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Project title

Non-invasive assessment of non-alcoholic steatohepatitis through unidimensional transient elastography, „ShearWave” elastography and serum markers. (Acronim ELASTOLIVER)

 

Evaluarea neinvaziva a steatohepatitei nonalcoolice prin elastografie tranzitorie unidimensionala, elastografie „ShearWave” si markeri serici)

 

Project Acronym

ELASTOLIVER

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Source of funding

A grant of the Romanian National Authority for Scientific Research and Innovation, CNCS – UEFISCDI.

 

Project code

PN-II-RU-TE-2014-4-2023

 

Contract number

365 /  01.10.2015

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Project director

Monica Platon (Lupsor) MD, PhD

Associate Professor, Department of Medical Imaging, Prof. Dr. Octavian Fodor Regional Institute of Gastroenterology and Hepatology, Iuliu Hațieganu University of Medicine and Pharmacy Cluj-Napoca,

Email: monica.lupsor@umfcluj.ro

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Research Team

 

  1. Platon (Lupsor) Monica - project director

  2. Stefanescu Horia

  3. Suciu   Alina

  4. Gersak Mariana Mirela 

  5. Maniu Anca Cristina

  6. Urs Gavril Radu

  7. Al Hajjar Nadim

  8. Rusu Ioana

  9. Vicas Cristian Marian

 

Project description

 

Abstract. Non-alcoholic fatty liver disease (NAFLD) is currently the most common chronic liver disease worldwide; it includes a wide spectrum of conditions, ranging from a simple fatty liver to non-alcoholic steatohepatitis (NASH) with or without fibrosis, to cirrhosis and hepatocellular carcinoma. The diagnosis of NAFLD, and mainly of NASH, requires a liver biopsy, but it has some limits. More research is focused on finding alternative non-invasive methods of diagnosis. Our major objective is to develop a non-invasive diagnostic algorithm for NASH, by combining unidimensional transient elastography including the liver stiffness and controlled attenuation parameter assessment, „shear wave elastography” (SWE) available on the Logiq E9 and Supersonic devices, and serum markers of liver fibrosis. The secondary objectives are estimating the performance of new elastographic techniques (Logiq E9 SWE, Supersonic) for the assessment of fibrosis in NASH in comparison with liver biopsy, interpreted through the computerized analysis of the histologic image, establishing the technical criteria to be met for the most accurate possible estimation of fibrosis when using Logiq E9 SWE or Supersonic SWE, evaluating the performance of the controlled attenuation parameter (CAP) measured by TE in assessing the grade of steatosis in NASH, evaluating the performance of certain serum markers in assessing fibrosis in NASH. The study is going to be conducted prospectively, for a duration of 24 months, in at least 100 biopsied patients with diffuse liver diseases.

 

Objectives

 

The major objective; achieving a noninvasive diagnostic algorithm of NASH using combined TE (Fibroscan) (including liver stiffness measurement for fibrosis prediction and controlled attenuation coefficient (CAP) for steatosis prediction), "shear wave elastography" (SWE) available on Logiq E9 and Supersonic equipments and serum markers of liver fibrosis.

Secondary objectives:

  1. Evaluation of a new elastographic method performance (2D-SWE available on Logiq E9 and Supersonic) for assessing fibrosis in NASH compared to liver biopsy interpreted by computer analysis of histological image;

  2. Establishment of technical criteria to be met for a more accurate assessment of fibrosis by 2D-SWE

  3. Evaluation of CAP performance for assessing the degree of steatosis in NASH compared to the  liver biopsy;

  4. Evaluation of serum markers performance for noninvasive fibrosis assessment in NASH

 

Expected results

  1. Achieving a NASH noninvasive diagnostic algorithm using combined TE (Fibroscan), "shear wave elastography" (2D-SWE) and serum markers

  2. Establishing 2D SWE performance  for fibrosis assessment in NASH patients, the technical criteria to be met for a more accurate assessment of fibrosis by SWE, the error factors in interpreting the results, the advantages and limitations of this method

  3. Establishing the elastography performance for fibrosis prediction in NASH when combining two elastographic techniques (TE associated with 2D-SWE) and the usual  serum markers

  4. Establishing CAP performance in assessing the degree of steatosis in NASH.

 

 

Plan of project realization

 

► Phase 1

Setting technical criteria to be met for a more accurate assessment of fibrosis by SWE

Activities:

  1. Finalizing clinical and biochimica and invasive investigation protocols.

  2. Finalization of the database architecture

  3. obtaining the ethics committee statement

  4. Purchasing of materials and supplies

  5. Start recruiting patients and storage of biological materials and elastography data according to the protocols

  6. Report

Results delivered at the end of the phase 1 (december 2015).

  • research report

  • clinical trial protocol

  • database (structure)

 

► Phase 2

 

Objective 2.1. Establish the performance of 2D SWE and unidimensional transient elastography (Fibroscan) to assess fibrosis in NASH and other liver diffuse compared to liver biopsy

Activities:

  1. Recruiting patients and storage of biological materials and elastography data according to the protocols

  2. Purchase materials and supplies

  3. Preliminary statistical analysis of the data obtained

  4. Dissemination of preliminary results

Objective 2.2. Establishing the performance of serum markers for fibrosis and steatosis assessment in NASH and other liver diffuse diseases.

Activities:

  1. Recruiting patients and storage of biological materials and elastography data according to the protocols

  2. Purchase materials and supplies

  3. Preliminary statistical analysis of the data obtained

  4. Dissemination of preliminary results

Obiectiv 2.3. Evaluation of CAP performance for steatosis assessment in NASH and other liver diffuse compared to liver biopsy.

Activities:

  1. Recruiting patients and storage of biological materials and elastography data according to the protocols

  2. Preliminary statistical analysis of the data obtained

  3. Report

 

Results delivered at the end of the phase 2 (december 2016)

  • research report

  • database (completed in a proportion of 60%)

 

► Phase 3

Objective. Achieving a NASH noninvasive diagnostic algorithm using combined TE (Fibroscan), "shear wave elastography" (2D-SWE) and serum markers

Activities

  1. Recruiting patients and storage of biological materials and elastography data according to the protocols

  2. Purchase materials and supplies

  3. The analyze of biochemical, elastographic and morphological data

  4. Statistical analysis of the obtained data

  5. Report and disemination of the results

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Results

The intermediate results obtained were disseminated in the form of articles ISI, oral presentations and posters at various national and international conferences.

 

Chapters in books.

  1. Monica Lupsor-Platon. Non-invasive Evaluation of Fibrosis and Steatosis in Non-alcoholic Fatty Liver Disease by Elastographic Methods. In "Non-Alcoholic Fatty Liver Disease - Molecular Bases, Prevention and Treatment", pg 1-26. Ed Intech 2017, Croatia.. Book edited by Rodrigo Valenzuela Baez, Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.  ISBN 978-953-51-5579-9.

 

Articles

  1. Monica Lupșor-Platon, Radu Badea, Mirela Gersak, Anca Maniu, Ioana Rusu, Alina Suciu, Cristian Vicas, Horia Stefănescu, Radu Urs, Nadim Al Hajjar. Noninvasive Assessment of Liver Diseases using 2D Shear Wave Elastography. J Gastrointestin Liver Dis, December 2016 Vol. 25 No 4. [will be published in the month of December 2016]

Data about the article: ISI, 2015 Impact Factor: 1.891. Five-year Impact Factor: 2.387. Influence score: 0.735. indexed / covered by major information retrieval systems, including Thomson Reuters - Science Citation Index Expanded (SciSearch®) and Journal Citation Reports/Science Edition, Index Medicus and Medline/Pubmed, EMBASE/Excerpta Medica, SCOPUS, EBSCO, DOI/Crossref and Google Scholar. ISSN print: 1841-8724; ISSN on-line: 1842-1121. DOI: 10.15403

  1. Mariana M. Gersak, Monica Lupșor-Platon, Radu Badea, Anca Ciurea, Sorin M. Dudea. Strain Elastography (SE) for liver fibrosis estimation – which elastic score to calculate? Med Ultrason 2016, Vol. 18, no. 4, 481-487

(Corresponding author: Monica Lupșor-Platon)

Data about the article. Journal Indexing: ISI, Impact Factor: 1.167 (JCR 2015), SJR (2015) : 0.401, IPP (2015): 1.414, SNIP (2015) : 0.917; indexed / covered by major information retrieval systems: Medline/PubMed, Scopus, CrossRef, EBSCO,

ISSN 2066-8643

  1. Cristian Vicas, Ioana Rusu, Nadim Al Hajjar, Monica Lupșor-Platon. Deep convolutional neural nets for objective steatosis detection from liver samples. Proceeding of 2017 13th IEEE International Conference on Intelligent Computer Communication and Processing (ICCP) 2017: 385 – 390 (indexat EEE Xplore Digital Library, Scopus)

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Oral papers from the project, presented at various conferences

  1. Platon Lupsor Monica. Elastografia. Principii. Conferinta sustinuta la Workshopul SonoMed „Actualități în ultrasonografie”, 24 noiembrie 2017, Baia Mare, Romania

  2. Platon Lupsor Monica. Rolul elastografiei în abordarea pacienților cu afecțiuni tumorale abdominale. Conferință susținută la Conferința “Abordarea multidisciplinară a pacientului cu afecțiuni tumorale” desfășurată la Targu Mures, 17-18 noiembrie 2017

  3. Platon Lupsor Monica. Elastografia hepatică. Conferință susținută în cadrul mesei rotunde “Actualități în elastografia ultrasonoră” organizată în cadrul Congresului Național de Radiolgie și Imagistică Medicală, București, 6-8 oct 2017

  4. Platon Lupsor Monica Elastografia. Principii. Conferinta sustinuta la Simpozionul “Actualitati in ultrasonografie – Sonomed”, 30 sept 2017, Zalau.

  5. Monica Platon lupsor. Evaluarea neinvaziva a fibrozei si steatozei in afectiunile hepatice difuze prin elastografie tranzitorie unidimensionala.  Conferinta sustinuta in cadrul mesei rotunde “Elastografia organelor abdominale” organizata cu ocazia celei de-la “XX-a conferinţă naţională a societății române de ultrasonografie în medicină şi biologie”, Cluj-Napoca, 1-3 iunie 2017

  6. Muntean DD, Maniu A, Rusu I, Stefanescu H, Al Hajjar N, Lupsor-Platon M. Noninvasive assessment of liver stiffness in healthy subjects using supersonic shear wave elastography. Lucrare prezentata in sectiunea “Cele mai bune lucrari stiintifice originale” organizata cu ocazia celei de-la “XX-a conferinţă naţională a societății române de ultrasonografie în medicină şi biologie”, Cluj-Napoca, 1-3 iunie 2017

  7. Monica Platon Lupsor. Non-invasive evaluation of fibrosis and steatosis by elastographic methods in fatty liver disease. Conferinta sustinuta in cadrul mesei rotunde “Alcoholic and non-alcoholic liver disease” organizata cu ocazia celui de-al 37-lea Congres Naţional de Gastroenterologie, Hepatologie şi Endoscopie Digestivă, 22-24 iunie 2017, Bucureşti

  8. Monica Platon Lupşor. Elastografia ficatului. Tehnici existente. Ce alegem? Cum alegem? Cum interpretăm? Valoare diagnostică adăugată. Conferinta sustinuta la Simpozionul „Ultrasonografia – aplicaţii moderne în gastroenterologie şi oncologie” organizat cu ocazia  Conferintei Naţionale Medicina bazată pe dovezi. Editia XIII. 3-5 noiembrie 2016, Brașov, România

  9. Monica Platon Lupşor. Rolul elastografiei in evaluarea neinvazivă a patologiei abdominale. Prezentare susţinută la Conferinţa „Abordarea multidisciplinară a pacientului, cheia succesului terapeutic. Targu-Mureş, 30 sept-1 oct 2016

  10. Monica Platon Lupșor. Capcane tehnice și de interpretare în elastografia hepatică. Conferinta sustinuta in cadrul mesei rotunde „Noutăți în elastografie” organizată cu ocazia celei de-a XIX-a Conferinţă Naţională de Ultrasonografie cu participare internaţională, 23-25 iunie 2016, Craiova

  11. Monica Lupsor-Platon, Radu Badea, Ioana Rusu, Radu Urs, Olga Orăsan, Alina Suciu, Horia Stefănescu, Anca Maniu, Mirela Gersak, Cristian Vicaș, Nadim Al Hajjar „Performanța diagnostică a elastografiei „shear-wave” (Supersonic) pentru predicția neinvazivă a fibrozei în hepatopatiile difuze. Rezultate preliminare”. Lucrarea a fost prezentată la a XIX-a Conferinţă Naţională de Ultrasonografie cu participare internaţională, 23-25 iunie 2016, Craiova

  12. Monica Platon Lupșor. „Rolul elastografiei hepatice”.  Conferinta sustinuta in cadrul mesei rotunde „Diagnosticul invaziv și neinvaziv al hipertensiunii portale” organizată cu ocazia celui de-al XXXVI-lea Congres Naţional de Gastroenetrologie, Hepatologie şi Endoscopie Digestivă, Cluj-Napoca, 8-10 iunie 2016

  13. Monica Platon Lupșor. Non-invasive follow-up of liver fibrosis. Conferinţă susţinuta la UEG Course - Update in chronic digestive diseases: What is changing, what is challenging?, organizată cu ocazia celui de-al XXXVI-lea Congres Naţional de Gastroenetrologie, Hepatologie şi Endoscopie Digestivă, Cluj-Napoca, 8-10 iunie 2016

  14. Monica Platon Lupșor, Horia Ștefănescu. Elastografia în evaluarea neinvazivă a afecțiunilor hepatice. Tehnici, informații specifice, limite. Conferinţă susţinuta în sesiunea demo ecografie - Aplicații ale ultrasonografiei în hepatologie și gastroenterologie: examinarea cu contrast si elastografia, organizată cu ocazia celui de-al XXXVI-lea Congres Naţional de Gastroenetrologie, Hepatologie şi Endoscopie Digestivă, Cluj-Napoca, 8-10 iunie 2016

  15. Monica Platon Lupșor, Horia Ștefănescu. Elastografia în afecțiunile ficatului. Cum se efectuează în mod practic? Demonstrații pe diferite tipuri de echipamente elastografice. Conferinţă susţinuta în sesiunea demo ecografie - Aplicații ale ultrasonografiei în hepatologie și gastroenterologie: examinarea cu contrast si elastografia, organizată cu ocazia celui de-al XXXVI-lea Congres Naţional de Gastroenetrologie, Hepatologie şi Endoscopie Digestivă, Cluj-Napoca, 8-10 iunie 2016

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Papers published in abstract volume

 

  1. Cristian Vicas, Ioana Rusu, Nadim Al Hajjar, Monica Lupșor-Platon. Deep convolutional neural nets for objective steatosis detection from liver samples. Proceeding of 2017 13th IEEE International Conference on Intelligent Computer Communication and Processing (ICCP) 2017: 385 – 390 (indexat EEE Xplore Digital Library, Scopus)

  2. Monica Lupsor-Platon, Radu Badea, Ioana Rusu, Radu Urs, Olga Orăsan, Alina Suciu, Horia Stefănescu, Anca Maniu, Mirela Gersak, Cristian Vicaș, Nadim Al Hajjar. Performanța diagnostică a elastografiei „shear-wave” (Supersonic) pentru predicția neinvazivă a fibrozei în hepatopatiile difuze. Rezultate preliminare. Volumul de rezumate al celei de-a XIX-a Conferinţe Naţionale de Ultrasonografie cu participare internaţională, 23-25 iunie 2016, Craiova, pg 23-24, Ed Medicală Universitară, Craiova 2016 (ISBN 978-973-106-272-3)

  3. Monica Lupsor-Platon. Capcane tehnice și de interpretare în elastografia hepatică. Volumul de reazumate al celei de-a XIX-a Conferinţe Naţionale de Ultrasonografie cu participare internaţională, 23-25 iunie 2016, Craiova, pg 106-107, Ed Medicală Universitară, Craiova 2016 (ISBN 978-973-106-272-3)

 

Papers presented in poster section in various conferences

  1. Munteanu DD, Maniu A, Rusu I, Stefanescu H, Al Hajjar N, Lupsor-Platon M. Liver fibrosis assessement in paients with diffuse liver disease using supersonic shear wave elastography. Lucrare prezentata in sectiunea poster cu ocazia celei de-a “XX-a conferinţe naţionale a societății române de ultrasonografie în medicină şi biologie, Cluj-Napoca, 1-3 iunie 2017

  2. M. Lupsor-Platon, R. Badea, A. Maniu, I. Rusu, H. Stefanescu, C. Vicas, M. Gersak, R. Urs, N. Al Hajjar. Logiq E9 real-time shear-wave elastography for noninvasive assessment of liver fibrosis in diffuse liver diseases patients (C-0553). Doi: 10.1594/ecr2017/C-0553 (lucrare prezentata in sectiunea poster electronic la 29th EUROPEAN CONGRESS OF RADIOLOGY – ECR 2017), 1-5 martie 2017, Viena

  3. M. Lupsor-Platon, R. Badea, A. Maniu, I. Rusu, H. Stefanescu, C. Vicas, M. Gersak, R. Urs, N. Al Hajjar Transient elastography for noninvasive assessment of liver fibrosis in nonalcoholic steatohepatitis patients (C-0373). Doi: 10.1594/ecr2017/C-0373. (lucrare prezentata in sectiunea poster electronic la 29th EUROPEAN CONGRESS OF RADIOLOGY – ECR 2017), 1-5 martie 2017, Viena

  4. M. Lupsor-Platon, R. Badea, A. Maniu, A. Suciu, I. Rusu, H. Stefanescu, R. Urs, N. Al Hajjar. The diagnosis performance of real-time shear-wave elastography for noninvasive assessment of liver fibrosis in diffuse liver diseases patients. Preliminary results. Lucrare prezentata in sectiunea „electronic poster”  within the scientific and educational programme at the European Congress of Radiology 2016, held March 2-6, 2016, in Vienna, Austria (C-2416)

  5. M. Lupsor-Platon, R. Badea, A. Maniu, H. Stefanescu, A. Suciu, I. Rusu, R. Urs, N. Al Hajjar. C-2417 - The diagnosis performance of real-time shear-wave elastography for noninvasive assessment of esophageal varices in liver cirrhosis. Preliminary results. Lucrare prezentata in sectiunea „electronic poster”  within the scientific and educational programme at the European Congress of Radiology 2016, held March 2-6, 2016, in Vienna, Austria (C-2417)

 

Accepted papers for presentation in electronic poster section at European Congress of Radiology 2018, Vienna, Austria

  1. Monica Lupsor-Platon, Anca Maniu, Ioana Rusu, Horia Stefanescu, Nadim Al Hajjar. ‘Noninvasive elastographic assessment of liver steatosis using controlled attenuation parameter. Results from a cohort of 401 biopsied chronic liver diseases patients. Lucrare  acceptata pt prezentare in sectiunea poster electronic la European Congress of Radiology, February 28 – March 4, 2018

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Works submitted for review

  1. Alina Giurgiu, Cristian Vicas, Ioana Rusu, Horia Stefanescu, Nadim Al Hajjar, Monica Lupsor-Platon. Could computer analysis become the new standard for Transient Elastography in assessing liver fibrosis and steatosis in diffuse liver disease? Lucrare trimisa pentru jurizare la European Congress of Radiology, February 28 – March 4, 2018

  2. Monica Lupsor-Platon,  Alina Giurgiu, Anca Maniu, Cristian Vicas, Ioana Rusu, Horia Stefanescu, Nadim Al Hajjar. Correlation between CAP and steatosis percent objectively quantified from the entire liver biopsy specimen using  a computer analysis tool.Llucrare trimisa pentru jurizare la European Congress of Radiology, February 28 – March 4, 2018

  3. Monica Lupsor-Platon, Anca Maniu, Ioana Rusu, Horia Stefanescu, Alina Suciu, Radu Urs, Nadim Al Hajjar Noninvasive elastographic assessment of liver steatosis using controlled attenuation parameter. Results from a cohort of  401 biopsied chronic liver diseases patients – lucrare trimisa pentru jurizare la „The International Liver Congress EASL 2018, Paris, Franta, 11- 15 April, 2018

  4. Monica Lupsor-Platon,  Alina Giurgiu, Anca Maniu, Cristian Vicas, Ioana Rusu, Horia Stefanescu, Radu Urs, Nadim Al Hajjar. Correlation between controlled attenuation parameter assessed with Fibroscan and steatosis percent objectively quantified from the entire liver biopsy specimen using a computer analysis tool. Preliminary results. – lucrare trimisa pentru jurizare la „The International Liver Congress EASL 2018, Paris, Franta, 11- 15 April, 2018

 

Awards

  1. Monica Lupsor-Platon. Award for best original scientific paper „Performanța diagnostică a elastografiei „shear-wave” (Supersonic) pentru predicția neinvazivă a fibrozei în hepatopatiile difuze. Rezultate preliminare”.

This work was presented at the XIX National Conference of Ultrasonography with international participation, 23 to 25 June 2016, Craiova

Authors: Monica Lupsor-Platon, Radu Badea, Ioana Rusu, Radu Urs, Olga Orăsan, Alina Suciu, Horia Stefănescu, Anca Maniu, Mirela Gersak, Cristian Vicaș, Nadim Al Hajjar.

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