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1014 Endoscopic Ultrasound-Guided Fine Needle Aspiration of Focal Hepatic Lesions
acid substitutions in the NS5A region among patients with HCV genotype 1a, 1b, 2a, 2b, and 3a affect the response to pegylated-interferon-alpha 2b and ribavirin combination therapy. METHODS: Six hundred sixty-five patients with chronic hepatitis C were enrolled. There were 375 men and 290 women (mean age, 57.7 ± 13.5 years). HCV genotypes 1a (N = 18), 1b (N = 428), 2a (N = 137), 2b (N = 71), and 3a (N = 11) were detected. The NS5A region (IFN sensitivity-determining region (ISDR)) in each genotype was examined by direct sequencing. The proto-type for each genotype were defined and the counting the number of mutations to the sequence of proto-type in the ISDR and the strains which have more than two mutations were defined as mutant-type. Detection of the SNP of IL28B (rs8099917) was done by a real-time PCR system with specific probes. Patients received pegylated-IFNalpha 2b once each week plus oral ribavirin daily for 24 -72weeks. RESULTS: Of the 665 patients, 365 (54.9%) showed sustained virologic response (SVR). SVR rates according genotype 1a, 1b, 2a, 2b, and 3a were 44.4, 43.6, 72.9, 70.4, and 80.1%, respectively. Factors related to SVR in genotype 1a were IL28B TT allele (p=0.0359) and ISDR mutanttype (p=0.0229). The IL28B and mutation in the ISDR were the factors related to SVR on multivariate analysis in patients with genotype1b. The best SVR was achieved in patients with mutant-type ISDR and IL28B T allele (70.5%), and the worst was achieved in patients with wild-type ISDR and IL28B G allele (11.1%) in genotype 1a and 1b. Of the 137 patients, 100 (72.9%) achieved SVR in patients with genotype 2a. SVR was achieved in 65.5% of patients with wild-type ISDR and 86% of patients with mutant-type (p = 0.0097). Achievement of SVR occurred in patients with T allele (66.7%) and those with G allele (74.8%). There were no significant differences in SVR according to IL28B in genotype 2a. Similar results were found in genotype 2b. Both ISDR and IL28B in patients with genotype 3a were not associated with SVR. CONCLUSIONS: Both ISDR and IL28B were significantly associated with SVR in genotype 1a and 1b. Only ISDR was useful for predicting the IFN response in genotype 2a and 2b. The impact of ISDR and IL28B on SVR was different in each genotype and these concepts should consider in choosing optimal therapy.
1014
Gastrointestinal tumors are the leading cause of liver metastases. EUS allows staging of gastrointestinal neoplasm and fine needle aspiration of focal hepatic lesions which could influence the final management of these patients. Objective: To evaluate the utility and safety of endoscopic ultrasound fine needle aspiration(EUS-FNA) in focal hepatic lesions. Patients and Methods: 31 patients with malignant gastrointestinal neoplasm referred for EUS evaluation from 2005 to 2011, in which focal hepatic lesions were detected and EUS-FNA was performed using Wilson Cook needle with 22 gauges with FG32UA Pentax and Olympus GF-UCT140 echoendoscopes. Results: Primary pathologies distributed: 15 pancreatic tumors, 7 hepatic tumors, 2 gastroesophageal junction cancer, 1 esophageal tumor, 2 Gallbladder neoplasm, 2 cholangiocarcinoma and 2 adenomegalic syndromes, all had liver EUS-FNA. The size of the focal liver lesion measured between 4 and 35 mm. 18/31 lesions smaller than 10 mm (58.06%) and greater than 10 mm 13/31 (41.93%). Those under 10 mm were malignant in 15/18 (83.33%) and 3 / 18 (16.66%) were negative. Those greater than 10 mm were malignant in 11/13 (84.61%) and 2 / 13 (15.38%) were negative. Endoscopic ultrasound features were: 6 / 31 (19.35%) hyperechoic, 17/31 (54.84%) hypoechoic and 8 / 31 (25.81%) mixed. Conclusions: The echoendoscope is able to detect small focal hepatic lesions unsuspected by other methods. The EUS-FNA is a reliable and safe method that can confirm the diagnosis of liver metastases and establish M staging, which changes the clinical management required to receive neoadjuvant therapy. In patients with malignant GI tumors, metastasis must be ruled out in the presence of focal hepatic lesions, regardless of the size and characteristics.
942 The Effect of Peginterferon ALPHA-2A vs. Peginterferon alpha-2B in Treatment of NaïVE Chronic HCV Genotype-4 Patients: A Cohort Egyptian Study Waleed Fathalla, Wafaa El-Akel, Ahmad Salama, Gamal Esmat, Mahasen Mabrouk BACKGROUND: Egypt has one of the highest (16 - 18%) prevalence rates of HCV infection in the world. Approximately 90% of Egyptian HCV isolates belong to a single subtype (4a), which responds less successfully to interferon therapy than other subtypes. Studies comparing the efficacy and safety of PEGIFN alfa-2a and PEGIFN alfa-2b in treatment-naïve HCVinfected patients have shown conflicting results. AIM: assessing the effects of Peginterferon alpha-2a versus Peginterferon alpha-2b on the Sustained Virological Response in naïve chronic HCV genotype-4 patients. METHODS: this retrospective study cohort consists of 3719 chronic HCV patients enrolled in a large, Egyptian centre (El Fatamyia Hospital), 1985 patients had been treated with PEG-IFN alfa-2a & 1733 patients with PEG-IFN alfa-2b plus RBV between years 2008-2010. Efficacy outcomes were sustained virologic response (SVR) and treatment discontinuation rates due to serious adverse effects. RESULTS: Pooled data on outcomes (reported as odds ratios [ORs] with 95% confidence intervals [CIs]) showed no difference in SVR in patients treated with PEGIFN alfa-2a (56%) as compared to treatment with PEGIFN alfa-2b (53%) [1.12 (0.99-1.28); P = 0.078]. Treatment discontinuation rates, were similar in the two types of PEGIFN [0.66 (0.37-1.16); P = 0.15]. Univariate logistic regression analysis showed that low AFP levels and male gender,were the most significant predictors of response for PEGIFN alfa-2a or 2b (P <0.001). SVR results obtained with the two types of IFN showed no impact of viral load CONCLUSIONS: PEGIFN alfa-2a has similar efficacy as regard SVR as compared to PEGIFN alfa-2b in treatment of naïve HCVinfected patients. The safety profile of the two types of PEGIFN was similar.
1015 Needle Track Seeding of Hepatocellular Cancer After Liver Transplant Can Be Devastating Kristi T. Lopez, Linda L. Wong, Scott K. Kuwada Background: Seeding of hepatocellular cancer (HCC) has been described in up to 5% of patients who undergo liver biopsy and 12.5% of those undergoing radiofrequency ablation (RFA) of HCC. Liberal use of liver biopsy has recently been advocated in small liver masses in which clinical features are not otherwise diagnostic. Methods: A database of 759 HCC patients referred to a tertiary center for liver disease/transplant between 1993 and 2011 was used to identify patients who had liver biopsy for diagnosis of HCC and patients who underwent percutaneous RFA. In this cohort, 150 patients underwent liver resection and 63 patients underwent liver transplant. Cases of needle track seeding were reviewed in detail. Results: In this study, 329 patients underwent percutaneous liver biopsy to diagnose HCC and 191 patients received 231 sessions of RFA. Needle track seeding to the chest wall/ lung was seen in 5 patients (1.5%): 3 patients who underwent liver resection and 2 who had RFA prior to liver transplant. The first patient had a 2.1 cm lesion that was biopsied and subsequently treated with RFA. She developed a chest wall mass 7 months post transplant and 13 months after the biopsy and RFA. This was resected and she was treated with sorafenib, but eventually expired 18 months post transplant due to metastatic disesase. The second patient had a 2.3 cm HCC diagnosed by biopsy, then had 2 sessions of RFA before transplant. He underwent liver transplant 7 months after the biopsy and 3 months after the last RFA session. He developed small chest wall masses at the biopsy/RFA site (1.0 cm, 2.4 cm) 4 years and 6 years post transplant and then developed extensive chest wall/rib/ diaphragm masses 9 years post transplant. He is now undergoing radiation therapy. Needle track seeding after biopsy occurred in 3 of 95 patients (3.2%) who underwent liver resection and 2 of 34 patients (5.9%) who underwent liver transplant. Zero of 171 patients who underwent RFA alone had needle track seeding compared to 2 of 20 patients (10%) who underwent RFA followed by liver transplant. Nineteen patients had both liver biopsy and RFA prior to transplant, 2 of the 12 patients who had biopsy and RFA done at separate sessions had needle track seeding, while 0 of 7 patients who had the biopsy and RFA done at the same time developed this complication. Conclusions: Although the incidence of needle track seeding was 1.5% after biopsy and 1.0 % after RFA, this can be a devastating complication and can potentially change a curative therapy such as transplant into a noncurative one. Immunosuppression may also be a factor in tumor recurrence in this population. Transplant physicians should be cautious in choosing liver biopsy and percutaneous RFA for suspected lesions, especially when they are done in separate sessions.
943 A Randomized Controlled Trial Adding Fluvastatin to Peginterferon and Ribavirin for Naive Genotype One Hepatitis C Patients Ted Bader, L Diane Hughes, Monica Dunnam, Belinda Frost, Andrea Gonterman, Javid Fazili, Mohammad F. Madhoun Background: We have shown the most active dose of fluvastatin (FLV) as an anti-HCV agent in humans to be 20 mg/day (Am J Gastro 2008; 103:1383-9). FLV and interferon are synergistic as anti-HCV agents In Vitro (Hepatology 2006;44:117-25). Statins improve ALT values in HCV carriers (Dig Dis Sci 2010;55:870-1) (Bader, J Hepatology 2011, epub). Voluminous data support that statins are not hepatotoxic (Am J Gastro 2010;105:978-80). Methods: Forty-four naive to treatment genotype one HCV patients were randomized to a control group (n=19) to receive peginterferon alfa 2a or 2b at standard weekly doses plus 1,000 to 1,200 mg ribavirin (RBV) per day. The experimental arm provided peginterferon alfa plus RBV in a similar manner but also received FLV 20 mg/day in an open label format (n=18). In addition, 7 patients presented for HCV treatment already on simvastatin (SIM) for their hypercholesterolemia and could not be exposed to withdrawal. These were entered into a concurrent prospective pilot arm and analyzed together with the FLV group. The dose range used for SIM was 10-80 mg/day. Results: See table for efficacy. There were no safety issues with FLV or SIM when given concurrently with peginterferon plus RBV for 48 weeks. Conclusions: In this small randomized controlled trial, fluvastatin and simvastatin caused an improvement in sustained viral remission (SVR) when administered with peginterferon/RBV. Importantly, there were no safety issues with the addition of fluvastatin or simvastatin for 48 weeks. These results mirror the significant results of another randomized controlled trial of fluvastatin at 20mg/day combined with peginterferon plus RBV in 209 patients (J Hepatol 2010;52(Suppl 1):S110). RCT peginterferon/RBV +/- statin
1016 Risk of Hepatic Artery and Biliary Complications in Liver Transplant Recipients Treated With Transarterial Chemoembolization Neil Mehta, Aparna Goel, Karen C. Bagatelos, James L. Buxbaum, Nicholas Fidelman, John P. Roberts, Norah A. Terrault, Francis Yao, James W. Ostroff Purpose: Hepatic artery (HAC) and biliary (BC) complications are relatively common and important causes of post-liver transplant morbidity. Due to possible effects on the hepatic vasculature, pre-transplant TACE may increase the frequency of these complications. We aimed to investigate the effect of TACE on post-transplant HAC and BC, and the specific donor or recipient factors modifying this association. Methods: We performed a single center retrospective cohort study of liver transplant recipients (LT-R) from 2002-2008. We
S-939
AASLD Abstracts
AASLD Abstracts
Endoscopic Ultrasound-Guided Fine Needle Aspiration of Focal Hepatic Lesions Dervis J. Bandres, Mitsuko Nishimura, Maria V. Bandres, Marielaure Garcia, Lucy Dagher, Julia Lippolis
1014
Gastrointestinal tumors are the leading cause of liver metastases. EUS allows staging of gastrointestinal neoplasm and fine needle aspiration of focal hepatic lesions which could influence the final management of these patients. Objective: To evaluate the utility and safety of endoscopic ultrasound fine needle aspiration(EUS-FNA) in focal hepatic lesions. Patients and Methods: 31 patients with malignant gastrointestinal neoplasm referred for EUS evaluation from 2005 to 2011, in which focal hepatic lesions were detected and EUS-FNA was performed using Wilson Cook needle with 22 gauges with FG32UA Pentax and Olympus GF-UCT140 echoendoscopes. Results: Primary pathologies distributed: 15 pancreatic tumors, 7 hepatic tumors, 2 gastroesophageal junction cancer, 1 esophageal tumor, 2 Gallbladder neoplasm, 2 cholangiocarcinoma and 2 adenomegalic syndromes, all had liver EUS-FNA. The size of the focal liver lesion measured between 4 and 35 mm. 18/31 lesions smaller than 10 mm (58.06%) and greater than 10 mm 13/31 (41.93%). Those under 10 mm were malignant in 15/18 (83.33%) and 3 / 18 (16.66%) were negative. Those greater than 10 mm were malignant in 11/13 (84.61%) and 2 / 13 (15.38%) were negative. Endoscopic ultrasound features were: 6 / 31 (19.35%) hyperechoic, 17/31 (54.84%) hypoechoic and 8 / 31 (25.81%) mixed. Conclusions: The echoendoscope is able to detect small focal hepatic lesions unsuspected by other methods. The EUS-FNA is a reliable and safe method that can confirm the diagnosis of liver metastases and establish M staging, which changes the clinical management required to receive neoadjuvant therapy. In patients with malignant GI tumors, metastasis must be ruled out in the presence of focal hepatic lesions, regardless of the size and characteristics.
942 The Effect of Peginterferon ALPHA-2A vs. Peginterferon alpha-2B in Treatment of NaïVE Chronic HCV Genotype-4 Patients: A Cohort Egyptian Study Waleed Fathalla, Wafaa El-Akel, Ahmad Salama, Gamal Esmat, Mahasen Mabrouk BACKGROUND: Egypt has one of the highest (16 - 18%) prevalence rates of HCV infection in the world. Approximately 90% of Egyptian HCV isolates belong to a single subtype (4a), which responds less successfully to interferon therapy than other subtypes. Studies comparing the efficacy and safety of PEGIFN alfa-2a and PEGIFN alfa-2b in treatment-naïve HCVinfected patients have shown conflicting results. AIM: assessing the effects of Peginterferon alpha-2a versus Peginterferon alpha-2b on the Sustained Virological Response in naïve chronic HCV genotype-4 patients. METHODS: this retrospective study cohort consists of 3719 chronic HCV patients enrolled in a large, Egyptian centre (El Fatamyia Hospital), 1985 patients had been treated with PEG-IFN alfa-2a & 1733 patients with PEG-IFN alfa-2b plus RBV between years 2008-2010. Efficacy outcomes were sustained virologic response (SVR) and treatment discontinuation rates due to serious adverse effects. RESULTS: Pooled data on outcomes (reported as odds ratios [ORs] with 95% confidence intervals [CIs]) showed no difference in SVR in patients treated with PEGIFN alfa-2a (56%) as compared to treatment with PEGIFN alfa-2b (53%) [1.12 (0.99-1.28); P = 0.078]. Treatment discontinuation rates, were similar in the two types of PEGIFN [0.66 (0.37-1.16); P = 0.15]. Univariate logistic regression analysis showed that low AFP levels and male gender,were the most significant predictors of response for PEGIFN alfa-2a or 2b (P <0.001). SVR results obtained with the two types of IFN showed no impact of viral load CONCLUSIONS: PEGIFN alfa-2a has similar efficacy as regard SVR as compared to PEGIFN alfa-2b in treatment of naïve HCVinfected patients. The safety profile of the two types of PEGIFN was similar.
1015 Needle Track Seeding of Hepatocellular Cancer After Liver Transplant Can Be Devastating Kristi T. Lopez, Linda L. Wong, Scott K. Kuwada Background: Seeding of hepatocellular cancer (HCC) has been described in up to 5% of patients who undergo liver biopsy and 12.5% of those undergoing radiofrequency ablation (RFA) of HCC. Liberal use of liver biopsy has recently been advocated in small liver masses in which clinical features are not otherwise diagnostic. Methods: A database of 759 HCC patients referred to a tertiary center for liver disease/transplant between 1993 and 2011 was used to identify patients who had liver biopsy for diagnosis of HCC and patients who underwent percutaneous RFA. In this cohort, 150 patients underwent liver resection and 63 patients underwent liver transplant. Cases of needle track seeding were reviewed in detail. Results: In this study, 329 patients underwent percutaneous liver biopsy to diagnose HCC and 191 patients received 231 sessions of RFA. Needle track seeding to the chest wall/ lung was seen in 5 patients (1.5%): 3 patients who underwent liver resection and 2 who had RFA prior to liver transplant. The first patient had a 2.1 cm lesion that was biopsied and subsequently treated with RFA. She developed a chest wall mass 7 months post transplant and 13 months after the biopsy and RFA. This was resected and she was treated with sorafenib, but eventually expired 18 months post transplant due to metastatic disesase. The second patient had a 2.3 cm HCC diagnosed by biopsy, then had 2 sessions of RFA before transplant. He underwent liver transplant 7 months after the biopsy and 3 months after the last RFA session. He developed small chest wall masses at the biopsy/RFA site (1.0 cm, 2.4 cm) 4 years and 6 years post transplant and then developed extensive chest wall/rib/ diaphragm masses 9 years post transplant. He is now undergoing radiation therapy. Needle track seeding after biopsy occurred in 3 of 95 patients (3.2%) who underwent liver resection and 2 of 34 patients (5.9%) who underwent liver transplant. Zero of 171 patients who underwent RFA alone had needle track seeding compared to 2 of 20 patients (10%) who underwent RFA followed by liver transplant. Nineteen patients had both liver biopsy and RFA prior to transplant, 2 of the 12 patients who had biopsy and RFA done at separate sessions had needle track seeding, while 0 of 7 patients who had the biopsy and RFA done at the same time developed this complication. Conclusions: Although the incidence of needle track seeding was 1.5% after biopsy and 1.0 % after RFA, this can be a devastating complication and can potentially change a curative therapy such as transplant into a noncurative one. Immunosuppression may also be a factor in tumor recurrence in this population. Transplant physicians should be cautious in choosing liver biopsy and percutaneous RFA for suspected lesions, especially when they are done in separate sessions.
943 A Randomized Controlled Trial Adding Fluvastatin to Peginterferon and Ribavirin for Naive Genotype One Hepatitis C Patients Ted Bader, L Diane Hughes, Monica Dunnam, Belinda Frost, Andrea Gonterman, Javid Fazili, Mohammad F. Madhoun Background: We have shown the most active dose of fluvastatin (FLV) as an anti-HCV agent in humans to be 20 mg/day (Am J Gastro 2008; 103:1383-9). FLV and interferon are synergistic as anti-HCV agents In Vitro (Hepatology 2006;44:117-25). Statins improve ALT values in HCV carriers (Dig Dis Sci 2010;55:870-1) (Bader, J Hepatology 2011, epub). Voluminous data support that statins are not hepatotoxic (Am J Gastro 2010;105:978-80). Methods: Forty-four naive to treatment genotype one HCV patients were randomized to a control group (n=19) to receive peginterferon alfa 2a or 2b at standard weekly doses plus 1,000 to 1,200 mg ribavirin (RBV) per day. The experimental arm provided peginterferon alfa plus RBV in a similar manner but also received FLV 20 mg/day in an open label format (n=18). In addition, 7 patients presented for HCV treatment already on simvastatin (SIM) for their hypercholesterolemia and could not be exposed to withdrawal. These were entered into a concurrent prospective pilot arm and analyzed together with the FLV group. The dose range used for SIM was 10-80 mg/day. Results: See table for efficacy. There were no safety issues with FLV or SIM when given concurrently with peginterferon plus RBV for 48 weeks. Conclusions: In this small randomized controlled trial, fluvastatin and simvastatin caused an improvement in sustained viral remission (SVR) when administered with peginterferon/RBV. Importantly, there were no safety issues with the addition of fluvastatin or simvastatin for 48 weeks. These results mirror the significant results of another randomized controlled trial of fluvastatin at 20mg/day combined with peginterferon plus RBV in 209 patients (J Hepatol 2010;52(Suppl 1):S110). RCT peginterferon/RBV +/- statin
1016 Risk of Hepatic Artery and Biliary Complications in Liver Transplant Recipients Treated With Transarterial Chemoembolization Neil Mehta, Aparna Goel, Karen C. Bagatelos, James L. Buxbaum, Nicholas Fidelman, John P. Roberts, Norah A. Terrault, Francis Yao, James W. Ostroff Purpose: Hepatic artery (HAC) and biliary (BC) complications are relatively common and important causes of post-liver transplant morbidity. Due to possible effects on the hepatic vasculature, pre-transplant TACE may increase the frequency of these complications. We aimed to investigate the effect of TACE on post-transplant HAC and BC, and the specific donor or recipient factors modifying this association. Methods: We performed a single center retrospective cohort study of liver transplant recipients (LT-R) from 2002-2008. We
S-939
AASLD Abstracts
AASLD Abstracts
Endoscopic Ultrasound-Guided Fine Needle Aspiration of Focal Hepatic Lesions Dervis J. Bandres, Mitsuko Nishimura, Maria V. Bandres, Marielaure Garcia, Lucy Dagher, Julia Lippolis