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BACKGROUND AND AIM Although oral mesalamine is the first-choice drug for treating mild-to-moderate ulcerative colitis (UC), some patients show symptoms of intolerance, including exacerbation of diarrhea and abdominal pain. The present study clarified the current state and clinical courses of patients with mesalamine intolerance. METHODS Patients who were diagnosed with UC and administered oral mesalamine at eight hospitals in Japan with a follow-up period exceeding 1 year were analyzed. RESULTS Sixty-seven (11%) of 633 patients showed intolerance to at least one formulation of oral mesalamine. The frequency of mesalamine intolerance has increased in recent years, rising from 5.3% in 2007-2010 to 9.1% in 2011-2013 and 16.2% in 2014-2016. The most common complications were the exacerbation of diarrhea (n = 29), a fever (n = 25), and abdominal pain (n = 22). Readministration of mesalamine/sulfasalazine was attempted in 43 patients, mostly with other types of formulation of mesalamine, and more than half of these patients proved to be tolerant. The risk factors for mesalamine intolerance were female gender (odds ratio [OR] = 1.83; 95% confidence interval [CI], 1.08-3.12), age

Objectives There is no standard chemotherapy for advanced pancreatic cancer (APC) after gemcitabine plus nab-paclitaxel (GP) failure. The aim of this study was to evaluate the efficacy and safety of FOLFIRINOX (5-Fluorouracil, leucovorin, irinotecan, and oxaliplatin) (5-Fluorouracil, leucovorin, irinotecan, and oxaliplatin) (FFX) and modified FFX (mFFX) for APC patients after GP failure. Methods We retrospectively evaluated the efficacy and safety of FFX in APC patients who were refractory or intolerant of GP. Results Between July 2014 and October 2018, 23 patients received FFX after failure of GP. The overall response rate (RR) was 23%, and the disease control rate (DCR) was 68%. The median progression-free survival (PFS) was 5.3 months (95% confidence interval, 2.5-8.9), and the median overall survival (OS) was 12.1 months (95% confidence interval, 4.0-14.2). Twelve patients received FFX, and 11 patients received mFFX. In the FFX group, the RR was 9%, the DCR was 73%, the PFS was 5.3 months, and the OS was 6.9 months. In the mFFX group, the RR was 23%, the DCR was 64%, the PFS was 4.3 months, and the OS was 12.8 months. There was no significant difference between the groups. Conclusions FOLFIRINOX has potential activity for patients with APC in whom GP failed.

Takotsubo cardiomyopathy (TCM) is also known as stress-induced cardiomyopathy. The occurrence of TCM due to infusion reaction is extremely rare. A 65-year-old man began receiving trastuzumab monotherapy for gastric cancer. However, he developed an infusion reaction after administration. Electrocardiography revealed negative T waves, ST segment elevation, and apical akinesis and hypokinesis of the left ventricle with apical ballooning in the systole and diastole. Furthermore, troponin I and creatinine kinase (CK) levels and CK-myocardial band were elevated. Based on these findings, he was diagnosed with TCM. This is the first report of TCM due to an infusion reaction.

391 Background: Nivolumab has changed the treatment of advanced gastric cancer (AGC). Nivolumab shows better outcome compared to best supportive care in AGC patients who received at least two prior regimen. Although there is not reliable date of poor performance status(PS) AGC patients who received nivolumab. We investigated efficacy and safety of nivolumab for AGC patients with poor PS. Methods: We retrospectively collected clinicopathologic data from patients with AGC who received nivolumab monotherapy in Himeji Red Cross Hospital from October 2017 to June 2019. Results: 49 AGC patients who received nivolumab were analyzed. 27 patients were PS 0 or 1(Good Group), and 22 patients were PS 2 or 3(Poor Group). Median progression free survival and overall survival was 61 days and 180 days in Good Group and 36 days and 85 days in Poor Group. Overall survival (OS) was significantly shorter in Poor group(180 days vs 85 days, p = 0.0255). Disease control rate was 23% in Good group and 9% in Poor group. 33% patients were experienced immune related adverse event (iRAE) in Good Group, and 18% in Poor Group. We investigated prognostic factor of OS in Poor Group such as Royal Marsden Hospital Score(RMH score), modified Glasgow prognostic score(mGPS), and Japan Clinical Oncology Group (JCOG) prognostic index. RMH score and JCOG prognostic index good or moderate group was significantly longer overall survival than poor group (93 days vs 35 days (p = 0.0214)). JCOG prognostic index was most correlated with OS among these tools. Conclusions: This study suggested that nivolumab has a modest effect and is feasible as third line or later line for AGC patients. JCOG prognostic index was suggested to be effective in predicting prognosis in AGC patients who received nivolumab.

Background and aim Although previous studies compared the efficacy of infliximab (IFX) versus adalimumab (ADA) as the first-line biologics for Crohn's disease (CD), the difference in long-term prognosis based on which biologic was used first has scarcely been reported. In particular, the clinical courses after loss of response (LOR) of the first-line biologics are largely unknown. Methods A multicenter, retrospective study was performed. Disease courses of biologic-naive CD patients who were started on IFX or ADA treatment were evaluated, even after LOR of the initial biologics. Results In total, 263 CD patients were eligible for analysis, 183 were treated with IFX first, and 80 were treated with ADA first. The median observation period was 64.2 months. The cumulative steroid-free remission rates and surgery-free rates did not differ significantly between the patients treated with IFX first and those treated with ADA first (log-rank test P = 0.42 and P = 0.74, respectively). In addition, no significant difference was observed in the rate of occurrence of events associated with ineffectiveness (modification of anti-tumor necrosis factor treatment including intensification, switch, discontinuation, or surgery) between the patient groups (log-rank test P = 0.62). The patients treated with IFX first were likely to discontinue the agent due to adverse events, whereas those treated with ADA first were likely to discontinue due to treatment failure or LOR. Conclusions No significant difference was observed in the long-term prognosis between biologic-naive patients with CD who were started treatment with IFX first and ADA first.

The INSOL 8 Principles is a set of model domestic rules for out-of-court workouts. Many Asian countries have created workout rules referring to the Principles. A uniform insolvency code applicable worldwide may be impossible to achieve. Instead, international professional associations such as the INSOL International and/or official international organizations such as the World Bank may be able to establish global informal workout rules that are applicable in cases to restructure multinational business enterprises that are indebted to multinational financial creditors. The “Asian Bankers' Association Informal Workout Guidelines” and the “Model Agreement to Promote Company Restructuring by Informal Workout” of 2005 are buried treasure tools. They could be transformed to global rules with some minor amendments with the consent of the Association. Copyright © 2013 INSOL International and John Wiley & Sons, Ltd

e22189Background: Place of death is widely known that it is important factor for quality of life of advanced cancer patients and caregivers. Although there are few studies that examine gastrointest...

As a basic principle, subject to defined exceptions, the effects of a bankruptcy proceeding commenced under Chapter 15 should be restricted to assets of the debtor located within the territorial jurisdiction of the United States. But Section 1528 provides broader exceptions to the above-mentioned principle than those stated in Article 28 of the UNCITRAL Model Law. Using the Yukos and Maruko cases as illustrations, the author concludes that U.S. judges should exercise their jurisdictional powers conservatively and American courts should be careful not to appear to export their own system of justice abroad. Copyright © 2007 John Wiley & Sons, Ltd.

The Industrial Revitalization Corporation of Japan (IRCJ) was created in 2003 to restructure distressed debtor corporations with excessive debts before their bankruptcy with a view to deterring ever-increasing non- and poor-performing loans. The IRCJ successfully reorganized target debtor companies through the out-of-court workout with multiple financial institutions where unanimous consent of financial creditors is required. Since the lifetime of the IRCJ is limited, the IRCJ cannot rescue troubled corporations after the end of March 2005. From then onward, the out-of-court workout should be utilized more widely in Japan in order to revitalize distressed businesses at an early stage without impairing the rights of trade creditors and deteriorating the value of the businesses. To make the workout most effective, it is important to ensure that the statutory reorganization The Industrial Revitalization Corporation of Japan (IRCJ) was created in 2003 to restructure distressed debtor corporations with excessive debts before their bankruptcy with a view to deterring ever-increasing non- and poor-performing loans. The IRCJ successfully reorganized target debtor companies through the out-of-court workout with multiple financial institutions where unanimous consent of financial creditors is required. Since the lifetime of the IRCJ is limited, the IRCJ cannot rescue troubled corporations after the end of March 2005. From then onward, the out-of-court workout should be utilized more widely in Japan in order to revitalize distressed businesses at an early stage without impairing the rights of trade creditors and deteriorating the value of the businesses. To make the workout most effective, it is important to ensure that the statutory reorganization procedures, including the majority rule, are applied more flexibly and reliably

The hepatitis B virus (HBV) gene has been detected in hepatocellular carcinoma (HCC) tissue negative for the hepatitis B surface antigen and positive for the hepatitis C virus (HCV) antibody, but the precise role of the HBV gene in hepatocarcinogenesis has yet to be clarified. We studied the HBV gene in liver tissue several years before the emergence of HCC. Eleven patients diagnosed with HCV-positive chronic liver disease and who developed HCC were assigned to group A. HBV DNA was detected in 8 of the 11 patients (73%). Twenty-five patients, who did not develop HCC, were selected as group B. Six of the group B patients were classified as DNA-positive (24%). The HBV DNA in liver tissue was found to be significantly related to HCC development (P < 0.01). Thus, the presence of the HBV gene in patients with chronic HCV associated-liver injury appears to promote hepatocarcinogenesis, although prospective studies are needed to confirm this result.

The preS2 region of the hepatitis B virus (HBV) has been reported to have human polymerized albumin receptor (PAR) activity, which correlates with viral replication. Here, we studied the genomic sequence of the preS region from rare patients lacking PAR activity, despite active viral replication. PAR and DNA polymerase activity was identified in 178 HBe antigen-positive HBV carriers, and a significant correlation between 2 markers was shown, except in 2 hepatitis patients lacking PAR activity. Nucleotide sequences of the preS region of HBV from both patients were examined by direct sequencing of PCR products. In one patient, a 45-base deletion was found to overlap half of the putative polymerized human albumin binding site in the preS2 region. In the other patient, a point mutation at the first nucleotide of the start codon of the preS2 region of HBV was found. There was no such genomic change in the 3 control HBV sequences. These results indicate that the preS2 region is necessary for binding of polymerized human albumin, and this is the first report of naturally existing mutant virus with no or low PAR activity.

Two persistent questions of enterprise law are raised and addressed: First, how does law matter to business practice? Second, how can we make law that stimulates economic efficiency? These questions are difficult to answer because of two important complementarities: the complementarity between areas of law within a country’s legal regime and the complementarity between law and other social environments such as markets and social norms. Over the course of the two-day conference, academics and practitioners from the U.S. and Japan in the areas of corporate law, securities regulation, labor law (including both employment protection law and labor union law), bankruptcy law, and tax law investigate the ways that enterprise law affects practice complementarily with markets and social norms. A key analytical framework is introduced, in which the business enterprise is viewed as an incentive mechanism among the four indispensable capital providers of the firm: management, employees, shareholders, and creditors. Only through close attention to the incentive bargain between these four players can optimal legislative design and economic efficiency be achieved.

In 2000, Japan enacted the Law of Recognition and Assistance for Foreign Insolvency Proceedings (LRAFIP) which adopted almost all the provisions of the UNCITRAL Model Law on Cross-Border Insolvency, and abolished the notorious territorialism contained in Japanese insolvency laws for so many years. Since the LRAFIP became effective in 2002, only two cases have been filed (one by a foreign trustee and the other by a debtor in possession), calling for recognition and assistance under the LRAFIP.

A 68-year-old man underwent cholecystectomy and choledochoduodenostomy for biliary obstruction and nephrectomy for a renal tumor. Based on clinical and histopathologic findings, autoimmune pancreatitis (AIP) was diagnosed. The renal tumor was diagnosed as a renal cell cancer. Steroid therapy was started and thereafter pancreatic inflammation improved. Five years after surgery, the patient was readmitted because of pyrexia in a preshock state. A Klebsiella pneumoniae liver abscess complicated by sepsis was diagnosed. The patient recovered with percutaneous abscess drainage and administration of intravenous antibiotics. Liver abscess recurred 1 mo later but was successfully treated with antibiotics. There has been little information on long-term outcomes of patients with AIP treated with surgery. To our knowledge, this is the second case of liver abscess after surgical treatment of AIP.

Autoimmune hepatitis shows a good response to immunosuppressive treatment, and the prognosis may be determined by the clinical course. The present study was conducted in order to analyze the factors contributing to the outcomes of patients with type 1 autoimmune hepatitis.Eighty-four consecutive patients with type 1 autoimmune hepatitis were followed up regularly for a median follow-up period of 70.5 months (16.2-163 months). We analyzed the prognostic factors using time-fixed and time-dependent Cox proportional hazard models. The end point was progression of the disease to decompensated liver cirrhosis.Seventy-seven patients (92%) were treated with prednisolone during the follow-up period, and 11 patients (13%) developed decompensated liver cirrhosis. Using a time-dependent multivariate model, the starting dose of corticosteroid (dose of prednisolone20 mg/day), relapse within 3 months after the normalization of serum alanine aminotransferase levels with initial treatment, and elevated serum alanine aminotransferase levels during the follow-up period (40 IU/L), all showed a significant association with progression of the disease.The prognosis of type 1 autoimmune hepatitis on adequate immunosuppressive treatment improves when the serum alanine aminotransferase level persists ator = 40 IU/L. Factors existing prior to medical treatment may not affect the prognosis.

The hepatitis B virus (HBV) gene has been detected in hepatocellular carcinoma (HCC) tissue negative for the hepatitis B surface antigen and positive for the hepatitis C virus (HCV) antibody, but the precise role of the HBV gene in hepatocarcinogenesis has yet to be clarified. We studied the HBV gene in liver tissue several years before the emergence of HCC. Eleven patients diagnosed with HCV-positive chronic liver disease and who developed HCC were assigned to group A. HBV DNA was detected in 8 of the 11 patients (73%). Twenty-five patients, who did not develop HCC, were selected as group B. Six of the group B patients were classified as DNA-positive (24%). The HBV DNA in liver tissue was found to be significantly related to HCC development (P0.01). Thus, the presence of the HBV gene in patients with chronic HCV associated-liver injury appears to promote hepatocarcinogenesis, although prospective studies are needed to confirm this result.