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Grant Details

Grant Number: 5R01CA212008-06 Interpret this number
Primary Investigator: Singal, Amit
Organization: Ut Southwestern Medical Center
Project Title: Harms of Hepatocellular Carcinoma Screening in Patients with Cirrhosis
Fiscal Year: 2022


Abstract

PROJECT SUMMARY / ABSTRACT The incidence of hepatocellular carcinoma (HCC) is rising in the U.S and is projected to become the 3rd leading cause of cancer death by 2030. Over 90% of HCC occur in cirrhosis, and HCC is the leading cause of death for these patients. Although several professional societies recommend use of abdominal ultrasound and alpha fetoprotein (AFP), a serum biomarker, every 6 months in patients with cirrhosis, limitations in the literature have precluded consensus recommendations. Two systematic reviews concluded prior studies have notable limitations including a lack of data regarding screening harms. Potential harms of HCC screening include: 1) physical and financial harms from diagnostic evaluation in screen-positive patients (e.g., contrast injury, radiation exposure, biopsy complications); 2) overdiagnosis; and 3) psychosocial harms due to positive or indeterminate screen results. Because the survival benefit of HCC screening appears modest, a comprehensive harms assessment is needed to inform guidelines, build consensus among primary care providers and specialists, and guide patient and provider decision-making about HCC screening. Leveraging a multi-center randomized trial assessing screening benefits in a socioeconomically (~30% underinsured) and racially diverse (>50% Black or Hispanic) population of 3000 patients with cirrhosis followed in 3 healthcare settings (academic tertiary care center, safety-net health system, and Veterans Affairs system) over a 4-year period, we propose to: Aim 1: Assess the effect of HCC screening on a) physical harms due to follow-up tests, b) financial harms, and c) overdiagnosis in patients with severe liver dysfunction or comorbid illness, through electronic medical record data, manual chart review, and validated survey measures Aim 2: Assess the effect of HCC screening on screening-related psychosocial harms, e.g. cancer-specific worry, situational anxiety, mood disturbances, and decisional regret, through longitudinal validated measures and qualitative interviews Aim 3: Create and disseminate a balance sheet of benefits and harms to inform patients, nurses, providers, healthcare organizations, payers, and policymakers about the value of HCC screening in patients with cirrhosis We will use mixed-effect regression analysis to identify if screening-related harms differ by patient, provider, and healthcare system factors. These data will complement concurrently collected data about screening benefits from the randomized trial to provide the highest quality data available about benefits and harms of HCC screening at a time when policy decisions about HCC screening are being made. We will immediately translate our study findings to facilitate patient-provider discussions, inform payer decisions about reimbursement, and guide policy decisions on HCC screening in patients with cirrhosis.



Publications

Cost-effectiveness of an outreach program for HCC screening in patients with cirrhosis: a microsimulation modeling study.
Authors: Gurley T. , Hernaez R. , Cerda V. , Thomas T. , Narasimman M. , Mittal S. , Al-Hasan M. , Daher D. , Singal A.G. .
Source: Eclinicalmedicine, 2025 Mar; 81, p. 103113.
EPub date: 2025-02-17 00:00:00.0.
PMID: 40040860
Related Citations

Benefits and harms of hepatocellular carcinoma screening outreach in patients with cirrhosis: a multicenter randomized clinical trial.
Authors: Singal A.G. , Daher D. , Narasimman M. , Yekkaluri S. , Liu Y. , Cerda V. , Banala C. , Khan A. , Lee M. , Seif El Dahan K. , et al. .
Source: Journal Of The National Cancer Institute, 2025-02-01 00:00:00.0; 117(2), p. 262-269.
PMID: 39288308
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Effectiveness of mailed outreach and patient navigation to promote HCC screening process completion: a multicentre pragmatic randomised clinical trial.
Authors: Singal A.G. , Narasimman M. , Daher D. , Yekkaluri S. , Liu Y. , Lee M. , Cerda V. , Khan A. , Seif El Dahan K. , Kramer J. , et al. .
Source: Gut, 2024-11-11 00:00:00.0; 73(12), p. 2037-2044.
EPub date: 2024-11-11 00:00:00.0.
PMID: 38839269
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Patients With Cirrhosis Rapidly Review Potentially Abnormal Hepatocellular Carcinoma Surveillance Results Through the Patient Portal.
Authors: Louissaint J. , Kyalwazi B. , Deng J. , Melendez-Torres J. , Turer R.W. , Hogan T.P. , Tapper E.B. , Yekkaluri S. , Xie D. , Rich N.E. , et al. .
Source: The American Journal Of Gastroenterology, 2024-07-03 00:00:00.0; , .
EPub date: 2024-07-03 00:00:00.0.
PMID: 39119809
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Psychiatric disorders in patients with hepatocellular carcinoma: A large US cohort of commercially insured individuals.
Authors: Patel M.J. , Jones A. , Jiang Y. , Gowda P. , VanWagner L.B. , Cotter T.G. , Seif El Dahan K. , Louissaint J. , Patel M. , Rich N.E. , et al. .
Source: Alimentary Pharmacology & Therapeutics, 2024-06-11 00:00:00.0; , .
EPub date: 2024-06-11 00:00:00.0.
PMID: 38863242
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Financial burden in a US cohort of patients with HCC.
Authors: Desai R. , Jiang Y. , VanWagner L.B. , Singal A.G. , Lieber S.R. .
Source: Hepatology Communications, 2024-06-01 00:00:00.0; 8(6), .
EPub date: 2024-06-03 00:00:00.0.
PMID: 38829203
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Proportion of Time Covered by Hepatocellular Carcinoma Surveillance in Patients With Cirrhosis.
Authors: Daher D. , Seif El Dahan K. , Yekkaluri S. , Gopal P. , Rich N.E. , Parikh N.D. , Murphy C.C. , Singal A.G. .
Source: The American Journal Of Gastroenterology, 2024-05-01 00:00:00.0; 119(5), p. 875-882.
EPub date: 2023-11-17 00:00:00.0.
PMID: 37975606
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Hepatocellular Carcinoma Screening in a Contemporary Cohort of At-Risk Patients.
Authors: Daher D. , Seif El Dahan K. , Rich N.E. , Tayob N. , Merrill V. , Huang D.Q. , Yang J.D. , Kulkarni A.V. , Kanwal F. , Marrero J. , et al. .
Source: Jama Network Open, 2024-04-01 00:00:00.0; 7(4), p. e248755.
EPub date: 2024-04-01 00:00:00.0.
PMID: 38683607
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Hepatocellular Carcinoma Surveillance Patterns and Outcomes in Patients With Cirrhosis.
Authors: Daher D. , Seif El Dahan K. , Cano A. , Gonzales M. , Ransom C. , Jaurez E. , Carranza O. , Quirk L. , Morgan T. , Gopal P. , et al. .
Source: Clinical Gastroenterology And Hepatology : The Official Clinical Practice Journal Of The American Gastroenterological Association, 2024 Feb; 22(2), p. 295-304.e2.
EPub date: 2023-08-12 00:00:00.0.
PMID: 37573986
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Hepatocellular carcinoma surveillance may be associated with potential psychological harms in patients with cirrhosis.
Authors: Narasimman M. , Hernaez R. , Cerda V. , Lee M. , Sood A. , Yekkaluri S. , Khan A. , Quirk L. , Liu Y. , Kramer J.R. , et al. .
Source: Hepatology (baltimore, Md.), 2024-01-01 00:00:00.0; 79(1), p. 107-117.
EPub date: 2023-07-04 00:00:00.0.
PMID: 37401857
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COVID-19 Pandemic Impact on Diagnosis, Stage, and Treatment of Hepatocellular Carcinoma in the United States.
Authors: Kaur B. , Yeo Y.H. , Liang J. , Luu M. , Ayoub W. , Kuo A. , Trivedi H. , Sankar K. , Gong J. , Hendifar A. , et al. .
Source: Gastro Hep Advances, 2024; 3(2), p. 230-237.
EPub date: 2023-11-23 00:00:00.0.
PMID: 39129956
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The financial burden after liver transplantation is significant among commercially insured adults: A large US National Cohort.
Authors: Lieber S.R. , Jiang Y. , Jones A.R. , Gowda P. , Ufere N.N. , Patel M.S. , Gurley T. , Noriega Ramirez A. , Ngo V.M. , Olumesi M.C. , et al. .
Source: Liver Transplantation : Official Publication Of The American Association For The Study Of Liver Diseases And The International Liver Transplantation Society, 2023-12-18 00:00:00.0; , .
EPub date: 2023-12-18 00:00:00.0.
PMID: 38108824
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Underuse of HCC Surveillance: Not a Sign of Cynicism.
Authors: Singal A.G. , Daher D. , Seif El Dahan K. , Rich N.E. , Yang J.D. , Parikh N.D. .
Source: Clinical Gastroenterology And Hepatology : The Official Clinical Practice Journal Of The American Gastroenterological Association, 2023-11-17 00:00:00.0; , .
EPub date: 2023-11-17 00:00:00.0.
PMID: 37979666
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Financial Burden of Hepatocellular Carcinoma Screening in Patients with Cirrhosis.
Authors: Narasimman M. , Hernaez R. , Cerda V. , Lee M. , Yekkaluri S. , Khan A. , Sood A. , Gurley T. , Quirk L. , Liu Y. , et al. .
Source: Clinical Gastroenterology And Hepatology : The Official Clinical Practice Journal Of The American Gastroenterological Association, 2023-08-05 00:00:00.0; , .
EPub date: 2023-08-05 00:00:00.0.
PMID: 37544418
Related Citations

International Liver Cancer Association (ILCA) white paper on hepatocellular carcinoma risk stratification and surveillance.
Authors: Singal A.G. , Sanduzzi-Zamparelli M. , Nahon P. , Ronot M. , Hoshida Y. , Rich N. , Reig M. , Vilgrain V. , Marrero J. , Llovet J.M. , et al. .
Source: Journal Of Hepatology, 2023 Jul; 79(1), p. 226-239.
EPub date: 2023-02-26 00:00:00.0.
PMID: 36854345
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Clinical Outcomes of Patients With Suspicious (LI-RADS 4) Liver Observations.
Authors: Onyirioha K. , Joshi S. , Burkholder D. , Yekkaluri S. , Parikh N.D. , Singal A.G. , North American Liver Cancer (NALC) Consortium .
Source: Clinical Gastroenterology And Hepatology : The Official Clinical Practice Journal Of The American Gastroenterological Association, 2023 Jun; 21(6), p. 1649-1651.e2.
EPub date: 2022-04-09 00:00:00.0.
PMID: 35413448
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Precision HCC Surveillance: It Is All in the Number (Needed).
Authors: Singal A.G. , Parikh N.D. , Hoshida Y. .
Source: Digestive Diseases And Sciences, 2023 Mar; 68(3), p. 720-722.
EPub date: 2022-10-27 00:00:00.0.
PMID: 36302995
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Recall patterns and risk of primary liver cancer for subcentimeter ultrasound liver observations: a multicenter study.
Authors: Singal A.G. , Ghaziani T.T. , Mehta N. , Zhou K. , Grinspan L.T. , Benhammou J.N. , Moon A.M. , Yang J.D. , Salgia R. , Pillai A. , et al. .
Source: Hepatology Communications, 2023-03-01 00:00:00.0; 7(3), .
EPub date: 2023-03-07 00:00:00.0.
PMID: 36881615
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Hepatocellular carcinoma surveillance in patients with non-alcoholic fatty liver disease.
Authors: Seif El Dahan K. , Daher D. , Singal A.G. .
Source: Clinical And Molecular Hepatology, 2023 Feb; 29(Suppl), p. S207-S219.
EPub date: 2022-09-14 00:00:00.0.
PMID: 36103899
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Blood-based biomarkers for hepatocellular carcinoma screening: Approaching the end of the ultrasound era?
Authors: Parikh N.D. , Tayob N. , Singal A.G. .
Source: Journal Of Hepatology, 2023 Jan; 78(1), p. 207-216.
EPub date: 2022-09-08 00:00:00.0.
PMID: 36089157
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Emerging Tools for Hepatocellular Carcinoma Surveillance.
Authors: Singal A.G. , Reig M. , Villanueva A. .
Source: The American Journal Of Gastroenterology, 2022-12-01 00:00:00.0; 117(12), p. 1948-1951.
EPub date: 2022-09-16 00:00:00.0.
PMID: 36114768
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Clinical outcomes of patients with Liver Imaging Reporting and Data System 3 or Liver Imaging Reporting and Data System 4 observations in patients with cirrhosis: A systematic review.
Authors: Kanneganti M. , Marrero J.A. , Parikh N.D. , Kanwal F. , Yokoo T. , Mendiratta-Lala M. , Rich N.E. , Gopal P. , Singal A.G. .
Source: Liver Transplantation : Official Publication Of The American Association For The Study Of Liver Diseases And The International Liver Transplantation Society, 2022-08-18 00:00:00.0; , .
EPub date: 2022-08-18 00:00:00.0.
PMID: 35980600
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Reply.
Authors: Singal A.G. , Schoenberger H. , Fetzer D. .
Source: Clinical Gastroenterology And Hepatology : The Official Clinical Practice Journal Of The American Gastroenterological Association, 2022 Jul; 20(7), p. 1618-1619.
EPub date: 2021-08-16 00:00:00.0.
PMID: 34411711
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HCC surveillance improves early detection, curative treatment receipt, and survival in patients with cirrhosis: A meta-analysis.
Authors: Singal A.G. , Zhang E. , Narasimman M. , Rich N.E. , Waljee A.K. , Hoshida Y. , Yang J.D. , Reig M. , Cabibbo G. , Nahon P. , et al. .
Source: Journal Of Hepatology, 2022 Jul; 77(1), p. 128-139.
EPub date: 2022-02-06 00:00:00.0.
PMID: 35139400
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Associations of Ultrasound LI-RADS Visualization Score With Examination, Sonographer, and Radiologist Factors: Retrospective Assessment in Over 10,000 Examinations.
Authors: Fetzer D.T. , Browning T. , Xi Y. , Yokoo T. , Singal A.G. .
Source: Ajr. American Journal Of Roentgenology, 2022 06; 218(6), p. 1010-1020.
EPub date: 2021-12-15 00:00:00.0.
PMID: 34910539
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Early detection of hepatocellular carcinoma: roadmap for improvement.
Authors: Melendez-Torres J. , Singal A.G. .
Source: Expert Review Of Anticancer Therapy, 2022 06; 22(6), p. 621-632.
EPub date: 2022-05-10 00:00:00.0.
PMID: 35514249
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Association between ultrasound quality and test performance for HCC surveillance in patients with cirrhosis: a retrospective cohort study.
Authors: Chong N. , Schoenberger H. , Yekkaluri S. , Fetzer D.T. , Rich N.E. , Yokoo T. , Gopal P. , Manwaring C. , Quirk L. , Singal A.G. .
Source: Alimentary Pharmacology & Therapeutics, 2022-02-15 00:00:00.0; , .
EPub date: 2022-02-15 00:00:00.0.
PMID: 35170052
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Patient Preferences for Hepatocellular Carcinoma Surveillance Parameters.
Authors: Woolen S.A. , Singal A.G. , Davenport M.S. , Troost J.P. , Khalatbari S. , Mittal S. , Siddiqui S. , Fobar A. , Morris J. , Odewole M. , et al. .
Source: Clinical Gastroenterology And Hepatology : The Official Clinical Practice Journal Of The American Gastroenterological Association, 2022 01; 20(1), p. 204-215.e6.
EPub date: 2021-02-19 00:00:00.0.
PMID: 33618022
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Overdiagnosis of hepatocellular carcinoma: Prevented by guidelines?
Authors: Rich N.E. , Singal A.G. .
Source: Hepatology (baltimore, Md.), 2021-12-19 00:00:00.0; , .
EPub date: 2021-12-19 00:00:00.0.
PMID: 34923659
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Multicenter Randomized Clinical Trial of a Mailed Outreach Strategy for Hepatocellular Carcinoma Surveillance.
Authors: Singal A.G. , Reddy S. , Radadiya Aka Patel H. , Villarreal D. , Khan A. , Liu Y. , Cerda V. , Rich N.E. , Murphy C.C. , Tiro J.A. , et al. .
Source: Clinical Gastroenterology And Hepatology : The Official Clinical Practice Journal Of The American Gastroenterological Association, 2021-12-10 00:00:00.0; , .
EPub date: 2021-12-10 00:00:00.0.
PMID: 34902568
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Risk of Hepatocellular Carcinoma in Patients With Indeterminate (LI-RADS 3) Liver Observations.
Authors: Arvind A. , Joshi S. , Zaki T. , Burkholder D. , Parikh N.D. , Singal A.G. , North American Liver Cancer (NALC) Consortium .
Source: Clinical Gastroenterology And Hepatology : The Official Clinical Practice Journal Of The American Gastroenterological Association, 2021-12-10 00:00:00.0; , .
EPub date: 2021-12-10 00:00:00.0.
PMID: 34902571
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Dynamic Changes in Ultrasound Quality for Hepatocellular Carcinoma Screening in Patients With Cirrhosis.
Authors: Schoenberger H. , Chong N. , Fetzer D.T. , Rich N.E. , Yokoo T. , Khatri G. , Olivares J. , Parikh N.D. , Yopp A.C. , Marrero J.A. , et al. .
Source: Clinical Gastroenterology And Hepatology : The Official Clinical Practice Journal Of The American Gastroenterological Association, 2021-06-10 00:00:00.0; , .
EPub date: 2021-06-10 00:00:00.0.
PMID: 34119640
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International Liver Cancer Association (ILCA) White Paper on Biomarker Development for Hepatocellular Carcinoma.
Authors: Singal A.G. , Hoshida Y. , Pinato D.J. , Marrero J. , Nault J.C. , Paradis V. , Tayob N. , Sherman M. , Lim Y.S. , Feng Z. , et al. .
Source: Gastroenterology, 2021 Jun; 160(7), p. 2572-2584.
EPub date: 2021-03-09 00:00:00.0.
PMID: 33705745
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Novel Application of Predictive Modeling: A Tailored Approach to Promoting HCC Surveillance in Patients With Cirrhosis.
Authors: Singal A.G. , Chen Y. , Sridhar S. , Mittal V. , Fullington H. , Shaik M. , Waljee A.K. , Tiro J. .
Source: Clinical Gastroenterology And Hepatology : The Official Clinical Practice Journal Of The American Gastroenterological Association, 2021-03-02 00:00:00.0; , .
EPub date: 2021-03-02 00:00:00.0.
PMID: 33662594
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Reply to: "Challenges associated with the roll-out of HCC surveillance in sub-Saharan Africa - the case of Uganda".
Authors: Singal A.G. , Lampertico P. , Nahon P. .
Source: Journal Of Hepatology, 2020 11; 73(5), p. 1273-1274.
EPub date: 2020-08-13 00:00:00.0.
PMID: 32800586
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Cost-Effectiveness of Hepatocellular Carcinoma Surveillance: An Assessment of Benefits and Harms.
Authors: Parikh N.D. , Singal A.G. , Hutton D.W. , Tapper E.B. .
Source: The American Journal Of Gastroenterology, 2020 Oct; 115(10), p. 1642-1649.
PMID: 32530829
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Conceptual Model for the Hepatocellular Carcinoma Screening Continuum: Current Status and Research Agenda.
Authors: Singal A.G. , Lok A.S. , Feng Z. , Kanwal F. , Parikh N.D. .
Source: Clinical Gastroenterology And Hepatology : The Official Clinical Practice Journal Of The American Gastroenterological Association, 2020-09-19 00:00:00.0; , .
EPub date: 2020-09-19 00:00:00.0.
PMID: 32961340
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Benefits and Harms of Hepatocellular Carcinoma Surveillance in a Prospective Cohort of Patients with Cirrhosis.
Authors: Singal A.G. , Patibandla S. , Obi J. , Fullington H. , Parikh N.D. , Yopp A.C. , Marrero J.A. .
Source: Clinical Gastroenterology And Hepatology : The Official Clinical Practice Journal Of The American Gastroenterological Association, 2020-09-10 00:00:00.0; , .
EPub date: 2020-09-10 00:00:00.0.
PMID: 32920214
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Depression and Anxiety Are Common Among Patients With Cirrhosis.
Authors: Hernaez R. , Kramer J.R. , Khan A. , Phillips J. , McCallister K. , Chaffin K. , Hernandez A.P. , Fullington H. , Ortiz C. , Blackwell J.M. , et al. .
Source: Clinical Gastroenterology And Hepatology : The Official Clinical Practice Journal Of The American Gastroenterological Association, 2020-08-21 00:00:00.0; , .
EPub date: 2020-08-21 00:00:00.0.
PMID: 32835845
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Is hepatocellular carcinoma surveillance in high-risk populations effective?
Authors: Onyirioha K. , Mittal S. , G Singal A. .
Source: Hepatic Oncology, 2020-07-24 00:00:00.0; 7(3), p. HEP25.
EPub date: 2020-07-24 00:00:00.0.
PMID: 32774835
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Patient-Reported Barriers are Associated With Receipt of Hepatocellular Carcinoma Surveillance in a Multicenter Cohort of Patients With Cirrhosis.
Authors: Singal A.G. , Tiro J.A. , Murphy C.C. , Blackwell J.M. , Kramer J.R. , Khan A. , Liu Y. , Zhang S. , Phillips J.L. , Hernaez R. .
Source: Clinical Gastroenterology And Hepatology : The Official Clinical Practice Journal Of The American Gastroenterological Association, 2020-07-03 00:00:00.0; , .
EPub date: 2020-07-03 00:00:00.0.
PMID: 32629122
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Thrombocytosis is associated with worse survival in patients with hepatocellular carcinoma.
Authors: Liu P.H. , Hsu C.Y. , Su C.W. , Huang Y.H. , Hou M.C. , Rich N.E. , Fujiwara N. , Hoshida Y. , Singal A.G. , Huo T.I. .
Source: Liver International : Official Journal Of The International Association For The Study Of The Liver, 2020-06-08 00:00:00.0; , .
EPub date: 2020-06-08 00:00:00.0.
PMID: 32511831
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Hepatocellular carcinoma tumour volume doubling time: a systemic review and meta-analysis.
Authors: Nathani P. , Gopal P. , Rich N. , Yopp A. , Yokoo T. , John B. , Marrero J. , Parikh N. , Singal A.G. .
Source: Gut, 2020-05-12 00:00:00.0; , .
EPub date: 2020-05-12 00:00:00.0.
PMID: 32398224
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Epidemiology and surveillance for hepatocellular carcinoma: New trends.
Authors: Singal A.G. , Lampertico P. , Nahon P. .
Source: Journal Of Hepatology, 2020 Feb; 72(2), p. 250-261.
PMID: 31954490
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Role of imaging in management of hepatocellular carcinoma: surveillance, diagnosis, and treatment response.
Authors: Osho A. , Rich N.E. , Singal A.G. .
Source: Hepatoma Research, 2020; 6, .
EPub date: 2020-08-27 00:00:00.0.
PMID: 32944652
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Harms of hepatocellular carcinoma surveillance.
Authors: Petrasek J. , Singal A.G. , Rich N.E. .
Source: Current Hepatology Reports, 2019 Dec; 18(4), p. 383-389.
EPub date: 2019-10-15 00:00:00.0.
PMID: 33214987
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Hepatocellular carcinoma surveillance in the 21st century: Saving lives or causing harm?
Authors: Hanouneh I.A. , Alkhouri N. , Singal A.G. .
Source: Clinical And Molecular Hepatology, 2019 Sep; 25(3), p. 264-269.
EPub date: 2019-03-04 00:00:00.0.
PMID: 30827081
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Surveillance for Hepatocellular Carcinoma: Current Best Practice and Future Direction.
Authors: Kanwal F. , Singal A.G. .
Source: Gastroenterology, 2019 07; 157(1), p. 54-64.
EPub date: 2019-04-12 00:00:00.0.
PMID: 30986389
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AGA Clinical Practice Update on Interaction Between Oral Direct-Acting Antivirals for Chronic Hepatitis C Infection and Hepatocellular Carcinoma: Expert Review.
Authors: Singal A.G. , Lim J.K. , Kanwal F. .
Source: Gastroenterology, 2019 Jun; 156(8), p. 2149-2157.
EPub date: 2019-03-13 00:00:00.0.
PMID: 30878469
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Hepatocellular Carcinoma Screening Is Associated With Increased Survival of Patients With Cirrhosis.
Authors: Choi D.T. , Kum H.C. , Park S. , Ohsfeldt R.L. , Shen Y. , Parikh N.D. , Singal A.G. .
Source: Clinical Gastroenterology And Hepatology : The Official Clinical Practice Journal Of The American Gastroenterological Association, 2019 Apr; 17(5), p. 976-987.e4.
EPub date: 2018-10-26 00:00:00.0.
PMID: 30616961
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