Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Discontinued by Amra Medical due to funding.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Amra Medical AB | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The aim of this study is to determine the effects of liver transplantation and standard immunosuppression on body composition in patients with compensated cirrhosis and hepatocellular carcinoma.
The combination of hepatocellular carcinoma and chronic liver disease represents a dual impact on overall metabolism. The major risk factors for chronic liver disease related-hepatocellular carcinoma (HCC) include nonalcoholic fatty liver disease (NAFLD), alcoholic liver disease and hepatitis C virus (HCV), among other etiologies of chronic liver injury.
Of particular interest is how the changing landscape of liver disease impacts the care of patients in the peritransplant period. Numerous recent studies have reported that nonalcoholic steatohepatitis (NASH)-related cirrhosis is the most rapidly growing indication for liver transplantation (LT) in the Western world. NAFLD related HCC is already a leading indication in women. The impact of NAFLD on public health and mortality is substantial: incident decompensated cirrhosis due to NAFLD is predicted to increase by 168%, from 39,230 cases annually in 2015 to 105,430 cases in 2030. The corresponding burden of NAFLD cirrhosis on liver transplantation (LT) is expected to increase by 59%. Finally, 3% per year of cirrhotic patients because of NAFLD, develop HCC and noncirrhotic NAFLD-HCC continues to be an area of investigation.
Since NAFLD is becoming one of the most frequent causes of cirrhosis, HCC, and liver transplantation worldwide, it is crucial to identify changes in the peritransplant period that are associated with adverse muscle health and unfavorable metabolic status in the context of all chronic liver diseases.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective Cohort | Chart review will be performed for patients who consent to inclusion in the study. Information from routine care will be reviewed and body composition assessment will be done by routine MRI with an additional 6-8 minute scan using AMRA® Profiler 4 Muscle Assessment Score (MAsS) by performing volumetric quantification of fat and water images acquired with 2-point Dixon magnetic resonance imaging (MRI). |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean muscle volume | Muscle volume will be collected using body composition MR image acquisition that adds about 6-8 minutes acquisition time to the clinically prescribed MRI examination. | Baseline (0-12 months prior to transplant), Day 180 (post-transplant), 1 year (post-transplant) |
| Change in mean muscle fat | Muscle fat will be collected using body composition MR image acquisition adds about 6-8 minutes acquisition time to the clinically prescribed MRI examination | Baseline (0-12 months prior to transplant), Day 180 (post-transplant), 1 year (post-transplant) |
| Measure | Description | Time Frame |
|---|---|---|
| Survival Rate | The percentage of people that are still alive at each time point post transplant compare to 89% average survival rate | Day 90, Day 180, 1 year |
| Number of participants that dropped out of study |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients Undergoing Liver Transplantation for Hepatocellular Carcinoma at risk of nonalcoholic fatty liver disease (NAFLD), alcoholic liver disease and hepatitis C virus (HCV), among other etiologies of chronic liver injury
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Julia Wattacheril, MD | Columbia University Irving Medical Center/ New York Presbyterian hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28961576 | Background | Doycheva I, Issa D, Watt KD, Lopez R, Rifai G, Alkhouri N. Nonalcoholic Steatohepatitis is the Most Rapidly Increasing Indication for Liver Transplantation in Young Adults in the United States. J Clin Gastroenterol. 2018 Apr;52(4):339-346. doi: 10.1097/MCG.0000000000000925. | |
| 25461851 | Background | Wong RJ, Aguilar M, Cheung R, Perumpail RB, Harrison SA, Younossi ZM, Ahmed A. Nonalcoholic steatohepatitis is the second leading etiology of liver disease among adults awaiting liver transplantation in the United States. Gastroenterology. 2015 Mar;148(3):547-55. doi: 10.1053/j.gastro.2014.11.039. Epub 2014 Nov 25. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D006528 | Carcinoma, Hepatocellular |
| D008107 | Liver Diseases |
| D008113 | Liver Neoplasms |
| D008103 | Liver Cirrhosis |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D004066 | Digestive System Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
Not provided
Not provided
Not provided
Not provided
Not provided
This is to measure how many participants did not complete the study for any cause
| 1 year |
| MRI-proton density fat fraction (MRI-PDFF) | This is to measure/assess intrahepatic fat (IHF) using body composition MR image acquisition adds about 6-8 minutes acquisition time to the clinically prescribed MRI examination | Baseline (0-12 months prior to transplant), Day 180 (post-transplant), 1 year (post-transplant) |
| Visceral adipose tissue volume | Visceral adipose tissue volume will be collected using body composition MR image acquisition adds about 6-8 minutes acquisition time to the clinically prescribed MRI examination | 1 year |
| Abdominal subcutaneous adipose tissue volume | Abdominal subcutaneous adipose tissue volume will be collected using body composition MR image acquisition adds about 6-8 minutes acquisition time to the clinically prescribed MRI examination | 1 year |
| Delta HOMA-IR | Delta homeostasis model assessment of insulin resistance (HOMA-IR) will be assessed using plasma glucose, insulin | 1 year |
| 28744836 | Background | Cholankeril G, Wong RJ, Hu M, Perumpail RB, Yoo ER, Puri P, Younossi ZM, Harrison SA, Ahmed A. Liver Transplantation for Nonalcoholic Steatohepatitis in the US: Temporal Trends and Outcomes. Dig Dis Sci. 2017 Oct;62(10):2915-2922. doi: 10.1007/s10620-017-4684-x. Epub 2017 Jul 25. |
| 28833326 | Background | Parikh ND, Marrero WJ, Wang J, Steuer J, Tapper EB, Konerman M, Singal AG, Hutton DW, Byon E, Lavieri MS. Projected increase in obesity and non-alcoholic-steatohepatitis-related liver transplantation waitlist additions in the United States. Hepatology. 2019 Aug;70(2):487-495. doi: 10.1002/hep.29473. Epub 2018 May 14. |
| 28802062 | Background | Estes C, Razavi H, Loomba R, Younossi Z, Sanyal AJ. Modeling the epidemic of nonalcoholic fatty liver disease demonstrates an exponential increase in burden of disease. Hepatology. 2018 Jan;67(1):123-133. doi: 10.1002/hep.29466. Epub 2017 Dec 1. |
| 29785727 | Background | Linge J, Borga M, West J, Tuthill T, Miller MR, Dumitriu A, Thomas EL, Romu T, Tunon P, Bell JD, Dahlqvist Leinhard O. Body Composition Profiling in the UK Biobank Imaging Study. Obesity (Silver Spring). 2018 Nov;26(11):1785-1795. doi: 10.1002/oby.22210. Epub 2018 May 22. |
| 33598647 | Background | Linge J, Ekstedt M, Dahlqvist Leinhard O. Adverse muscle composition is linked to poor functional performance and metabolic comorbidities in NAFLD. JHEP Rep. 2020 Oct 28;3(1):100197. doi: 10.1016/j.jhepr.2020.100197. eCollection 2021 Feb. |
| 31642894 | Background | Linge J, Heymsfield SB, Dahlqvist Leinhard O. On the Definition of Sarcopenia in the Presence of Aging and Obesity-Initial Results from UK Biobank. J Gerontol A Biol Sci Med Sci. 2020 Jun 18;75(7):1309-1316. doi: 10.1093/gerona/glz229. |
| 26768490 | Background | Borga M, Thomas EL, Romu T, Rosander J, Fitzpatrick J, Dahlqvist Leinhard O, Bell JD. Validation of a fast method for quantification of intra-abdominal and subcutaneous adipose tissue for large-scale human studies. NMR Biomed. 2015 Dec;28(12):1747-53. doi: 10.1002/nbm.3432. Epub 2015 Nov 2. |
| 29415060 | Background | West J, Romu T, Thorell S, Lindblom H, Berin E, Holm AS, Astrand LL, Karlsson A, Borga M, Hammar M, Leinhard OD. Precision of MRI-based body composition measurements of postmenopausal women. PLoS One. 2018 Feb 7;13(2):e0192495. doi: 10.1371/journal.pone.0192495. eCollection 2018. |
| 27662190 | Background | West J, Dahlqvist Leinhard O, Romu T, Collins R, Garratt S, Bell JD, Borga M, Thomas L. Feasibility of MR-Based Body Composition Analysis in Large Scale Population Studies. PLoS One. 2016 Sep 23;11(9):e0163332. doi: 10.1371/journal.pone.0163332. eCollection 2016. |
| 25111561 | Background | Karlsson A, Rosander J, Romu T, Tallberg J, Gronqvist A, Borga M, Dahlqvist Leinhard O. Automatic and quantitative assessment of regional muscle volume by multi-atlas segmentation using whole-body water-fat MRI. J Magn Reson Imaging. 2015 Jun;41(6):1558-69. doi: 10.1002/jmri.24726. Epub 2014 Aug 11. |
| 31013363 | Background | Ajmera VH, Cachay E, Ramers C, Vodkin I, Bassirian S, Singh S, Mangla N, Bettencourt R, Aldous JL, Park D, Lee D, Blanchard J, Mamidipalli A, Boehringer A, Aslam S, Leinhard OD, Richards L, Sirlin C, Loomba R. MRI Assessment of Treatment Response in HIV-associated NAFLD: A Randomized Trial of a Stearoyl-Coenzyme-A-Desaturase-1 Inhibitor (ARRIVE Trial). Hepatology. 2019 Nov;70(5):1531-1545. doi: 10.1002/hep.30674. Epub 2019 Jun 18. |
| 28278002 | Background | Middleton MS, Haufe W, Hooker J, Borga M, Dahlqvist Leinhard O, Romu T, Tunon P, Hamilton G, Wolfson T, Gamst A, Loomba R, Sirlin CB. Quantifying Abdominal Adipose Tissue and Thigh Muscle Volume and Hepatic Proton Density Fat Fraction: Repeatability and Accuracy of an MR Imaging-based, Semiautomated Analysis Method. Radiology. 2017 May;283(2):438-449. doi: 10.1148/radiol.2017160606. Epub 2017 Mar 9. |
| D009375 |
| Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |