Sapporo Kosei General Hospital

Chūō-ku, Japan

Sapporo Kosei General Hospital

Chūō-ku, Japan
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Ichihara S.,Sapporo Kosei General Hospital | Uedo N.,Japan National Cardiovascular Center Research Institute | Gotoda T.,Nihon University
Digestive Endoscopy | Year: 2017

Siewert's classification of adenocarcinoma of the esophagogastric junction (EGJ) classifies tumors anatomically for determining the appropriate surgical technique. According to this classification, a type II tumor, true carcinoma of the cardia, is defined as a cancer within 1 cm proximal to 2 cm distal of the EGJ. Histological analysis indicates that the cardiac gland is present with a high degree of frequency between 1–2 cm to the gastric side and 1–2 cm to the esophageal side of the EGJ, which means that this zone can be considered as neither the stomach nor the esophagus but rather as a third zone known as the ‘EGJ zone’. It has been suggested that there are multiple causes for development of adenocarcinoma in the EGJ zone. The TNM Classification of Malignant Tumours 7th Edition considers EGJ adenocarcinoma (EGJAC) occurring in the EGJ zone to be a part of esophageal adenocarcinoma (EAC). However, recent studies have indicated that EGJAC behaves differently from EAC and gastric carcinoma. Barrett's esophagus is now considered an important factor in the etiology of EGJAC, but, as yet, no studies have elucidated the differences between cancer arising from short-segment Barrett's esophagus and cancer of the gastric cardia. Thus, there is currently no clinical relevance to subdivision of adenocarcinoma in the EGJ zone into above or below the EGJ line. © 2017 The Authors. Digestive Endoscopy © 2017 Japan Gastroenterological Endoscopy Society


Kumada H.,Toranomon Hospital | Toyota J.,Sapporo Kosei General Hospital | Okanoue T.,Saiseikai Suita Hospital | Chayama K.,Hiroshima University | And 2 more authors.
Journal of Hepatology | Year: 2012

Background & Aims: To evaluate the efficacy and safety of telaprevir in combination with peginterferon-α2b (PEG-IFN) and ribavirin (RBV) in patients with chronic hepatitis C. Methods: In a multi-center randomized clinical trial in Japan, on patients infected with HCV of genotype 1, 126 patients were assigned to telaprevir for 12 weeks along with PEG-IFN and RBV for 24 weeks (Group A), while 63 to PEG-IFN and RBV for 48 weeks (Group B). Results: HCV RNA disappeared more swiftly in patients in Group A than B, and the frequency of patients without detectable HCV RNA at week 4 (rapid virological response (RVR)) was higher in Group A than B (84.0% vs. 4.8%, p <0.0001). Grade 3 and 4 skin disorders, including Stevens-Johnson syndrome and drug rashes with eosinophilia and systemic symptoms, as well as Grade 3 anemia (<8.0 g/dl), occurred more frequently in Group A than B (skin disorders, 11.9% vs. 4.8%; anemia, 11.1% vs. 0.0%). The total RBV dose was smaller in Group A than B (47.0% vs. 77.7% of the target, p <0.0001). Despite these drawbacks, sustained virological response (SVR) was achieved more frequently in Group A than B (73.0% vs. 49.2%, p = 0.0020). Conclusions: Although the triple therapy with telaprevir-based regimen for 24 weeks resulted in more adverse events and less total RBV dose than PEG-IFN and RBV for 48 weeks, it was able to achieve higher SVR within shorter duration by carefully monitoring adverse events and modifying the RBV dose as required. © 2011 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.


Yoshimura N.,Tokyo Yamate Medical Center | Watanabe M.,Tokyo Medical and Dental University | Motoya S.,Sapporo Kosei General Hospital | Tominaga K.,Dokkyo Medical University | And 4 more authors.
Gastroenterology | Year: 2015

Background & Aims AJM300 is an orally active small-molecule antagonist of the α4 integrin subunit. We performed a randomized trial to investigate the efficacy and safety of AJM300 in patients with active ulcerative colitis (UC). Methods In a double-blind, placebo-controlled, phase 2a study, 102 patients with moderately active UC (Mayo Clinic scores of 6-10, endoscopic subscores ≤2, and rectal bleeding subscores ≤1) who had inadequate response or intolerance to mesalamine or corticosteroids were randomly assigned to receive AJM300 (960 mg) or placebo 3 times daily for 8 weeks. The primary end point was a clinical response at week 8, defined as a decrease in Mayo Clinic score of at least 3 points and a decrease of at least 30% from baseline, with a decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1. Results Clinical response rates were 62.7% and 25.5% at week 8 in the AJM300 group and placebo group, respectively (odds ratio [OR] = 5.35; 95% confidence interval [CI]: 2.23-12.82; P =.0002). Rates of clinical remission (Mayo Clinic score ≤2 and no subscore >1) were 23.5% and 3.9% in the AJM300 group and placebo groups, respectively (OR = 7.81; 95% CI: 1.64-37.24; P =.0099), and rates of mucosal healing (endoscopic subscores of 0 or 1) were 58.8% and 29.4% (OR = 4.65; 95% CI: 1.81-11.90; P =.0014). No serious adverse event, including progressive multifocal leukoencephalopathy, was observed, although more investigations are needed to confirm the safety profile of this drug. Conclusions AJM300 was well tolerated and more effective than placebo in inducing clinical response, clinical remission, and mucosal healing in patients with moderately active UC. ClinicalTrials.jp no: JapicCTI-132293. © 2015 AGA Institute.


Chayama K.,Hiroshima University | Takahashi S.,Hiroshima University | Toyota J.,Sapporo Kosei General Hospital | Karino Y.,Sapporo Kosei General Hospital | And 6 more authors.
Hepatology | Year: 2012

Patients with chronic hepatitis C virus (HCV) infection and previous null response to pegylated interferon (Peg-IFN) and ribavirin (RBV) have limited therapeutic options. HCV genotype 1 is the most common worldwide and the most difficult to treat; genotype 1b is the most common subtype of genotype 1 outside North America. The enhanced antiviral activity achieved by combining two direct-acting antiviral (DAA) agents may improve clinical outcomes. This open-label, phase IIa study included 10 patients with chronic HCV genotype 1b infection and previous null response (<2 log 10 reduction in HCV RNA after 12 weeks) to Peg-IFN and RBV. Patients received dual DAA treatment for 24 weeks with the nonstructural protein 5A replication complex inhibitor, daclatasvir (60 mg once-daily), and the nonstructural protein 3 protease inhibitor, asunaprevir (initially 600 mg twice-daily, then subsequently reduced to 200 mg twice-daily). The primary efficacy endpoint was the proportion of patients with sustained virologic response (SVR) at 12 weeks post-treatment (SVR 12). Nine patients completed 24 weeks of treatment; 1 patient discontinued treatment after 2 weeks. In the 9 patients who completed the full course of treatment, HCV RNA was undetectable at week 8 and remained undetectable through the end of treatment; all 9 patients achieved SVR 12 and SVR 24. HCV RNA also remained undetectable post-treatment in the patient who discontinued after 2 weeks. There was no viral breakthrough. Diarrhea and headache, generally mild, were the most common adverse events; transaminase elevations were reported in 3 patients, but did not result in discontinuation. Conclusions: Dual therapy with daclatasvir and asunaprevir, without Peg-IFN and RBV, can achieve high SVR rates in difficult-to-treat patients with HCV genotype 1b infection and previous null response to Peg-IFN and RBV. (HEPATOLOGY 2011) © 2011 American Association for the Study of Liver Diseases.


Hayashi N.,Kansai Rosai Hospital | Okanoue T.,Saiseikai Suita Hospital | Tsubouchi H.,Kagoshima University | Toyota J.,Sapporo Kosei General Hospital | And 2 more authors.
Journal of Viral Hepatitis | Year: 2012

The aims of this phase III study were to assess the efficacy and safety of telaprevir in combination with peginterferon alfa-2b (PEG-IFN) and ribavirin (RBV) for difficult-to-treat patients who had not achieved sustained virological response (SVR) to prior regimens in Japan. The subjects were 109 relapsers (median age of 57.0 years) and 32 nonresponders (median age of 57.5 years) with hepatitis C virus genotype 1. Patients received telaprevir (750 mg every 8 h) for 12 weeks and PEG-IFN/RBV for 24 weeks. The SVR rates for relapsers and nonresponders were 88.1% (96/109) and 34.4% (11/32), respectively. Specified dose modifications of RBV that differed from that for the standard of care were introduced to alleviate anaemia. RBV dose reductions were used for 139 of the 141 patients. The SVR rates for relapsers did not depend on RBV dose reduction for 20-100% of the planned dose (SVR rates 87.5-100%, P < 0.05). Skin disorders were observed in 82.3% (116/141). Most of the skin disorders were controllable by anti-histamine and/or steroid ointments. The ratios of discontinuation of telaprevir only or of all the study drugs because of adverse events were 21.3% (30/141) and 16.3% (23/141), respectively. A frequent adverse event leading to discontinuation was anaemia. Telaprevir in combination with PEG-IFN/RBV led to a high SVR rate for relapsers and may offer a potential new therapy for nonresponders even with a shorter treatment period. © 2011 Blackwell Publishing Ltd.


Karino Y.,Sapporo Kosei General Hospital | Toyota J.,Sapporo Kosei General Hospital | Ikeda K.,Toranomon Hospital | Suzuki F.,Toranomon Hospital | And 8 more authors.
Journal of Hepatology | Year: 2013

Background & Aims: Daclatasvir and asunaprevir are NS5A and NS3 protease-targeted antivirals currently under development for treatment of chronic hepatitis C virus infection. Clinical data on baseline and on-treatment correlates of drug resistance and response to these agents are currently limited. Methods: Hepatitis C virus genotype 1b Japanese patients (prior null responders to PegIFN-α/RBV [n = 21] or PegIFN-α/RBV ineligible or intolerant [n = 22]) were administered daclatasvir/asunaprevir for 24 weeks during a phase 2a open-label study. Genotypic and phenotypic analyses of NS3 and NS5A substitutions were performed at baseline, after virologic failure, and post-treatment through follow-up week 36. Results: There were three viral breakthroughs and four relapsers. Baseline NS3 polymorphisms (T54S, Q80L, V170M) at amino acid positions previously associated with low-level resistance (<9-fold) to select NS3 protease inhibitors were detected in four null responders and three ineligibles, but were not associated with virologic failure. Baseline NS5A polymorphisms (L28M, L31M, Y93H) associated with daclatasvir resistance (<25-fold) were detected in five null responders and six ineligibles. All three viral breakthroughs and 2/4 relapsers carried a baseline NS5A-Y93H polymorphism. NS3 and NS5A resistance-associated variants were detected together (NS3-D168A/V, NS5A-L31M/V-Y93H) after virologic failure. Generally, daclatasvir-resistant substitutions persisted through 48 weeks post-treatment, whereas asunaprevir-resistant substitutions were no longer detectable. Overall, 5/10 patients with baseline NS5A-Y93H experienced virologic failure, while 5/10 achieved a sustained virologic response. Conclusions: The potential association of a pre-existing NS5A-Y93H polymorphism with virologic failure on daclatasvir/asunaprevir combination treatment will be examined in larger studies. The persistence of treatment-emergent daclatasvir- and asunaprevir-resistant substitutions will require assessment in longer-term follow-up studies. © 2012 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.


Suzuki Y.,Toranomon Hospital | Ikeda K.,Toranomon Hospital | Suzuki F.,Toranomon Hospital | Toyota J.,Sapporo Kosei General Hospital | And 10 more authors.
Journal of Hepatology | Year: 2013

Background & Aims Improved therapeutic options for chronic hepatitis C virus (HCV) infection are needed for patients who are poor candidates for treatment with current regimens due to anticipated intolerability or low likelihood of response. Methods In this open-label, phase 2a study of Japanese patients with chronic HCV genotype 1b infection, 21 null responders (<2 log10 HCV RNA reduction after 12 weeks of peginterferon/ribavirin) and 22 patients intolerant to or medically ineligible for peginterferon/ ribavirin therapy received dual oral treatment for 24 weeks with the NS5A replication complex inhibitor daclatasvir (DCV) and the NS3 protease inhibitor asunaprevir (ASV). The primary efficacy end point was sustained virologic response at 12 weeks post-treatment (SVR12). Results Thirty-six of 43 enrolled patients completed 24 weeks of therapy. Serum HCV RNA levels declined rapidly, becoming undetectable in all patients on therapy by week 8. Overall, 76.7% of patients achieved SVR12 and SVR24, including 90.5% of null responders and 63.6% of ineligible/intolerant patients. There were no virologic failures among null responders. Three ineligible/intolerant patients experienced viral breakthrough and four relapsed post-treatment. Diarrhea, nasopharyngitis, headache, and ALT/AST increases, generally mild, were the most common adverse events; three discontinuations before week 24 were due to adverse events that included hyperbilirubinemia and transaminase elevations (two patients). Conclusions Dual therapy with daclatasvir and asunaprevir, without peginterferon/ribavirin, was well tolerated and achieved high SVR rates in two groups of difficult-to-treat patients with hepatitis C virus genotype 1b infection. © 2012 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.


Sato S.,Sapporo Kosei General Hospital
Rinsho byori. The Japanese journal of clinical pathology | Year: 2010

AFP-L3 is an isoform of a-fetoprotein which has a fucosylated carbohydrate chain, and the fraction of AFP-L3/total AFP (AFP-L3%) specifically increases in hepatocellular carcinoma (HCC) patients and is widely used for screening and prognosis of HCC. The newly developed microTAS method which combines microchip electrophoresis and lectin affinity electrophoresis can rapidly provide AFP-L3% and total AFP measurements simultaneously at higher sensitivity. Here, we evaluated the system to know its analytical performance and clinical utility. Fully automated immunoanalyzer, microTASWako i30 which utilizes Liquid-phase Binding Assay-Electrokinetic Analyte Transport Assay (LBA-EATA method) as the assay principle was employed for the measurement of total AFP and AFP-L3%. We evaluated detection sensitivity, precision, accuracy, and correlation of the method. The detection sensitivity was 0.3 ng/ml for both AFP-L1 and L3. The accuracy of the assay was 91.3-105.0% for total AFP. The precision of the assay was CV 1.9% at 2 ng/ml of total AFP, and CV 1.3% for 10% of AFP-L3% at 20ng/ml of total AFP. The microTAS method showed good correlation with the lectin affinity electrophoresis (AFP-L3 Test Wako) and the LBA methods (LBA Wako AFP-L3 on LiBASys) methods, giving correlation coefficient (r) of 0.988 and 0.988, respectively. The microTAS immunoreaction assay time and the total assay time including chip preparation were 1 and 9 min, respectively. Since the microchip assay is rapid and highly sensitive, it should have better clinical utility than the current methods.


Sato T.,Sapporo Kosei General Hospital | Yamazaki K.,Sapporo Kosei General Hospital
Diagnostic and Therapeutic Endoscopy | Year: 2012

Esophagogastric varices are considered to be the most common complication in patients with portal hypertension. Endoscopic ultrasonography not only visualizes the surface of the varices but also provides detailed information about their internal structure. The direction of blood flow can be determined and its velocity measured only via endoscopic color Doppler ultrasonography (ECDUS). This can show graphically esophageal varices, paraesophageal veins, and passageways in esophageal variceal patients and gastric varices, perigastric collateral veins in gastric variceal patients. It is important to evaluate the hemodynamics of the portal venous system when treating the esophago-gastric varices. ECDUS is a useful modality for the evaluation of the detailed hemodynamics and the therapeutic effects of esophago-gastric varices. © 2012 Takahiro Sato and Katsu Yamazaki.


Sato T.,Sapporo Kosei General Hospital | Yamazaki K.,Sapporo Kosei General Hospital | Akaike J.,Sapporo Kosei General Hospital
Digestive Endoscopy | Year: 2012

Aim: The aim of the present study was to evaluate the clinicopathological features and the efficacy of endoscopic treatments in treating gastric antral vascular ectasia (GAVE) in association with liver diseases. Methods: Thirty-four patients with the characteristic endoscopic findings of GAVE were enrolled. Endoscopic treatments were carried out for all 34 patients, including argon plasma coagulation (APC) in 22 patients and endoscopic band ligation (EBL) in 12 patients. Results: All 34 patients had iron-deficiency anemia and 21 patients also had a history of tarry stools. The underlying pathologies of chronic liver diseases were liver cirrhosis in 26 patients, liver cirrhosis associated with hepatocellular carcinoma in six, and idiopathic portal hypertension in two. The liver function was classified by Child-Pugh classification: class A (n = 6), class B (n = 21), and class C (n = 7). Antral motility was frequent and intense in all 34 GAVE patients. In the 22 patients who received APC, endoscopies revealed the recurrence of GAVE in 15 patients requiring further treatment by APC (recurrence rate, 68.2%). Seven patients died during the follow-up period, including two cases with bleeding-related deaths. In the 12 patients who received EBL, endoscopies revealed the recurrence of GAVE in one patient requiring further treatment by EBL (recurrence rate, 8.3%). Two patients died during the follow-up period, neither were bleeding-related deaths. Conclusions: The results suggest that GAVE is related to severe liver damage and portal hypertension. APC has a high recurrence rate of GAVE in the medium term after treatment. EBL may be useful as a treatment for GAVE. © 2011 Japan Gastroenterological Endoscopy Society.

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