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As nonalcoholic fatty liver disease (NAFLD) is becoming a leading cause of chronic liver disease, non-invasive diagnosis of disease severity in NAFLD is urgently needed. In this study, the investigators compared hepatic fibrosis and steatosis using MR imaging and transient elastography (TE) and tried to find non-invasive diagnostic marker for NASH and advanced fibrosis.
This is a multicenter prospective study of patients with biopsy-proven NAFLD. The patients were underwent laboratory test, liver biopsy, MRI and TE within 6 months of enrollment. MRI examination included MR spectroscopy (MRS), and MR elastography (MRE). TE measured liver stiffness and controlled attenuation parameter (CAP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biopsy proven NAFLD patients | Experimental | 150 subjects who are diagnosed with NAFLD with biopsy from September 2016 to October 2018. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imaging and serologic evaluation of fibrosis and steatosis | Diagnostic Test | Imaging evaluation: Fibroscan, MRI scan for evaluation of fibrosis and steatosis in biopsy proven NAFLD patients Serologic evaluation: serologic test for evaluation of fibrosis and steatosis in biopsy proven NAFLD patients |
| Measure | Description | Time Frame |
|---|---|---|
| Development of scoring system for diagnosis of NASH | Development of scoring system for diagnosis of NASH using cox regression analysis | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of hepatic fibrosis using fibroscan | Assessment of hepatic fibrosis using fibroscan with transient elastography (kilopascals) (kPa) | up to 24 months |
| Evaluation of hepatic steatosis using fibroscan |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jong Eun Yeon, MD, Ph.D. | Contact | 82-2-2626-3010 | jeyyeon@hotmail.com | |
| Young Sun Lee, MD | Contact | 82-2-2626-3013 | lys810@hanmail.net |
| Name | Affiliation | Role |
|---|---|---|
| Jong Eun Yeon, MD, Ph.D. | Prefessor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Recruiting | Seoul | 08308 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22488764 | Background | Chalasani N, Younossi Z, Lavine JE, Diehl AM, Brunt EM, Cusi K, Charlton M, Sanyal AJ. The diagnosis and management of non-alcoholic fatty liver disease: practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. Hepatology. 2012 Jun;55(6):2005-23. doi: 10.1002/hep.25762. No abstract available. | |
| 22343514 |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
Assessment of hepatic steatosis using fibroscan with CAP (Controlled Attenuation Parameter) (dB/m)
| up to 24 months |
| Evaluation of hepatic fibrosis using MRI | Assessment of hepatic fibrosis using MRI with MR elastography (MRE) (kPa) | up to 24 months |
| Evaluation of hepatic steatosis using MRS | Assessment of hepatic steatosis using fibroscan with MR spectrography (MRS) (%) | up to 24 months |
| Evaluation of hepatic fibrosis using serologic marker | Assessment of hepatic fibrosis using AST to Platelet Ratio Index (APRI) | up to 24 months |
| Background |
| Poynard T, Lenaour G, Vaillant JC, Capron F, Munteanu M, Eyraud D, Ngo Y, M'Kada H, Ratziu V, Hannoun L, Charlotte F. Liver biopsy analysis has a low level of performance for diagnosis of intermediate stages of fibrosis. Clin Gastroenterol Hepatol. 2012 Jun;10(6):657-63.e7. doi: 10.1016/j.cgh.2012.01.023. Epub 2012 Feb 14. |
| 24036007 | Background | Banerjee R, Pavlides M, Tunnicliffe EM, Piechnik SK, Sarania N, Philips R, Collier JD, Booth JC, Schneider JE, Wang LM, Delaney DW, Fleming KA, Robson MD, Barnes E, Neubauer S. Multiparametric magnetic resonance for the non-invasive diagnosis of liver disease. J Hepatol. 2014 Jan;60(1):69-77. doi: 10.1016/j.jhep.2013.09.002. Epub 2013 Sep 12. |
| 24853467 | Background | Park YS, Lee CH, Kim JH, Kim BH, Kim JH, Kim KA, Park CM. Effect of Gd-EOB-DTPA on hepatic fat quantification using high-speed T2-corrected multi-echo acquisition in (1)H MR spectroscopy. Magn Reson Imaging. 2014 Sep;32(7):886-90. doi: 10.1016/j.mri.2014.04.010. Epub 2014 Apr 24. |
| 7560864 | Background | Ishak K, Baptista A, Bianchi L, Callea F, De Groote J, Gudat F, Denk H, Desmet V, Korb G, MacSween RN, et al. Histological grading and staging of chronic hepatitis. J Hepatol. 1995 Jun;22(6):696-9. doi: 10.1016/0168-8278(95)80226-6. No abstract available. |
| 10484010 | Background | Brunt EM, Janney CG, Di Bisceglie AM, Neuschwander-Tetri BA, Bacon BR. Nonalcoholic steatohepatitis: a proposal for grading and staging the histological lesions. Am J Gastroenterol. 1999 Sep;94(9):2467-74. doi: 10.1111/j.1572-0241.1999.01377.x. |
| 14498313 | Background | SCHEUER PJ, WILLIAMS R, MUIR AR. Hepatic pathology in relatives of patients with haemochromatosis. J Pathol Bacteriol. 1962 Jul;84:53-64. No abstract available. |
| 15915461 | Background | Kleiner DE, Brunt EM, Van Natta M, Behling C, Contos MJ, Cummings OW, Ferrell LD, Liu YC, Torbenson MS, Unalp-Arida A, Yeh M, McCullough AJ, Sanyal AJ; Nonalcoholic Steatohepatitis Clinical Research Network. Design and validation of a histological scoring system for nonalcoholic fatty liver disease. Hepatology. 2005 Jun;41(6):1313-21. doi: 10.1002/hep.20701. |
| 21092095 | Background | Piechnik SK, Ferreira VM, Dall'Armellina E, Cochlin LE, Greiser A, Neubauer S, Robson MD. Shortened Modified Look-Locker Inversion recovery (ShMOLLI) for clinical myocardial T1-mapping at 1.5 and 3 T within a 9 heartbeat breathhold. J Cardiovasc Magn Reson. 2010 Nov 19;12(1):69. doi: 10.1186/1532-429X-12-69. |