Gastroenterology & Hepatology

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1 Gastroenterology & Hepatology 2017 DIGESTIVE DISEASE WEEK ACCEPTED ABSTRACTS FACULTY POSTERS AND PRESENTATIONS CHICAGO, IL MAY 5-9, 2017

2 ORAL PRESENTATIONS SATURDAY, MAY 6 8:15 AM S101a 2:30 PM S406a Research Forum- Epigenetic Alterations in Mucosal Stem Cells in Pediatric Crohn s Disease Wa Xian, Jeffrey S. Hyams, Frank D. McKeon, Francisco Sylvester, Khek-Yu- Ho. Jason K. Hou Food Intolerance- A Biphasic 13 C-α-Limit Dextrin/ 13 C-Glucose Breath Test Identifies Mucosal Disaccharidase Insufficiency as a Cause for Starchmaldigestion Antone R. Opekun, Aileen M. DeJonge, Jill L. Martin, Bruno P. Chumpitazi [Abstract on pages 8 & 9] SUNDAY, MAY 7 8:30 AM S501 9:00 AM S304b 9:00 AM S403a 4:15 PM S403a GERD and Barrett s Esophagus: Medical Surgical and Endoscopic- Rates, Risk and Predictors of Barrett s Esophagus Recurrence After Radiofrequency Ablation in a Community Practice Setting: a National Veterans Cohort Study Mimi Tan, Kavin Kanthasamy, Allison G. Yeh, Daniel Kil, Lisa Pompeii, Xiaoying Yu, Hashem B. El-Serag, Aaron Thrift. Hepatobiliary Neoplasia- Evaluation of screening approaches for hepatocellular carcinoma in cirrhosis patients from the Veteran s Affairs Health Care System Nabihah Tayob, Peter Richardson, Fasiha Kanwal, Donna White, Xiaoying Yu, Jessica Davila, Hashem B. El-Serag Portal Hypertension and Complications of Cirrhosis: Clinical and Experimental- Robust Metabolomic Signature is Associated with Altered Renal Hemodynamics in Patients with Cirrhosis Ayse L. Mindikoglu, Antone R. Opekun, Cristian Coarfa, Nagireddy Putluri, Sridevi Devaraj, David Sheikh-Hamad, John M. Vierling, John A. Goss, Abbas Rana, Gagan K. Sood, Prasun K. Jalal, Lesley A. Inker, Robert P. Mohney, Hocine Tighiouart, Robert H. Christenson, Thomas C. Dowling, Matthew R. Weir, Stephen L. Seliger, Wiliam R. Hutson, Charles Howell, Jean-Pierre Raufman, Laurence S. Magder. [Abstract on pages 10-13] Clinical Plenary- Risk of Hepatocellular Cancer in U.S. Patients Treated with Direct Acting Antiviral Agents Fasiha Kanwal, Jennifer Kramer, Yumei Cao, Hashem El-Serag [Abstract on page 14] Page 2

3 4:30 PM S406a HCV Therapeutics I- Real world experience with elbasvir/grazoprevir in the Veterans Affairs Healthcare System Jennifer Kramer, Amy Puenpatom, Kevin Erickson, Yumei Cao, Hashem El- Serag, Fasiha Kanwal [Abstract on page 15] MONDAY, MAY 8 8:15 S105bcd Research Forum- One-day Behavioral Intervention for Patients with Inflammatory Bowel Disease and Co-morbid Psychological Distress A Pilot Study Rohini R. Vanga, Elyse Thakur, Iliana Gonzalez, Lilian Dindo, Jason K. Hou [Abstract on page 16] TUESDAY, MAY 9 2:00 PM S403a 3:15 PM S405 Health-Care in the Hospital and Clinic for Chronic Liver Disease- One Year Risk Trajectories of Mortality and Readmission in Patients with Cirrhosis-Related Hospitalizations Aylin Tansel, Jennifer R. Kramer, Hua Feng, Hashem B. El-Serag, Fasiha Kanwal Hepatitis C: Diagnostics and Natural History- Performance of AFP-based hepatocellular carcinoma surveillance in cirrhosis patients with cured HCV Nabihah Tayob, Peter Richardson, Fasiha Kanwal, Donna White, Xiaoying Yu, Winnie Y. Zou, Diana Castillo, Jessica Davila, Hashem B. El-Serag Page 3

4 POSTER PRESENTATIONS SATURDAY, MAY 6 Title Session Authors *Poster of Destination: Utilizing Natural Language Processing (NLP) to Accurately Identify Fatty Liver Disease [Abstract on page 17] Experimental Steatohepatitis Joseph Redman, Yamini Natarajan, Jingqi Wang, Muzammil Hanif, Hua Feng, Jennifer Kramer, Roxanne Desiderio, Hua Xu, Hashem El- Serag, Jason Hou, Fasiha Kanwal Cloning Colonic Stem Cells of Ulcerative Colitis Patients from Endoscopic Biopsies Statins Use and Overall Survival in Pancreatic Cancer Patients: A Systematic Review and Meta-analysis [Abstract on page 18] Duodenal eosinophilia is associated with early satiety among US adult patients with functional dyspepsia Quality of Care Provided to Patients with Chronic Hepatitis B Virus Infection [Abstract on pages 19-21] Obesity may place young minorities at higher risk for presentation with late stage colorectal cancer [Abstract on pages 22-24] Stem Cells and Organoids Pancreatic Neoplasms: Precursors, Biology, Diagnosis and Therapy Functional Dyspepsia: Nausea and Vomiting EGD Hepatitis B: Epidemiology, Natural History and Treatment Metabolism, Obesity, Microbiome and Nutrition in GI Cancer Pathogenesis Wa Xian, Francisco Sylvester, Jason K. Hou, Jeffrey S. Hyams, Khek-Yu Ho, Frank D. McKeon Srikar R. Mapakshi, Jennifer R. Kramer, Kathryn E. Royse, Elizabeth Chiao, Jose M. Garcia, Fasiha Kanwal, Hashem B. El-Serag, Li Jiao, Donna White M. Ellionore Jarbrink-Sehgal, Jordan Sparkman, Linda K. Green, David Y. Graham, Marjorie M. Walker, Nicholas J. Talley, Hashem B. El-Serag John Ha, Jennifer Kramer, Peter Richardson, Ronald Omino, Fasiha Kanwal Ashish Sharma, Jordan Sparkman, Johanna Chan, Hoda M. Malaty, Milena Gould Suarez SUNDAY, MAY 7 Title Session Authors *Poster of Distinction: Serum Creatinine in Female Patients with Cirrhosis Unfairly Bias Liver Transplant Wait List Ranking: Implications for Elimination of Gender Disparities in Access to Orthotopic Liver Transplantation [Abstract on pages 25-27] Liver Transplant Outcomes Ayse L. Mindikoglu, Antone R. Opekun, William E. Mitch, Laurence S. Magder, Robert Christenson, Thomas C. Dowling, Matthew R. Weir, Stephen L. Seliger, Charles Howell, Jean-Pierre Raufman, Abbas Rana, Norman L. Sussman, John M. Vierling Page 4

5 External validation of the Michigan Barrett s Esophagus prediction Tool (M- BERET) [Abstract on page 28] Aggressive and Advanced Non-cardia Gastric Cancer in Young Hispanic Immigrants to the United States [Abstract on pages 29-31] Embolization for Closure of Spontaneous Porto-systemic Shunts in Patient with Cirrhosis and Refractory Hepatic Encephalopathy : A Systematic Review and Meta-Analysis Most Patients with Cirrhosis Come to the Hospital Malnourished and Leave Even Worse [Abstract on pages 32 & 33] Characteristics and outcomes of intensive care in patients with cirrhosis at safetynet hospital: a multicenter study Characterization of infections and their impact on patients with cirrhosis admitted to urban safety-net hospitals: a multi-center study Evaluation of a multimodal colorectal cancer screening and diagnostic intervention aimed to address health disparities in a high-volume safety-net healthcare system Barrett's Esophagus: Diagnosis, Management and Surveillance Gastric Neoplasms: Precursor Lesions, Biology, Diagnosis and Clinical Therapeutics Portal Hypertension Portal Hypertension and Complications of Cirrhosis: Clinical and Experimental Portal Hypertension and Complications of Cirrhosis: Clinical and Experimental Portal Hypertension and Complications of Cirrhosis: Clinical and Experimental Colon Cancer Screening Aaron P. Thrift, Thomas Vaughan, Lesley A. Anderson. David Whiteman, Hashem B. El-Serag Ashish Sharma, Rollin George, David Y. Graham, Hoda M. Malaty, Maya Balakrishnan Rashmee Patil, Supannee Rassameehiran, Ruchi Patel, Maya Balakrishnan, Gagan K. Sood Matthew Glover, Emily Mao, Maya Balakrishnan VV Pavan Kedar Mukthinuthalapati, Samuel A Akinyeye, Zachary P. Fricker, Maya Balakrishnan, Michelle T. Long, Eric Orman, Naga P. Chalasani, Marwan S. Ghabril Zachary P. Fricker, Samuel A. Akinyeye, VV Pavan Kedar Mukthinuthalapati, Maya Balakrishnan, Naga P. Chalasani, Marwan S. Ghabril, Michelle T. Long P.A. Allred, Jane R. Motealegre, Milena Gould Suarez, Loretta A. Hanser, Roshanda S. Chenier, Benjamin L. Muscher, Larry Scott, Maria L. Jibaja-Wiess. MONDAY, MAY 8 Title Session Authors *Poster of Distinction: Absolute risk of hepatocellular carcinoma in a large, geographically and ethnically diverse cohort of patients with nonalcoholic fatty liver disease [Abstract on pages 34 & 35] IBD Patients With Severe Disease Are at Greater Risk of Developing Pneumonia Prior to IBD Diagnosis Non-Alcoholic Fatty Liver Diseases and NASH IBD: Disease Complications Jennifer R. Kramer, Michael Lin, Hua Feng, Maneerat Chayanupatkul, Xiaoying Yu, Srikar R. Mapakshi, Roxanne Desiderio, Liang Li, Aaron Thrift, Hashem B. El-Serag, Fasiha Kanwal Martin H. Gregory, Matthew A. Ciorba, Wyndy L. Wiitala, Ryan W. Stidham, Peter D. Higgins, Jason K. Hou, Linda A. Feagins, Sahil M. Govani, Akbar K. Waljee Page 5

6 Predictors of Positive Secretin Pancreatic Function Testing: Results of a Twenty Year Study Pancreas Cysts, IPMN and CP Darshan J. Kothari, Gyanprakash A. Ketwaroo, Steven D. Freedman, Sunil Sheth Risk of HCC in HCV Related Cirrhosis after HCV Clearance with Direct Acting Antivirals: A Systematic Review and Meta- Analysis Diagnostic Utility of Non-Invasive Markers for Staging of Liver Disease in Hepatitis C Patients with ESRD on Hemodialysis HCV: Diagnostics, Epidemiology and Natural History HCV: Diagnostics, Epidemiology and Natural History Supannee Rassameehiran, Rashmee Patil, Ruchi Patel, Gagan K. Sood Ruchi Patel, Supanee Rassameehiran, Rashmee Patil, Sadhna Dhingra, Gagan K. Sood TUESDAY, MAY 9 Title Session Authors *Poster of Distinction: Validation of International Classification of Disease, 10 th Version (ICD-10) codes for cirrhosis and its complications. [Abstract on pages 36 & 37] Health-Services Research in Liver Disease Srikar R. Mapakshi, Jennifer R. Kramer, Peter Richardson, Fasiha Kanwal Temporal Trends in Pre-diagnosis Screening and Surveillance among Patients with Newly Diagnosed CRC. A Healthcare System Quality Measure [Abstract on page 38] Prospective Implementation of Algorithmic Patient Selection For Gastrostomy Tube Placement Consultations: A Pre-, Post Analysis [Abstract on pages 39 & 40] Utilizing a multidisciplinary tumor board for the management of hepatocellular carcinoma s associated with improved outcomes Psychological Treatments for irritable bowel syndrome conducted in gastroenterology settings: A systematic review [Abstract on page 41] Health-Care Delivery and Policy (Practice Management, Reimbursement, Access to Care and Policy) Health-Care Delivery and Policy (Practice Management, Reimbursement, Access to Care and Policy) Health-Services Research in Liver Disease IBS Jianhua A. Tau, Jessica Bernica, Abdullah Shaikh, Aaron P. Thrift, Hashem B. El-Serag Joseph J Cano, Aaron P. Thrift, Maria Velez, Hashem B. El-Serag Sarah Temple, Yvonne H. Sada, Hashem El-Serag, Sahil Mittal, Fasiha Kanwal, Daniel A. Anaya, Jessica Davila Elyse Thakur, Johanna Chan, Mark Lumley, Jeffrey Cully, Hashem El- Serag Page 6

7 Altered expression of autophagy-related genes in human colon cancer [Abstract on pages 42-45] A New Paradigm in Intestinal Epithelial Self-defense: Changes in Actin Dynamics Regulated by Villin and Gelsolin are Determinants of Host Defense One Explanation for the Reported Increase in Gastric Cancer Incidence in the U.S. [Abstract on pages 46 & 47] Incidence and Predictors of Early Hospital Readmission among Patients with Cirrhosis Hospitalized in Urban Safety Net Hospitals [Abstract on pages 48 & 49] Analysis of risk factors and clinicopathological characteristics of young colorectal cancers in an underprivileged population [Abstract on pages 50 & 51] Assessment of Cardiovascular Risk and Statin Utilization for Primary Prevention in Patients with Non alcoholic fatty Liver Disease (NAFLD) Biomarkers for Detection, Treatment and Prognosis of GI Cancers Epithelial Cell Function Epidemiology and Population Health Screening: Colorectal Cancer, Esophageal Cancer, Hepatocellular Carcinoma and Other Screening Epidemiology Epidemiology Clinical Steatohepatitis Themistoklis Kourkoumpetis, Liang Chen, Michael Ittmann, David Y. Graham, Hashem B. El- Serag, Li Jiao Swati Roy, Srinivas Patnaik, Yaohong Wang, Amin Esmaeilniakooshkghazi, Sudeep P. George, Jason K. Hou, Seema Khurana Rollin George, Ashish Sharma, David Y. Graham, Hoda Malaty, Maya Balakrishnan Sam A. Akinyeye, VV Pavan Kedar Mukthinuthalapati, Zachary P. Fricker, Michelle T. Long, Naga P. Chalasani, Marwan S. Ghabril, Maya Balakrishnan Ashish Sharma, Nabeel U. Moon, Johanna Chan, Hoda M. Malaty, Milena Gould Suarez Pagnesh J. Patel, Rashmee Patil, Aylin Tansel, Sadhna Dhingra, Gagan K. Sood Page 7

8 CONTROL ID: CURRENT CATEGORY: Intestinal Disorders PRESENTATION TYPE: AGA Institute Oral or Poster PRESENTER: Antone Opekun PRESENTER ( ONLY): Abstract TITLE: A Biphasic 13 C-α-Limit Dextrin/ 13 C-Glucose Breath Test Identifies Mucosal Disaccharidase Starch Maldigestion AUTHORS (LAST NAME, FIRST NAME): Opekun, Antone R. 1, 2 ; DeJonge, Aileen M. 3 ; martin, jill L. 1 ; Chumpitazi, Bruno P. 1, 2 INSTITUTIONS (ALL): 1. Baylor College of Medicine, Pearland, TX, United States. 2. GI, Nutrtion and Hepatology, Texas Childrens Hospital, Houston, TX, United States. 3. Consultant, Independent, Hudsonville, IL, United States. ABSTRACT BODY: Abstract Body: Starch maldigestion may result from acquired disaccharidase deficiencies (infection, inflammatory bowel (IBD), chemoradiotherapy, FBS) affecting the small bowel and/or congenital disaccharidase deficiencies (e.g., congenital sucrase-isomaltase deficiency [CSID]). A biphasic 13 C-sucrose breath test to assess sucrose maldigestion was recently developed (PMID ). However, whether a biphasic breath test can be used to diagnose starch maldigestion related to disaccharidase (isomaltase, maltase and/or glucoamylase) deficiency is unknown. 13 C-α-Limit dextrin appears to be an ideal test substrate. α-limit dextrin is partially digested dietary starch, made soluble by the action of pancreatic α-amylase, to the "limit" it is capable of doing so. This makes substrate available for final brush border disaccharidase action and glucose absorption. Objective: This study sought to validate the biphasic 13 C-α-limit dextrin (LDx; the soluble starch product following α- amylase hydrolysis) breath test as a means of measuring isomaltase, maltase and glucoamylase activities in the small intestine. We hypothesized that an optimal breath test would align well according to known CSID genotypes. (E.g., lowest scores with compound heterozygous affected subjects). Methods: This study of normal adult subjects and patients diagnosed with CSID compared subject digestive oxidation rates with known SI genotypes. Thirteen subjects (Group A: four compound mutations (3p26; 2 hits), Group B: six heterozygous mutations, Group C: three WT/WT controls) ingested 13 C-α-LDx (phase 1) followed 75 minutes later by a super-dose (3x) of 13 C-glucose loads (phase two) to mask tracer carryover from phase one. A baseline and postingestion breath samples were collected at 60 and 75 minutes respectively. 13 CO 2 breath enrichments (D ) were then measured using an infrared mass dispersive spectrophotometry. Timed oxidation results were expressed as comparative ratio of 13 C-α-LDx: 13 C-glucose [coefficient of glucose oxidation (CGO) for LDx]. Results: Differences were found between compound heterozygous CSID group A and heterozygous SI group B (ANOVA: p<0.05) as well as between CSID group A and WT/WT control group C (ANOVA: p<0.01), Figure 1. The test was easily tolerated and no adverse reactions were observed. Conclusion: Starch maldigestion related to disaccharidase insufficiency may be non-invasively diagnosed using a biphasic 13 C-α-LDx/ 13 C-glucose breath test. The one-day testing appears convenient. Further development is necessary to optimize testing parameters and assess the ability of this test to assess the efficacy of therapies (e.g. enzyme replacement therapy). The test, that uses a point-of-care instrument that is already widely available, may be useful to herald the need for confirmatory endoscopic biopsy disaccharidase assay that might not be otherwise planned. (no table selected) Page 8

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10 CONTROL ID: CURRENT CATEGORY: Portal Hypertension and Other Complications of Cirrhosis CURRENT SUBCATEGORY/DESCRIPTORS: PO2 Ascites, Renal Dysfunction, and Hepatorenal Syndrome PRESENTATION TYPE: AASLD Oral or Poster PRESENTER: Ayse Mindikoglu PRESENTER ( ONLY): Abstract TITLE: Robust Metabolomic Signature is Associated with Altered Renal Hemodynamics in Patients with Cirrhosis AUTHORS (LAST NAME, FIRST NAME): Mindikoglu, Ayse L. 1, 2 ; Opekun, Antone R. 2, 16 ; Coarfa, Cristian 3 ; Putluri, Nagireddy 4 ; Devaraj, Sridevi 5 ; Sheikh-Hamad, David 6 ; Vierling, John M. 1, 2 ; Goss, John A. 1 ; Rana, Abbas 1 ; Sood, Gagan K. 1 ; Jalal, Prasun K. 1 ; Inker, Lesley A. 7 ; Mohney, Robert P. 9 ; Tighiouart, Hocine 10 ; Christenson, Robert H. 8 ; Dowling, Thomas C. 11 ; Weir, Matthew R. 12 ; Seliger, Stephen L. 12 ; Hutson, William R. 13 ; Howell, Charles 14 ; Raufman, Jean-Pierre 13 ; Magder, Laurence S. 15 INSTITUTIONS (ALL): 1. Michael E. DeBakey Department of Surgery, Division of Abdominal Transplantation, Baylor College of Medicine, Houston, TX, United States. 2. Department of Medicine, Division of Gastroenterology and Hepatology, Baylor College of Medicine, Houston, TX, United States. 3. Molecular and Cell Biology-Molecular Regulation, Baylor College of Medicine, Houston, TX, United States. 4. Molecular and Cell Biology, Baylor College of Medicine, Houston, TX, United States. 5. Clinical Chemistry and Point of Care Technology, Texas Children s Hospital and Health Centers, Department of Pathology and Immunology, Baylor College of Medicine, Houston, TX, United States. 6. Department of Medicine, Division of Nephrology, Baylor College of Medicine, Houston, TX, United States. 7. Department of Medicine, Division of Nephrology, Tufts University School of Medicine, Boston, MA, United States. 8. Department of Pathology, University of Maryland School of Medicine, Baltimore, MD, United States. 9. Metabolon, Inc, Durham, NC, United States. 10. Institute for Clinical Research and Health Policy Studies, Biostatistics, Epidemiology and Research Design (BERD) Center, Tufts University School of Medicine, Boston, MA, United States. 11. Ferris State University, College of Pharmacy, Grand Rapids, MI, United States. 12. Department of Medicine, Division of Nephrology, University of Maryland School of Medicine, Baltimore, MD, United States. 13. Department of Medicine, Division of Gastroenterology and Hepatology, University of Maryland School of Medicine, Baltimore, MD, United States. 14. Department of Medicine, Howard University College of Medicine, Washington, DC, United States. 15. Department of Epidemiology and Public Health, Division of Biostatistics and Bioinformatics, University of Maryland School of Medicine, Baltimore, MD, United States. 16. Department of Pediatrics, Division of Gastroenterology, Nutrition and Hepatology, Baylor College of Medicine, Houston, TX, United States. ABSTRACT BODY: Abstract Body: Background: Serum metabolomic profiling is a powerful non-invasive tool to discover biomarkers for potential early diagnosis and treatment of hepatorenal syndrome (HRS). Aim: To identify novel pathophysiological pathways using metabolomic that could be exploited for prognostic and therapeutic purposes in patients with cirrhosis and renal dysfunction. Methods: We enrolled 103 subjects with cirrhosis and performed non-targeted global metabolomics profiling on blood samples. We evaluated the metabolites for 9 clinical variables of interest and stratified the patients based on glomerular filtration rate as measured by iothalamate plasma clearance (mgfr; ml/min/1.73m 2 / <60 vs. 60), ascites (+/-) and the median values of the variables including serum creatinine (mg/dl), cystatin C (mg/l), symmetrical dimethylarginine (SDMA) (µmole/l), MELD-Na score and determined significant metabolites using a parametric t-test. We also stratified the patients in multiple variable groups based on the categorical variables including mgfr categorized as stage 1: mgfr 90, stage 2: mgfr 60 to <90, Stage 3: mgfr 30 to <60, Stage 4: mgfr 15 to <30, severity of ascites (none, diuretic-sensitive and -refractory ascites) and MELD-Na score (6-9, 10- Page 10

11 19, 20-40). ANOVA was used to detect statistically significant inducible metabolites. For each variable, the statistical significance of the metabolites was assessed for a false discovery rate-adjusted q-value of <0.05. Results: Among the 1028 metabolites identified in plasma, 17 metabolites were upregulated and significantly associated with all of the clinical variables indicative of disease severity (Figure 1). The highest median-fold-change occurred in the mean value of 4-acetamidobutanoate when patients with low-disease severity were compared to those with high disease severity across all 9 clinical variables. The lowest median-fold-change occurred with N1-methyladenosine. The 10 most inducible metabolites were 4-acetamidobutanoate, trans-aconitate, cytidine, myo-inositol, N4-acetylcystidine, N6- carbamoylthreonyladenosine, erythronate, N-acetylserine, pseudouridine, and N2,N2-dimethylguanosine. Using the metabolites/genes association compiled in the Human Metabolome Database, we further analyzed pathways enriched in the 17 metabolites. Figure 2 shows the pathways significantly associated with the 17 metabolites (P<0.01). Conclusions: Both hepatic and renal dysfunction in cirrhosis are associated with a robust metabolomic signature characterized by induction of 17 metabolites that play critical roles in pathways involving pyrimidine and purine metabolism, inositol phosphate metabolism, DNA repair, glycolysis, IL2/STAT5 signaling and lipid metabolism. This metabolomic signature may prove valuable in patients with cirrhosis as a predictor of the risk of renal progression or of regression after successful therapy of HRS. (no table selected) Page 11

12 Figure 1. Metabolomic signature of both hepatic and renal dysfunction in patients with cirrhosis. Data shown is log2 fold changes in the mean values of metabolites within the categories of 9 clinical variables.<br /> Page 12

13 Figure 2. Pathways significantly associated with the 17 metabolites (P<0.01). Page 13

14 Risk of Hepatocellular Cancer in U.S. Patients Treated with Direct Acting Antiviral Agents Fasiha Kanwal, Jennifer Kramer, Yumei Cao, Hashem El-Serag Background: With the advent of direct acting antivirals (DAA), most of the HCV patients seen in clinical practice may be in sustained virological response (SVR) within the next decade. While treatment to SVR represents a virological cure, indirect data suggest that subsequent risk of HCC may persist. Few recent studies suggested that DAA may even increase HCC risk. There are no studies that have examined the effect of DAA on HCC risk in U.S. patients with HCV. Methods: We conducted a large cohort study of patients who received DAAs from 1/1/2015 to 3/31/2016 in the national Veterans Affairs (VA) healthcare system. All patients had >6 months for treatment completion and SVR testing by 9/31/2016 (end of follow up). We used date of first filled DAA prescription as treatment initiation and last date covered by the final prescription as treatment end date. SVR12 was defined if all RNA tests were negative after end of treatment with one being recorded > 12 weeks after treatment completion. We ascertained HCC based on VA Cancer Registry or >2 instances of ICD-9/10 codes for HCC. We excluded patients diagnosed with HCC prior to DAA treatment. We calculated HCC incidence for DAA treated patients with vs. those without SVR. In a sensitivity analysis, we excluded patients who developed HCC during treatment. Among patients with SVR, we used Cox proportional hazard models to examine demographic, clinical, and virological factors associated with HCC risk. Results: We identified 22,579 patients treated with DAA. Mean age was 61.5 (SD 6.0) years, 49.3% were white, 36.5% Black, and 3.8% Hispanics. At baseline, 33.6% of patients had cirrhosis, 19.3% cirrhosis complications, 43.6% diabetes, and 61.4% had history of alcohol use. DAAs resulted in SVR in 19,518 (86.8%) patients. During a mean follow up of 12.3 (SD 3.6) months, 369 patients developed HCC (88 during and 281 following treatment) at the incidence rate of 1.28 per 100 patient-year (py). HCC risk was significantly lower in patients with vs. those without SVR (0.95 vs. 3.47/100 py, log-rank p<0.0001); this risk reduction persisted after we excluded patients who developed HCC during treatment (0.89 vs. 3.65/100 py in SVR vs. non-svr, respectively; p<0.0001). Among patients with SVR, HCC risk was higher in patients with cirrhosis (2.0/100 py, adj HR=4.79, 95% CI, ) and those with history of alcohol use (1.0/100 py, HR=1.42, 95% CI, ). Conclusion: DAA related SVR is associated with a significant reduction in HCC risk both during as well as after end of treatment compared to those without SVR. However, HCC remains considerably high in patients treated and cured with DAA. Presence of cirrhosis or history of alcohol use at the time of DAA treatment is associated with high enough risk to warrant ongoing HCC surveillance. Page 14

15 Title: Real world experience with elbasvir/grazoprevir in the Veterans Affairs Healthcare System Jennifer R. Kramer 1,2, Amy Puenpatom 3, Kevin Erickson 1,2, Yumei Cao 1, Hashem El-Serag 1,2, Fasiha Kanwal 1,2 Affiliations: 1 IQuESt, MEDVAMC, Houston, TX 2 Department of Medicine, Baylor College of Medicine, Houston, TX 3 Merck Sharp & Dohme Corp., NJ, USA Background and Aims: The new all-oral direct-acting antivirals (DAAs) cure HCV infection in an unprecedented >90% of patients in clinical trials with low rates of adverse events. Recently, the FDA approved elbasvir/grazoprevir (EBR/GRZ) for the treatment of chronic HCV genotypes 1 and 4 infections, which demonstrated high sustained virologic response (SVR) overall as well in patients with chronic kidney disease (CKD). We aimed to assess demographic and clinical characteristics of HCV-infected patients treated with EBR/GRZ in a real-world clinical setting. Methods: We conducted a nationwide retrospective observational cohort study of HCV patients seen at the US Department of Veterans Affairs (VA) using the VA Corporate Data Warehouse (includes laboratory, pharmacy, hospitalizations, and clinical diagnoses). The study population included patients with positive HCV RNA who received EBR/GRZ from January-July We examined demographic, virologic, and clinical characteristics, overall and by CKD stage estimated from the most recent estimated glomerular filtration rate (egfr). Chi-square test was used to examine differences by CKD stage. Results: A total of 2,108 HCV-infected patients treated with EBR/GRZ were included in the cohort. Most were male (97.2%), African American (54.3%), with mean age of 62 (SD = 5.8), and 80.5% infected with genotype (GT) 1 [GT1a (24.2%), GT 1b (45.2%), and GT1 unknown (10.8%)]. Of the 1,845 patients with an egfr in the year prior to treatment start date, 1,237 (67.0%) had baseline egfr (ml/min/1.73m 2 ) 60, 263 (14.3%) had stage 3 CKD (egfr 30-59), and 345 (18.7%) had stage 4-5 CKD (egfr <30). Other comorbidities included diabetes (52.9%), depression (58.7%), and HIV (3.9%). More than half had history of drug and alcohol abuse (53% and 56.9%, respectively). Compared to those with no or less advanced CKD, patients with advanced CKD were significantly more likely to be black (stages 4-5: 68.7% vs. stage 3: 57.4% vs. egfr 60: 51.5%), have more comorbidities (Charlson/Deyo Index >3: 78.0% vs % vs. 14.1%, p<0.0001), and have cirrhosis (39.1% vs. 27.4% vs. 28.4%, p=0.0003). SVR data will be available for the final presentation. Conclusions: EBR/GRZ was used for patients with and without CKD in the VA. Patients were older and had more medical and mental health comorbidities than those treated as part of registration trials for EBR/GRZ. About 33% of patients had moderate to advanced CKD. This cohort will provide important data regarding the community effectiveness of EBR/GRZ. Page 15

16 ABSTRACT FINAL ID: TITLE: One-day Behavioral Intervention for Patients with Inflammatory Bowel Disease and Co-morbid Psychological Distress A Pilot Study AUTHORS (FIRST NAME, LAST NAME): Rohini R. Vanga 1, Elyse Thakur 2, Iliana Gonzalez 1, Lilian Dindo 2, Jason K. Hou 1 ABSTRACT BODY: Abstract Body: Background: Depression and anxiety are common among patients with inflammatory bowel disease (IBD) and are associated with poor health related quality of life (HRQoL); however behavioral interventions targeting depression and anxiety among patients with IBD are lacking. Aims: 1) To develop a brief (1-day) behavioral treatment, incorporating Acceptance and Commitment Training (ACT) and IBD education for patients with IBD and comorbid depression and/or anxiety; 2) to assess the feasibility of implementing a 1-day workshop in IBD patients; and 3) to examine the preliminary efficacy of the workshop on health outcomes. Methods: Patients with IBD and concomitant anxiety and/or depression were recruited after screening to attend a 1- day (5 hour) workshop that included behavioral change training, acceptance and mindfulness training and IBD education. Assessments of disease activity [Harvey Bradshaw Index, partial Mayo score], health related quality of life [Short IBD questionnaire (SIBDQ)], and mental health [Patient Health Questionnaire- 8 (PHQ-8), Generalized Anxiety Disorder 7 (GAD-7), Acceptance and Action Questionnaire (AAQ), and Depression Anxiety Stress Scales (DASS)] were completed at baseline, 2-weeks and 3-months post-treatment. Patients also provided qualitative feedback about the intervention two weeks after the session. Changes in scores at 2 weeks and 3 months compared to baseline scores were assessed using paired-t test. Results: Twenty IBD patients who screened positive for anxiety and/or depression were enrolled (15 veteran and 5 non-veteran patients), including 10 patients with ulcerative colitis and 10 with Crohn s disease. The majority were men (75%) and Caucasian (65%). The mean age was 52.4 ± 14.9 years. At 2-weeks follow-up, 75% had an improvement in SIBDQ, with an increase from baseline from 3.42 ± 1.08 to 3.94 ± 1.23 (p = 0.006). At 2 weeks follow up, 65% patients had improvement in disease activity as well as psychological flexibility (AAQ). Anxiety and depressive symptoms were improved in approximately half of the patients, although none reached statistical significance. Majority of patients provided positive feedback regarding the intervention; they felt it was a safe space to share openly, did not find any difficulty participating in the workshop, time was adequate to spend during workshop, and having both ACT and IBD education sessions were helpful. Discussion: This pilot study provides preliminary evidence that a 1-day workshop for patients with distress and IBD is feasible and potentially efficacious for the enhancement of quality of life and improvement in distress symptoms. A larger randomized controlled trial will provide the power needed to better assess the effects of the workshop. (no table selected) (No Image Selected) Disclosure Status Page 16

17 Utilizing Natural Language Processing (NLP) to Accurately Identify Fatty Liver Disease AUTHORS: Joseph Redman, Yamini Natarajan, Jingqi Wang, Muzammil Hanif, Hua Feng, Jennifer Kramer, Roxanne Desiderio, Hua Xu, Hashem El-Serag, Jason Hou, Fasiha Kanwal Background: NLP is a branch of computer linguistics that enables identification of key clinical information from electronic medical records (EMR). This automated method can reliably analyze large amounts of data, particularly when the desired information is buried in clinical records or where ICD codes or text words are nonspecific. To date, NLP has been successfully employed in adenoma detection and determining surveillance colonoscopy intervals. Fatty liver disease (FLD) is rapidly increasing and a generally under-recognized condition. Our aim was to develop a NLP algorithm to identify patients with steatosis from radiology reports. This cohort could answer questions about the overall prevalence of disease, how often it is clinically evident and addressed, as well as the clinical course of FLD. Methods: EMR-based liver radiology reports in the VA Corporate Data Warehouse were collected from a random national sample of 1000 unique VA patients and include ultrasounds (US) (n=407), Computerized tomography (CT) scans (n=741), and magnetic resonance imaging (MRI) (n=51) performed for any indication. The presence of FLD was first determined by manual evaluation of all reports by two physicians and verified with an expert radiologist in cases of ambiguity. We performed a split validation study utilizing 70% of the reports for algorithm development, and 30% to validate the algorithm. An NLP software, Clinical Language Annotation, Modeling, and Processing Toolkit (CLAMP), was used to develop an algorithm that could identify FLD based on the overall radiology report. Performance characteristics were calculated as precision (estimate of positive predictive value), recall (estimate of sensitivity), and F- measure (harmonic mean of precision and recall). Results: In the training phase, the NLP algorithm had 95.1% recall (97/102) and 100% precision (94/94) for identifying FLD on US reports compared to manual verification. In the validation cohort, the algorithm retained a 90.0% recall (45/50) and 91.8% precision (45/49). For CT scans, the algorithm performed with 97.9% recall (46/47) and 95.8% precision (445/448) in development phase with 93.5% recall (29/31) and 96.7% precision (29/30) in validation. For MRI scans, the algorithm performed with 100% recall (6/6) and 100% precision (6/6) in development phase, and with 100% recall (5/5) and 100% precision (5/5) in validation phase. The F measure was greater than 90% for all groups. Conclusions: NLP can accurately identify patients with radiographic evidence of FLD in EMRbased radiology reports.. Using our validated NLP algorithm, we intend to develop a large cohort of veterans with FLD. Future studies will examine the clinical course (with and without elevated transaminases), health services utilization and outcomes of this cohort. Page 17

18 CONTROL ID: CURRENT CATEGORY: Gastrointestinal Oncology PRESENTATION TYPE: AGA Institute Poster PRESENTER: Srikar Mapakshi PRESENTER ( ONLY): Abstract TITLE: Statins Use and Overall Survival in Pancreatic Cancer Patients: A Systematic Review and Meta-analysis AUTHORS (LAST NAME, FIRST NAME): Mapakshi, Srikar R. 2, 1 ; Kramer, Jennifer R. 1, 2 ; Royse, Kathryn E. 1, 2 ; Chiao, Elizabeth 1, 2 ; Garcia, Jose M. 3 ; Kanwal, Fasiha 1, 2 ; El-Serag, Hashem B. 1, 2 ; Jiao, Li 1, 2 ; White, Donna 1, 2 INSTITUTIONS (ALL): 1. Baylor College of Medicine, Houston, TX, United States. 2. Michael E. DeBakey VA Medical Center, Houston, TX, United States. 3. Seattle VA Puget Sound Health Care System, Seattle, WA, United States. ABSTRACT BODY: Abstract Body: Background: Pancreatic cancer (PanC) is fatal cancer with poor five-year survival. It is projected to be the second leading cause of cancer-related deaths in the U.S. by Some experimental and clinical studies suggest antitumor properties of statins. The potential role of statins as a treatment to help improve overall survival (OS) of PanC patients is not established. Aim: To perform a systematic review and meta-analysis to examine the association between statin use and OS in PanC patients. Methods: We searched PubMed and Embase databases to identify original clinical trials and epidemiological studies evaluating the association of statin use and OS within PanC patient cohorts published from 9/1987 (FDA approval date) to 6/2016. Two investigators performed searches and abstractions from full papers published in English. We pooled results when there were 2 studies with comparable relative risk measures. We also estimated pooled risk estimates stratified by timing of statin use (prior to vs. after diagnosis only) and cancer stage (early vs. advanced). Results: We identified 8 eligible studies; 7 retrospective cohort studies and 1 randomized clinical trial (RCT), 4 were performed in the U.S with total PanC cohort sample sizes from (prevalence of statin use: 7-51%), with 100% of study participants with pancreatic ductal adenocarcinoma. Two studies did not report relevant relative risk estimates including the single RCT performed in Korea (n=114 total PanC cases, 51% randomized to statins post-diagnosis) which reported no OS benefit in unadjusted analysis (median OS=6.6 vs. 8.9 months in statin vs. placebo, p=0.74). Pooled analysis of the 6 cohort studies reporting hazards ratios (HRs) that adjusted for variables like age, sex, treatment and cancer characteristics demonstrated modest significant prolonged OS in PanC patients ever using statins vs. PanC patients never using statins (HR adj =0.77, 95% CI ). (Figure 1) Subgroup analysis based on statin timing suggested similar OS benefit if statins use started before vs. started only after diagnosis in PanC patients (HR adj =0.71, 95% CI , p=0.06 from n= 4 studies statins started pre-diagnosis vs. HR adj =0.79, 95% CI , p<0.05 from n=2 studies for statins started after, respectively). Analysis by stage demonstrated potentially stronger OS benefit from statins in PanC patients with early stage disease (HR adj =0.51, 95% CI , p<0.05 from n=2 studies for early stage vs. HR adj =0.79, 95% CI , p<0.05 from n=4 studies for advanced stage, respectively). Conclusion: Our novel pooled analysis of cohort studies suggests statin use may improve OS in PanC patients especially in those with early disease. However, additional large prospective studies that examine type, dose, duration and timing of statin use are needed to determine their potential OS benefit. (no table selected) Page 18

19 Quality of Care Provided to Patients with Chronic Hepatitis B Virus Infection John Ha 1, Jennifer Kramer 2, Peter Richardson 2, Ronald Omino 3, and Fasiha Kanwal 2,3,4 1 Department of Medicine, The University of Texas McGovern Medical School, Houston, TX 2 Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX 3 Department of Medicine, Baylor College of Medicine, Houston, TX 4 Gastroenterology, Department of Medicine, Baylor College of Medicine, Houston, TX Background: Chronic hepatitis B virus (HBV) infection is a common cause of hepatic dysfunction, cirrhosis, and hepatocellular carcinoma. Evidence-based guidelines define criteria for screening, surveillance, and treatment of HBV. However, little is known about the extent to which patients meet these standards in clinical practice. Methods: We performed a retrospective cohort study to evaluate the quality of HBV care in patients with 1 positive hepatitis B surface antigen (HBSAg) test in the national Veterans Health Administration between We used a comprehensive database (including ICD9 codes, CPT codes, laboratory, and pharmacy data) to derive the adherence rates to specified process of care measures: repeat HBsAg within 1 year of first positive test, and among patients with > 2 positive HBsAg tests, receipt of HBV envelope antigen (HBeAg) test, HBV DNA test, and antiviral treatment within 2 year of confirmed chronic HBV. We used generalized estimating equation model to identify demographic (age, gender, and race/ethnicity) and clinical (baseline ALT, presence of cirrhosis, and HIV status) predictors of meeting the indicated processes, while adjusting for clustering of care processes within patients. Last, we conducted a structured implicit review of medical records to explore the role of patient refusal, outside care, or other justifiable exclusions as explanations for non-adherence to the indicated care. Results: We identified 20,833 patients with 1 positive HBsAg test. A total of 34.6% of patients (with 1 positive HBsAg) received repeat HBsAg testing within 1 year. Of those with confirmed chronic HBV ( 2 positive HBsAg tests, n=10,336), 52.5% were tested for HBeAg and 62.3% for HBV DNA. Only 34.8% of patients received any HBV treatment (including interferon, tenofovir, entecavir, adefovir, telebivudine, and lamivudine) within 2 years of 2nd positive test. Patients with cirrhosis (adj odds ratio, OR 1.33, 95% CI ), with HIV (adj OR % CI ), or higher ALT levels at baseline (adj OR 1.71, 95% CI ) received higher quality HBV care. Compared with whites, the odds of receiving indicated care were higher in Asian (adj OR 1.48, 95% CI ) but lower in African American patients (adj OR 0.92, 95% CI ). Excluding treatment measure did not change the results. Justifiable exceptions to indicated care documented in charts included polysubstance abuse, serious medical co-morbidities, and poor compliance to routine follow-up. However, most patients did not have clear documentation for nonadherence to recommended care. Page 19

20 Conclusion: Care of patients with HBV fell short of recommended standards. Although some of the variation in the care processes was driven by clinically important factors (cirrhosis, HIV, and ALT level), most gaps in HBV care remained unexplained. Page 20

21 Forest plot showing adjusted hazard ratios for the association between statin use and overall survival in PanC patients Page 21

22 CONTROL ID: CURRENT CATEGORY: Gastrointestinal Oncology PRESENTATION TYPE: AGA Institute Poster PRESENTER: Ashish Sharma PRESENTER ( ONLY): Abstract TITLE: Obesity may place young minorities at higher risk for presentation with late stage colorectal cancer AUTHORS (LAST NAME, FIRST NAME): Sharma, Ashish 1 ; sparkman, jordan 1 ; Chan, Johanna 1 ; Malaty, Hoda M. 1 ; Gould Suarez, Milena 1 INSTITUTIONS (ALL): 1. Dept of Gastroenterology and Hepatology, Baylor College of Medicine, Houston, TX, United States. ABSTRACT BODY: Abstract Body: Background: Previous studies have shown that obesity is a possible risk factor for colorectal cancer (CRC) in young patients. Additionally, young patients with CRC present with advanced stage cancers. However, there is scarcity of data on racial and ethnic differences among young CRC patients with respect to stage of disease and obesity. Aim: To compare the prevalence of advanced stage of CRC and obesity (BMI > 30) among young and older patients by race/ethnicity. Methods: We conducted a retrospective cohort study on patients diagnosed with CRC between Patients were identified from the internal cancer registry of Harris Health System, the public medical care system serving residents in Houston, Texas. Demographic and clinical characteristics including age, race, CRC stage and BMI were obtained by chart review. Patients were classified in 2 groups: young CRC (< 50 y) and older CRC (>50 y). We applied Chi-Square test of association between the 2 groups and calculated the Odds Ratios (OR) and 95% confidence intervals. Results: 664 patients included in the current study. Demographic and clinical characteristics are presented in Table 1. Hispanics were more often diagnosed with CRC at younger age (52% vs 35%; OR=2.1, 95% CI , p=0.001), while African Americans (AA) tend to be diagnosed at an older age (33% vs 29%; OR=1.4, 95% CI , p=0.6). There was no difference in the prevalence of stage 4 CRC between the two groups (41% vs 33%, p= 0.06). Among young CRC, AA and Hispanics were 2 times more likely to be diagnosed at stage 4 than Whites respectively [40% vs 26%; OR=1.8, 95% CI 0.6-6, p=0.2, and 45% vs 26%; OR 2.2, 95% CI , p=0.1. This trend did not reach significance due to small sample size of young Whites with CRC (Table-2)]. Among older CRC, AA and Hispanics were also more likely to be diagnosed at stage 4 compared to Whites respectively (44% vs 10%; OR=4.3, 95% CI , p=0.001, and 36% vs 10%; OR=3.2, 95% CI , p=0.001). Young CRC had higher prevalence of obesity (37% vs 28%; OR=1.5, 95% CI ; p=0.01). Moreover, young AA patients with CRC tended to be more obese compared to Hispanics (46.5% vs 38.5%; OR=1.6, 95% CI , p=0.3) or Whites (46.5% vs 10.5%; OR=7.3, 95% CI , p=0.01). Conclusions: Hispanics are more likely to be diagnosed with CRC at a younger age than other races in our safety net population. Both, AA and Hispanics are more often diagnosed with advanced stage CRC compared to Whites irrespective of age. The prevalence of obesity is higher among young CRC, especially among AA and Hispanics patients. Preventive strategies of CRC in young patients should put emphasis on obesity as a risk factor. Earlier screening for CRC should be considered for Hispanic populations in addition to adhering to the recommendations to screen AA at age 45. TABLE: Table 1. Demographics and clinical characteristics. Young CC (< 50 y) n (%) Older CC ( 50 y) n (%) Page 22

23 Total cancers 150 (23) 514 (77) Age.. Range Mean Age Gender.. Male 85 (57) 277 (54) Race.. Hispanic 78 (52) 182 (35) AA 43 (29) 172 (33) White 19 (13) 99 (19) Others 10 (7) 61 (12) BMI.. Range (Kg/m2) Mean (Kg/m2) Obesity( BMI> 30) 60 (40) 150 (29) Tumor Stage (1) 8 (2) I 9 (6) 54 (11) II 30 (20) 98 (19) III 46 (31) 131 (25) IV 59 (39) 190 (37) Unknown stage 4 (3) 35 (7) Table 2. Distribution of obesity and stage of CRC by race. Young CC (< 50 y) Older CC ( 50 y) Page 23

24 Total 140 (excludes other races) Total 453 (excludes other races) Race/ethni Blacks Hispanics Whites Blacks Hispanics Whites city n=43 n=78 n=19 n=172 n=182 n=99 Stage 4 n (%) 17 (40) 35 (35) 5 (26) 75 (44) 66 (36) 10 (10) Obesity (BMI > 30) n (%) 20 (46.5) 30 (38.5) 2 (10.5) 55 (32) 50 (27) 22 (22) (No Image Selected) Page 24

25 CONTROL ID: CURRENT CATEGORY: Liver Transplantation and Liver Surgery CURRENT SUBCATEGORY/DESCRIPTORS: LO2 Donor and Allocation Issues, Living Donor and Split Liver Transplantation, and Hepatobiliary Surgery PRESENTATION TYPE: AASLD Oral or Poster PRESENTER: Ayse Mindikoglu PRESENTER ( ONLY): Abstract TITLE: Serum Creatinine in Female Patients with Cirrhosis Unfairly Bias Liver Transplant Wait List Ranking: Implications for Elimination of Gender Disparities in Access to Orthotopic Liver Transplantation AUTHORS (LAST NAME, FIRST NAME): Mindikoglu, Ayse L. 1, 2 ; Opekun, Antone R. 2, 3 ; Mitch, William E. 4 ; Magder, Laurence S. 5 ; Christenson, Robert 6 ; Dowling, Thomas C. 7 ; Weir, Matthew R. 8 ; Seliger, Stephen L. 8 ; Howell, Charles 9 ; Raufman, Jean-Pierre 10 ; Rana, Abbas 1 ; Goss, John A. 1 ; Sussman, Norman L. 1 ; Vierling, John M. 1, 2 INSTITUTIONS (ALL): 1. Michael E. DeBakey Department of Surgery, Division of Abdominal Transplantation, Baylor College of Medicine, Houston, TX, United States. 2. Department of Medicine, Division of Gastroenterology and Hepatology, Baylor College of Medicine, Houston, TX, United States. 3. Department of Pediatrics, Baylor College of Medicine, Houston, TX, United States. 4. Department of Medicine, Division of Nephrology, Baylor College of Medicine, Houston, TX, United States. 5. Department of Epidemiology and Public Health, Division of Biostatistics and Bioinformatics, University of Maryland School of Medicine, Baltimore, MD, United States. 6. Department of Pathology, University of Maryland School of Medicine, Baltimore, MD, United States. 7. Ferris State University, College of Pharmacy, Grand Rapids, MI, United States. 8. Department of Medicine, Division of Nephrology, University of Maryland School of Medicine, Baltimore, MD, United States. 9. Department of Medicine, Howard University College of Medicine, Washington, DC, United States. 10. Department of Medicine, Division of Gastroenterology and Hepatology, University of Maryland School of Medicine, Baltimore, MD, United States. ABSTRACT BODY: Abstract Body: Background: Lower serum creatinine (Cr) levels in women with cirrhosis contribute to reduced Model for End-Stage Liver Disease (MELD) scores resulting in reduced access to orthotopic liver transplantation (OLT) and significantly higher wait list mortality compared to men with comparable hepatic dysfunction (Mindikoglu et al. Liver Transpl 2010;16:1147). To further explore factors involved in this discriminatory disadvantage of women, we assessed gender differences in serum Cr levels, compared estimated Cr production in women and men with cirrhosis, accurately measured GFR (mgfr) and determined relationships between serum Cr levels and selected biomarkers of renal function. Methods: Iothalamate plasma clearance was used to determine mgfr in 103 consecutive cirrhotic subjects (women n=45; 44%) along with concurrent testing for serum Cr and selected blood biomarkers: cystatin C, beta-trace protein, beta-2 microglobulin, symmetric dimethylarginine (SDMA), asymmetric dimethylarginine (ADMA), the combination of SDMA+ADMA, L-arginine, L-arginine/SDMA, L-arginine/ADMA and L-arginine/SDMA+ADMA. Cr production was calculated using the Mitch formula (Mitch et al. Nephron 1978;21:248). T-Test was used to compare differences between women and men. Multivariate linear regression analysis was performed to determine predictors of renal biomarkers; a P value of 0.05 was considered significant. Results: The mean estimated Cr production was significantly lower in women than in men (14.50 ± 1.36 vs ± 1.90 mg/kg/day, P<0.0001). The mean serum Cr was also significantly lower in women than in men (Table 1). Despite lower estimated Cr production and serum Cr in women, the mean mgfr did not differ between women and men, indicating that the MELD-Na score underestimated renal dysfunction in women. No significant differences between the genders were detected for any of the biomarkers of renal function (Table 1). Even after controlling for age, race, weight, height and mgfr, female gender was an independent predictor of serum Cr (P=0.003), but gender did not Page 25

26 predict cystatin C (P=0.169), beta-trace protein (P=0.463), beta-2 microglobulin (P=0.161), SDMA (P=0.184) and ADMA (P=0.044) levels (Table 2). Conclusions: Reduction of estimated Cr production in women with cirrhosis contributes to significantly lower serum Cr levels in women with cirrhosis compared to men with cirrhosis with comparable mgfr. This gender difference in serum Cr results in lower MELD-Na scores in women with cirrhosis that underestimate the degree of their renal dysfunction, retard their access to OLT and significantly increase women s mortality on the waiting list. The discriminatory disadvantage for women listed for liver transplantation can be eliminated by revision of the MELD-Na score using either a more accurate estimate of GFR or gender-neutral biomarkers of renal function. TABLE: Table 1. Serum Cr and gender-neutral biomarkers of renal function in patients with cirrhosis GFR and GFR Biomarker Women Men.. Mean Value Mean Value P Value GFR (ml/min/1.73m 2 ) Cr (mg/dl) Cystatin C (mg/l) Beta-trace protein (mg/l) Beta-2 microglobulin (mg/l) SDMA (micromole/l) ADMA (micromole/l) SDMA+ADMA (micromole/l) L-arginine (micromole/l) L-arginine/SDMA L-arginine/ADMA L- arginine/(sdma+ad MA) Page 26

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