Risk of Pancreatitis Following Biliary Stenting With/Without Endoscopic Sphincterotomy: A Randomized Controlled Trial.

BACKGROUND & AIMS: The efficacy of endoscopic sphincterotomy (ES) before endoscopic transpapillary biliary drainage in preventing post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) has not been established. The aim of this study was to evaluate the effect of performing ES before biliary stent/tube placement on the occurrence of PEP. METHODS: Three hundred seventy patients with biliary stricture requiring endoscopic biliary stenting were enrolled and randomly allocated to the ES group (n = 185) or non-ES group (n = 185). All participants were followed up for 30 days after the procedure. The data and occurrence of adverse events were prospectively collected. The primary outcome measure of this study was the incidence of PEP within 2 days of initial transpapillary biliary drainage. Secondary outcome measures were the incidence of other adverse events related to biliary stent/tube placement. RESULTS: PEP occurred in 36 patients (20.6%) in the non-ES group and in 7 patients (3.9%) in the ES group (P < .001). The difference in the incidence of PEP between the 2 groups in the per-protocol population was 16.7% (95% confidence interval, 10.1%-23.3%), which was not within the noninferiority margin of 6%. Except for bleeding, the incidences of other adverse events were not significantly different between the groups. CONCLUSION: ES before endoscopic biliary stenting could have the preventive effect on the occurrence of PEP in patients with biliary stricture. University Hospital Medical Information Network Number, UMIN000025727.University Hospital Medical Information Network Clinical Trial Registry URL: https://www.umin.ac.jp/ctr/index.htm.

Clinical usefulness of biochemical markers of liver fibrosis in patients with nonalcoholic fatty liver disease.

AIM: Nonalcoholic steatohepatitis (NASH) is a severe form of nonalcoholic fatty liver disease (NAFLD), and progresses to the end stage of liver disease. Biochemical markers of liver fibrosis are strongly associated with the degree of histological liver fibrosis in patients with chronic liver disease. However, data are few on the usefulness of markers in NAFLD patients. The aim of this study was to identify better noninvasive predictors of hepatic fibrosis, with special focus on markers of liver fibrosis, type VI collagen 7S domain and hyaluronic acid. METHODS: One hundred and twelve patients with histologically proven NAFLD were studied. RESULTS: The histological stage of NAFLD correlated with several clinical and biochemical variables, the extent of hepatic fibrosis and the markers of liver fibrosis were relatively strong associated. The best cutoff values to detect NASH were assessed by using receiver operating characteristic analysis: type VI collagen 7S domain > or =5.0 ng/mL, hyaluronic acid > or =43 ng/mL. Both markers had a high positive predictive value: type VI collagen 7S domain, 86% and hyaluronic acid, 92%. Diagnostic accuracies of these markers were evaluated to detect severe fibrosis. Both markers showed high negative predictive values: type VI collagen 7S domain (> or =5.0 ng/mL), 84% and hyaluronic acid (> or =50 ng/mL), 78%, and were significantly and independently associated with the presence of NASH or severe fibrosis by logistic regression analysis. CONCLUSION: Both markers of liver fibrosis are useful in discriminating NASH from fatty liver alone or patients with severe fibrosis from patients with non-severe fibrosis.

Metabolic syndrome is directly associated with gamma glutamyl transpeptidase elevation in Japanese women.

AIM: This study aimed to determine whether metabolic syndrome is directly or indirectly, through fatty liver, associated with elevated gamma-glutamyl transpeptidase (GGT) levels in Japanese women. METHODS: From 4 366 women who received their annual health check-up, 4 211 women were selected for analysis. All 4 211 women were negative for both hepatitis B surface antigen and antibody to hepatitis C virus. Clinical and biochemical variables were examined by using univariate and multivariate analysis. RESULTS: A raised GGT level (>68 IU/L) was seen in 258 (6.1%) of the 4 211 women. In univariate analysis, all variables examined (age, body mass index, blood pressure, hemoglobin concentration, fasting blood glucose, glycosylated hemoglobin A1c, cholesterol, triglyceride, and uric acid) were associated with the elevated GGT level, whereas in multivariate analysis, four variables (age > or =50 yr, hemoglobin > or =14 g/dL, triglyceride > or =150 mg/dL, and presence of diabetes) were significantly and independently associated with raised GGT level. Clinical variables predicting the presence of ultrasonographic evidence of fatty liver were also examined by multivariate analysis; four variables were associated with the presence of fatty liver: BMI > or =25 kg/m(2), hemoglobin > or =14 g/dL, triglyceride > or =150 mg/dL, and uric acid > or =7 mg/dL. There was no significant association between the raised GGT level and the presence of fatty liver. Hypertriglyceridemia was significantly and independently associated with both the raised GGT level and the presence of fatty liver. CONCLUSION: Metabolic syndrome seemed to be directly, not indirectly through fatty liver, associated with the raised GGT level in Japanese women.

Clinical characteristics of patients with cryptogenic liver cirrhosis in Okinawa, Japan.

BACKGROUND/AIMS: The aims of the present study were to determine the prevalence of patients with cryptogenic liver cirrhosis, and to clarify the clinical characteristics of these patients, with special focus on obesity and type 2 diabetes mellitus. METHODOLOGY: For the case-control study, we selected age- and sex-matched control patients with cirrhosis of known etiology. RESULTS: Of 404 patients with liver cirrhosis, 40 (9.9%) were diagnosed as having cryptogenic cirrhosis. Of these 40 patients, 29 (73%) were female. The mean age was 66.1 +/- 8.9 (range 40-87 years old), and was significantly higher than that of either virus, or alcohol-related liver cirrhosis patients. Both obesity and type 2 diabetes mellitus were more common in patients with cryptogenic cirrhosis (53% and 40%, respectively) compared with the case-controls (20%, 18%, respectively). CONCLUSIONS: Cryptogenic liver cirrhosis accounted for approximately 10% of liver cirrhosis, and was associated with both obesity and type 2 diabetes mellitus. Nonalcoholic steatohepatitis sequelae may be the most important etiological factor in patients with cryptogenic liver cirrhosis in Okinawa, Japan, where virus-etiology is more predominant in liver cirrhosis compared with Western countries.

Monitoring low level hepatitis B virus by a newly developed sensitive test.

We have recently developed a sensitive quantitative test for hepatitis B virus (HBV) DNA using a real-time polymerase chain reaction (HBV RTD DIRECT), which can detect HBV DNA levels as low as 10(0.7) copies/ml. The aim of this study was to explore the significance of viremia changes below the detection limit of the other currently developed sensitive assays, transcription-mediated amplification and hybridization protection assay (TMA-HPA) and Amplicor HBV Monitor. The subjects consisted of 11 patients with chronic liver disease type B who showed undetectable test results of HBV DNA by TMA-HPA or Amplicor HBV Monitor during the observation period. A total of 150 serial serum samples were examined for viremia level by HBV RTD DIRECT: 139 were positive and 11 were negative. HBV RTD DIRECT could detect viremia in 72 of 78 serum samples negative for HBV DNA by TMA-HPA, or in 38 of 43 serum samples negative for HBV DNA by Amplicor HBV Monitor. The HBV DNA level was gradually increased from its lowest level before the spontaneous reactivation of hepatitis or the emergence of YMDD mutant during lamivudine treatment. However, such a phenomenon was not revealed by either TMA-HPA or the Amplicor HBV Monitor test.

Epidemiology of primary biliary cirrhosis among women with elevated gamma-glutamyl transpeptidase levels in Okinawa, Japan.

We investigated the conditions among women who had an asymptomatic increase in serum gamma-glutamyl transpeptidase (gamma-GTP) levels, and the prevalence of primary biliary cirrhosis (PBC), in the general population. Among 4048 women who received their annual health check-up, 241 showed an elevated gamma-GTP level and were invited to participate in this study. Of the 241 women, 122 participated and were examined thoroughly, including for antimitochondrial antibody (AMA) and by using liver biopsy to make a clinical diagnosis. Six (4.9%) of the 122 women were AMA positive: five were diagnosed and one was suspected of having PBC. Another two women had the criteria of PBC despite being AMA negative. PBC was detected in 5.7% (95% confidence interval (CI), 1.6-9.9%) of asymptomatic women with raised gamma-GTP levels who were 6.0% of all 4048 women examined. The estimated prevalence of PBC in our area was 3400 per million women mainly over 40 years and 840 per million in the whole population. In 44% of women, the cause of chronic gamma-GTP elevation was unknown; they usually showed mild and non-specific histological change differing from their liver biochemical test results.