images and external camera. First validations show a possible predictive simulation of liver movements during breathing cycles with a 2 mm precision.

Integration:

Thanks to WP6, the various models are progressively integrated in an opensource framework dedicated to surgical simulation: SOFA (www.sofa-framework.org). It allows the development of patient-specific simulation, a first educative version having already been developed.

Moreover, several softwares have been developed in the integration WP7 from a new opensource framework dedicated to computer-assisted surgical software development (code.google.com/p/fw4spl).

The first one, 3D VPM 2.0, integrates new segmentation and modelling algorithms and can be used in another medical field of the Virtual Physiological Human. The second one, VR-Render©IRCAD2010, a freeware available on the PASSPORT website, is a new DICOM viewer, integrating direct volume rendering techniques (that do not require organ modelling) and surface-rendering techniques (after organ modelling). The initial patient medical image and resulting segmented organs can thus be easily visualized with this free user friendly software. The third one, VRRender WebSurg Limited Edition ©IRCAD2010, is an educative version of VR-Render available freely on the free online virtual university WebSurg. It allows to link the patient modelling to an educative video of the surgery applied to the same patient. The last software, VR-Planning ©IRCAD2010, offers the opportunity to resect a liver with several topological components allowing thus multi segmentectomy. It then automatically computes the future liver remain rate and volumetry of each resected part.

Validation:

From our results, we have created an online service providing free patient modelling to several associated European clinical teams. First results clearly demonstrate the benefits of the resulting patient-specific surgical planning based on a more precise Future Liver remain volumetry.

From the more than 300 models realized, an open anonymous database of real clinical cases has been created. This database containing medical images in DICOM and 3D models of organs is freely available to the scientific community on PASSPORT's website.

Track record of sharing

PASSPORT project results have been shared to the scientific community through the development of two open source frameworks, one dedicated to computer-assisted surgery (FW4SPL) and one for real-time surgical simulation (SOFA).  Moreover, the PASSPORT project has opened a free access to anonymous patient databases integrating medical images, their associated 3D modelling and also intraoperative video illustrating the use of software (freely available on www.websurg.com/softwares). The extension of PASSPORT results to other specialities is thus open and several examples of such applications have been successfully realized in pancreatic surgery, spleen surgery, colorectal surgery, endocrine surgery and paediatric surgery.

Lessons learnt

"The anatomy has to be based on ontology": The modern anatomy that has been described and used for five centuries is based on the comparison with an average anatomy extracted from living human or having lived. All patients being different, such a definition leads to mistakes or approximations that are called exceptions. In liver anatomy, these "exceptions" represent 60% of cases. The PASSPORT project clearly demonstrates that replacing such a definition of the anatomy by labelling rules applied to each patient modelled in 3D from their medical image, allows the correction of such mistakes. Couinaud's anatomy of the liver defined in 1957 will thus have to be replaced by the resulting new definition, allowing to avoid diagnostic mistakes and to improve surgical eligibility.

"Preoperative patient-specific modelling is mandatory in liver surgery": Eligibility and definition of a hepatic surgical procedure have to be defined from patient-specific modelling of the patient including geometry, topology, mechanics, biology and functionality. Without such modelling, approximation is too important and can lead to a wrong estimation of the optimal therapy to apply.

"Surgeons are not only waiting for preoperative assistance but also for an intraoperative one":  Augmented reality consists in the superimposition of preoperative data on the live intraoperative vision of the patient. The resulting virtual transparency can be used to guide the surgeon intraoperatively. Such guidance is one of the biggest dreams of surgeons who wait for such an improvement of results. Future European projects will have to target such a problem, since it is today not available for surgery on soft tissues due to many limitations. 

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