Sakai Municipal Hospital

Ōsaka, Japan

Sakai Municipal Hospital

Ōsaka, Japan
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Imamura H.,Sakai Municipal Hospital | Kurokawa Y.,Osaka University | Tsujinaka T.,Osaka National Hospital | Inoue K.,Osaka Medical College | And 4 more authors.
The Lancet Infectious Diseases | Year: 2012

Background: Although evidence for the efficacy of postoperative antimicrobial prophylaxis is scarce, many patients routinely receive such treatment after major surgeries. We aimed to compare the incidence of surgical-site infections with intraoperative antimicrobial prophylaxis alone versus intraoperative plus postoperative administration. Methods: We did a prospective, open-label, phase 3, randomised study at seven hospitals in Japan. Patients with gastric cancer that was potentially curable with a distal gastrectomy were randomly assigned (1:1) to receive either intraoperative antimicrobial prophylaxis alone (cefazolin 1 g before the surgical incision and every 3 h as intraoperative supplements) or extended antimicrobial prophylaxis (intraoperative administration plus cefazolin 1 g once after closure and twice daily for 2 postoperative days). Randomisation was stratified using Pocock and Simon's minimisation method for institution and American Society of Anesthesiologists scores, and Mersenne twister was used for random number generation. The primary endpoint was the incidence of surgical-site infections. We assessed non-inferiority of intraoperative therapy with a margin of 5%. Analysis was by intention-to-treat. During hospital stay, infection-control personnel assessed patients for infection, and the principal surgeons were required to check for surgical-site infections at outpatient clinics until 30 days after surgery. This study is registered with UMIN-CTR, UMIN000000631. Findings: Between June 2, 2005, and Dec 6, 2007, 355 patients were randomly assigned to receive either intraoperative antimicrobial prophylaxis alone (n=176) or extended antimicrobial prophylaxis (n=179). Eight patients (5%, 95% CI 2-9%) had surgical-site infections in the intraoperative group compared with 16 (9%, 5-14) in the extended group. The relative risk of surgical-site infections with intraoperative antimicrobial prophylaxis was 0·51 (0·22-1·16), which revealed statistically significant non-inferiority (p<0·0001). Interpretation: Elimination of postoperative antimicrobial prophylaxis did not increase the incidence of surgical-site infections after a gastrectomy. Therefore, this treatment is not recommended after gastric cancer surgery. Funding: Osaka Gastrointestinal Cancer Chemotherapy Study Group. © 2012 Elsevier Ltd.

Hirao M.,National Hospital Organization | Takiguchi S.,Osaka University | Imamura H.,Sakai Municipal Hospital | Yamamoto K.,Osaka University | And 6 more authors.
Annals of Surgical Oncology | Year: 2013

Purpose: This randomized, controlled trial evaluated the clinical efficacy of Billroth I (BI) and Roux-en-Y (RY) reconstruction at 1 year after distal gastrectomy for gastric cancer. Methods: The primary end point was the amount of body weight lost at 1 postoperative year, and secondary end points included other items related to nutritional status such as serum albumin and lymphocyte count, as well as endoscopic examination findings of the remnant stomach and esophagus. Of the 332 patients enrolled, 163 were assigned to the BI group and 169 were randomized to the RY group. Results: The loss in body weight 1 year after surgery did not differ significantly between the BI and RY groups (9.1 % and 9.7 %, respectively, p = 0.39). There were no significant differences in other aspects of nutritional status between the 2 groups. Endoscopic examination 1 year after gastrectomy showed reflux esophagitis in 26 patients (17 %) in the BI group versus 10 patients (6 %) in the RY group (p = 0.0037), while remnant gastritis was observed in 71 patients (46 %) in the BI group versus 44 patients (28 %) in the RY group (p = 0.0013); differences were significant for both conditions. Multivariable analysis showed that the only reconstruction was the independently associated factor with the incidence of reflux esophagitis. Conclusions: RY reconstruction was not superior to BI in terms of body weight change or other aspects of nutritional status at 1 year after surgery, although RY more effectively prevented reflux esophagitis and remnant gastritis after distal gastrectomy. © 2012 Society of Surgical Oncology.

Fujitani K.,Osaka National Hospital | Tsujinaka T.,Osaka National Hospital | Fujita J.,Toyonaka Municipal Hospital | Miyashiro I.,Japan National Cardiovascular Center Research Institute | And 6 more authors.
British Journal of Surgery | Year: 2012

Background: Perioperative enteral immunonutrition is thought to reduce postoperative morbidity in patients undergoing major gastrointestinal surgery. This study assessed the clinical effects of preoperative enteral immunonutrition in well nourished patients with gastric cancer undergoing total gastrectomy. Methods: Well nourished patients with primary gastric cancer, fit for total gastrectomy, were randomized to either a control group with regular diet, or an immunonutrition group that received regular diet supplemented with 1000 ml/day of immunonutrients for 5 consecutive days before surgery. The primary endpoint was the incidence of surgical-site infection (SSI). Secondary endpoints were rates of infectious complications, overall postoperative morbidity and C-reactive protein (CRP) levels on 3-4 days after surgery. Results: Of 244 randomized patients, 117 were allocated to the control group and 127 received immunonutrition. SSIs occurred in 27 patients in the immunonutrition group and 23 patients in the control group (risk ratio (RR) 1.09, 95 per cent confidence interval 0.66 to 1.78). Infectious complications were observed in 30 patients in the immunonutrition group and 27 in the control group (RR 1.11, 0.59 to 2.08). The overall postoperative morbidity rate was 30.8 and 26.1 per cent respectively (RR 1.18, 0.78 to 1.78). The median CRP value was 11.8 mg/dl in the immunonutrition group and 9.2 mg/dl in the control group (P = 0.113). Conclusion: Five-day preoperative enteral immunonutrition failed to demonstrate any clear advantage in terms of early clinical outcomes or modification of the systemic acute-phase response in well nourished patients with gastric cancer undergoing elective total gastrectomy. Registration number: ID 000000648 (University Hospital Medical Information Network (UMIN) database). Copyright © 2012 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.

Hirao M.,National Hospital Organization | Tsujinaka T.,National Hospital Organization | Imamura H.,Sakai Municipal Hospital | Kurokawa Y.,Osaka University | And 4 more authors.
Gastric Cancer | Year: 2013

Background: Our objective was to assess the risk factors for surgical site infections (SSIs) in gastric surgery using the results of the Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG) 0501 phase 3 trial. Methods: The OGSG 0501 trial was conducted to compare standard prophylactic antibiotic administration versus extended prophylactic antibiotic administration in 355 patients who underwent open distal gastrectomy for gastric cancer. Various risk factors associated with the incidence of SSI following gastrectomy were analyzed from the results of this multi-institutional randomized controlled trial. Results: Among the 355 patients, there were 24 SSIs, for an overall SSI rate of 7 %. Multivariate analysis using eight baseline factors (administration of antibiotics, age, sex, body mass index [BMI], prognostic nutritional index, tumor stage, lymph node dissection, reconstructive method) identified that BMI ≥25 kg/m2 was an independent risk factor for the occurrence of SSI (odds ratio 2.82; 95 % confidence interval [CI] 1.05-7.52; P = 0.049). BMI also showed significant relationships with the volume of blood loss and the operation time (P = 0.001 and P < 0.001, respectively). Conclusion: Compared with patients of normal weight, overweight patients had a significantly higher risk of SSI after distal gastrectomy for cancer. © 2012 The International Gastric Cancer Association and The Japanese Gastric Cancer Association.

Tsuburaya A.,Yokohama City University | Yoshida K.,Gifu University | Yoshino S.,Yamaguchi University | Takahashi M.,Yokohama Municipal Citizens Hospital | And 14 more authors.
The Lancet Oncology | Year: 2014

Background: The prognosis for locally advanced gastric cancer is poor despite advances in adjuvant chemotherapy. We did the Stomach cancer Adjuvant Multi-Institutional group Trial (SAMIT) to assess the superiority of sequential treatment (paclitaxel then tegafur and uracil [UFT] or paclitaxel then S-1) compared with monotherapy (UFT or S-1) and also the non-inferiority of UFT compared with S-1. Methods: We did this randomised phase 3 trial with a two-by-two factorial design at 230 hospitals in Japan. We enrolled patients aged 20-80 years with T4a or T4b gastric cancer, who had had D2 dissection and a ECOG performance score of 0-1. Patients were randomly assigned to one of four treatment groups with minimisation for tumour size, lymph node metastasis, and study site. Patients received UFT only (267 mg/m2 per day), S-1 only (80 mg/m2 per day) for 14 days, with a 7-day rest period or three courses of intermittent weekly paclitaxel (80 mg/m2) followed by either UFT, or S-1. Treatment lasted 48 weeks in monotherapy groups and 49 weeks in the sequential treatment groups. The primary endpoint was disease-free survival assessed by intention to treat. We assessed whether UFT was non-inferior to S-1 with a non-inferiority margin of 1·33. This trial was registered at UMIN Clinical Trials Registry, number C000000082. Findings: We randomly assigned 1495 patients between Aug 3, 2004, and Sept 29, 2009. 374 patients were assigned to receive UFT alone, 374 to receive S-1 alone, 374 to received paclitaxel then UFT, and 373 to receive paclitaxel then S-1. We included 1433 patients in the primary analysis after at least 3 years of follow-up (359, 364, 355, and 355 in each group respectively). Protocol treatment was completed by 215 (60%) patients in the UFT group, 224 (62%) in the S-1 group, 242 (68%) in the paclitaxel then UFT group, and 250 (70%) in the paclitaxel then S-1 group. 3-year disease-free survival for monotherapy was 54·0% (95% CI 50·2-57·6) and that of sequential treatment was 57·2% (53·4-60·8; hazard ratio [HR] 0·92, 95% CI 0·80-1·07, p=0·273). 3-year disease-free survival for the UFT group was 53·0% (95% CI 49·2-56·6) and that of the S-1 group was 58·2% (54·4-61·8; HR 0·81, 95% CI 0·70-0·93, p=0·0048; pnon-inferiority=0·151). The most common grade 3-4 haematological adverse event was neutropenia (41 [11%] of 359 patients in the UFT group, 48 [13%] of 363 in the S-1 group, 46 [13%] of 355 in the paclitaxel then UFT group, and 83 [23%] of 356 in the paclitaxel then S-1 group). The most common grade 3-4 non-haematological adverse event was anorexia (21 [6%], 24 [7%], seven [2%], and 18 [5%], respectively). Interpretation: Sequential treatment did not improve disease-free survival, and UFT was not non-inferior to S-1 (and S-1 was superior to UFT), therefore S-1 monotherapy should remain the standard treatment for locally advanced gastric cancer in Japan. Funding: Epidemiological and Clinical Research Information Network. © 2014 Elsevier Ltd.

Masuda N.,National Hospital Organization | Sagara Y.,Sagara Hospital | Kinoshita T.,National Cancer Center Hospital | Iwata H.,Aichi Cancer Center Hospital | And 7 more authors.
The Lancet Oncology | Year: 2012

Background: Aromatase inhibitors have shown increased efficacy compared with tamoxifen in postmenopausal early breast cancer. We aimed to assess the efficacy and safety of anastrozole versus tamoxifen in premenopausal women receiving goserelin for early breast cancer in the neoadjuvant setting. Methods: In this phase 3, randomised, double-blind, parallel-group, multicentre study, we enrolled premenopausal women with oestrogen receptor (ER)-positive, HER2-negative, operable breast cancer with WHO performance status of 2 or lower. Patients were randomly assigned (1:1) to receive goserelin 3·6 mg/month plus either anastrozole 1 mg per day and tamoxifen placebo or tamoxifen 20 mg per day and anastrozole placebo for 24 weeks before surgery. Patients were randomised sequentially, stratified by centre, with randomisation codes. All study personnel were masked to study treatment. The primary endpoint was best overall tumour response (complete response or partial response), assessed by callipers, during the 24-week neoadjuvant treatment period for the intention-to-treat population. The primary endpoint was analysed for non-inferiority (with non-inferiority defined as the lower limit of the 95% CI for the difference in overall response rates between groups being 10% or less); in the event of non-inferiority, we assessed the superiority of the anastrozole group versus the tamoxifen group. We included all patients who received study medication at least once in the safety analysis set. We report the primary analysis; treatment will also continue in the adjuvant setting for 5 years. This trial is registered with ., number . NCT00605267. Findings: Between Oct 2, 2007, and May 29, 2009, 204 patients were enrolled. 197 patients were randomly assigned to anastrozole (n=98) or tamoxifen (n=99), and 185 patients completed the 24-week neoadjuvant treatment period and had breast surgery (95 in the anastrazole group, 90 in the tamoxifen group). More patients in the anastrozole group had a complete or partial response than did those in the tamoxifen group during 24 weeks of neoadjuvant treatment (anastrozole 70·4% [69 of 98 patients] . vs tamoxifen 50·5% [50 of 99 patients]; estimated difference between groups 19·9%, 95% CI 6·5-33·3; p=0·004). Two patients in the anastrozole group had treatment-related grade 3 adverse events (arthralgia and syncope) and so did one patient in the tamoxifen group (depression). One serious adverse event was reported in the anastrozole group (benign neoplasm, not related to treatment), compared with none in the tamoxifen group. Interpretation: Given its favourable risk-benefit profile, the combination of anastrozole plus goserelin could represent an alternative neoadjuvant treatment option for premenopausal women with early-stage breast cancer. Funding: AstraZeneca. © 2012 Elsevier Ltd.

Terashima M.,Shizuoka Cancer Center | Kitada K.,National Cancer Center Hospital East | Ochiai A.,National Cancer Center Hospital East | Ichikawa W.,National Defense Medical College | And 6 more authors.
Clinical Cancer Research | Year: 2012

Purpose: EGF receptor (EGFR) and HER2 positivity are considered to be negative prognostic factors in gastric cancer. Biomarker analysis was conducted to evaluate the impact of EGFR and HER2 expression on the outcome of patients enrolled in the Adjuvant Chemotherapy Trial of TS-1 for Gastric Cancer (ACTS-GC), a randomized controlled trial comparing postoperative adjuvant S-1 therapy with surgery alone in 1,059 patients with stage II/III gastric cancer. Experimental Design: Formalin-fixed, paraffin-embedded surgical specimens were retrospectively examined in 829 patients (78.3%). The effects of EGFR and HER2 positivity on survival were analyzed on the basis of the 5-year survival data from the study. EGFR positivity was defined as an immunohistochemistry (IHC) score of 3+, and HER2 positivity as an IHC score of 3+ or an IHC score of 2+ with a positive dual-color in situ hybridization status. Results: EGFR and HER2 were positive in 75 (9.0%) and 113 (13.6%) patients, respectively. The overall and relapse-free survival rates were significantly lower in EGFR-positive patients than in EGFR-negative patients, whereas they were similar in HER2-positive and HER2-negative patients. Multivariate analysis showed that EGFR positivity correlated with poor outcomes [HR = 1.504; 95% confidence interval (CI) = 1.020-2.149; P = 0.040]. Treatment with S-1 improved survival compared with surgery alone, irrespective of EGFR and HER2 status. Conclusions: EGFR positivity, but not HER2 positivity, was associated with poor patient outcomes after curative resection of stage II/III gastric cancer. There was no interaction between S-1 and EGFR or HER2 status with respect to survival outcome. ©2012 AACR.

Ikeda H.,Sakai Municipal Hospital
Japanese Journal of Clinical Radiology | Year: 2012

This issue describes current status and prospects of physics/technology aspects of quality assurance in radiotherapy in Japan. With the advent of several radiotherapy accidents in Japan around 2001-04, radiotherapy QA/QC system was totally reviewed. After all, in 2004 a Working Group composed of executives from 5 societies related to radiological practices (later named as Japanese Organization for Radiotherapy Quality Management) issued a proposal for radiotherapy institutions (1) to settle radiotherapy quality assurance committee in each institution, (2) to nurture certified radiotherapy quality manager, and (3) to conduct third-party auditing. The Japanese Government approved designated hospitals for cancer control since 2000, and number of designated hospitals increased from 266 in 2005 to 372 in 2009. However the structure of radiotherapy institutions has not substantially been improved in terms of installations and staffs, which has not kept up with the natural increase of number of patients, even in designated hospitals. Under these circumstances QA activities has to be conducted. Now, with respect to third-party QA activities, Association of Nuclear Technology in Medicine conducts several activities, namely, standardized calibration of dosimeter and postal dosimetry system using glass-rod dosimeter.

Matsushita A.,Sakai Municipal Hospital
Gan to kagaku ryoho. Cancer & chemotherapy | Year: 2013

Bisphosphonates have been used clinically as highly effective drugs in the treatment of hypercalcemia of malignancy, and bone metastasis of solid cancers. Despite these benefits, however, the emergence of bisphosphonate-related osteonecrosis of the jaws has become a growing and significant problem in a subset of patients receiving these drugs. We report a rare case of brain abscess secondary to BRONJ in metastatic bone lesions from breast carcinoma.

Oda K.,Sakai Municipal Hospital
Kyobu geka. The Japanese journal of thoracic surgery | Year: 2011

A 69-year-old man with right aortic arch was diagnosed as having left lung cancer (cT2aN1M0, cStage IIA) and an aneurysm of an aberrant left subclavian artery. The aneurysm measured 36 mm in diameter and was located 1 cm peripheral from the origin in the area known as "Kommerell's diverticulu Left carotid artery-to-left subclavian artery bypass graft was placed through a left supraclavicular incision prior to thoracotomy. This bypass graft effectively prevented neurological and ischemic complications of the brain and left upper extremity while we safely and successfully performed resection of the aneurysm along with radical surgery for left lung cancer through left thoracotomy. There have been only 10 case reports, including the present case, that have described surgical resection of lung cancer in a patient with right aortic arch. In addition, this is the 1st report to describe simultaneous surgery for both left lung cancer and an aneurysm of an aberrant left subclavian artery in a patient with right aortic arch.

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