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Tsujinaka T.,Kaizuka City Hospital | Yamamoto K.,National Hospital Organisation Osaka National Hospital | Fujita J.,Nippon Telegraph and Telephone | Endo S.,Higashiosaka City General Hospital | And 7 more authors.
The Lancet | Year: 2013

Background Staples have been widely used for skin closure after open gastrointestinal surgery. The potential advantages of subcuticular sutures compared with staples have not been assessed. We assessed the differences in the frequency of wound complications, including superficial incisional surgical site infection and hypertrophic scar formation, depending on whether subcuticular sutures or staples are used. Methods We did a multicentre, open-label, randomised controlled trial at 24 institutions between June 1, 2009, and Feb 28, 2012. Eligible patients aged 20 years or older, with adequate organ function and undergoing elective open upper or lower gastrointestinal surgery, were randomly assigned preoperatively to either staples or subcuticular sutures for skin closure. Randomisation was done via a computer-generated permuted-block sequence, and was stratified by institution, sex, and type of surgery (ie, upper or lower gastrointestinal surgery). Our primary endpoint was the incidence of wound complications within 30 days of surgery. Analysis was done by intention to treat. This study is registered with UMINCTR, UMIN000002480. Findings 1080 patients were enrolled and randomly assigned in a one to one ratio: 562 to subcuticular sutures and 518 to staples. 1072 were eligible for the primary endpoint and 1058 for the secondary endpoint. Of the 558 patients who received subcuticular sutures, 382 underwent upper gastrointestinal surgery and 176 underwent lower gastrointestinal surgery. Wound complications occurred in 47 of 558 patients (8·4%, 95% CI 6·3-11·0). Of the 514 who received staples, 413 underwent upper gastrointestinal surgery and 101 underwent lower gastrointestinal surgery. Wound complications occurred in 59 of 514 (11·5%, 95% CI 8·9-14·6). Overall, the rate of wound complications did not differ significantly between the subcuticular sutures and staples groups (odds ratio 0·709, 95% CI 0·474-1·062; p=0·12). Interpretation The efficacy of subcuticular sutures was not validated as an improvement over a standard procedure for skin closure to reduce the incidence of wound complications after open gastrointestinal surgery.


Kurokawa Y.,Osaka University | Sugimoto N.,Japan National Cardiovascular Center Research Institute | Miwa H.,Hyogo College of Medicine | Tsuda M.,Hyogo Cancer Center | And 10 more authors.
British Journal of Cancer | Year: 2014

Background: S-1, an oral fluoropyrimidine, plus cisplatin (SP) is a standard regimen for advanced gastric cancer (AGC) in East Asia. To date, no studies have evaluated the efficacy and safety of trastuzumab combined with SP in patients with human epidermal growth factor receptor type 2 (HER2)-positive AGC. Methods: Patients with HER2-positive AGC received S-1 (80-120 mg per day) orally on days 1-14, cisplatin (60 mg m-2) intravenously on day 1, and trastuzumab (course 1, 8 mg kg-1; course 2 onward, 6 mg kg -1) intravenously on day 1 of a 21-day cycle. The primary end point was response rate (RR); secondary end points included overall survival (OS), progression-free survival (PFS), time to treatment failure (TTF), and adverse events. Results: A total of 56 patients were enrolled. In the full analysis set of 53 patients, the confirmed RR was 68% (95% confidence interval (CI)=54-80%), and the disease control rate was 94% (95% CI=84-99%). Median OS, PFS, and TTF were estimated as 16.0, 7.8, and 5.7 months, respectively. Major grade 3 or 4 adverse events included neutropaenia (36%), anorexia (23%), and anaemia (15%). Conclusions: Trastuzumab in combination with SP showed promising antitumour activity and manageable toxic effects in patients with HER2-positive AGC. © 2014 Cancer Research UK.


Nagamoto Y.,Osaka University | Ishii T.,Kaizuka City Hospital | Sakaura H.,Osaka University | Iwasaki M.,Osaka University | And 5 more authors.
Spine | Year: 2011

Study Design.: Kinematics of the cervical spine during head rotation was investigated using 3-dimensional (3D) magnetic resonance imaging (MRI) in patients with cervical spondylosis (CS). Objective.: To demonstrate in vivo 3D kinematics of the spondylotic cervical spine during head rotation. Summary OF Background Data.: Several in vivo studies have identified kinematic differences between normal and spondylotic subjects, but only two-dimensional flexion/extension motion has been investigated. Differences of in vivo 3D cervical motion during head rotation between normal and spondylotic subjects have yet to be clarified. Methods.: Ten healthy volunteers (control group) and 15 patients with CS (CS group) underwent 3D MRI of the cervical spine with the head rotated to 5 positions (neutral, ±45° and ±maximal head rotation). Relative motions of the cervical spine were calculated by automatically superimposing a segmented 3D MRI of the vertebra in the neutral position over images for each position using volume registration. The 3D motions of adjacent vertebra were represented with 6 degrees of freedom by Euler angles and translations on the coordinate system. Results.: Compared with the control group, the CS group showed significantly decreased mean axial rotation and mean coupled lateral bending at C5-C6 and C6-C7 and significantly increased mean coupled lateral bending at C2-C3 and C3-C4, although both the groups showed the same pattern of coupled motions. Conclusion.: The in vivo 3D kinematics of the spondylotic cervical spine during head rotation was accurately depicted and compared with those of healthy cervical spines for the first time. Copyright © 2011 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.


Hirota M.,Kumamoto Regional Medical Center | Ogawa M.,Kaizuka City Hospital
Journal of the Pancreas | Year: 2014

Background Pancreatectomy is the only effective treatment for cancers of the pancreas. Surgeons usually grasp tumors during pancreatectomy, however, this procedure may increase the risk of squeezing and shedding of the cancer cells into the portal vein, retroperitoneum, and/or peritoneal cavity. In an effort to overcome these problems, we have developed surgical techniques for no-touch pancreatectomy. Methods From April 2008 through September 2013, 52 patients have been operated on no-touch pancreatectomy for invasive ductal carcinoma of the pancreas by a single operator (M.H.). Among them, 40 received pancreatoduodenectomy (PD), and 12 did distal pancreatectomy (DP). Twenty two cases (42%) required SMV-PV resection. This is a study to see if pancreatectomy can be technically done using a no-touch surgical technique without deteriorating the post-operative prognosis. During the procedure, the pancreatic tumor is neither grasped nor squeezed by the surgeon. Furthermore, for improved dissection of the retroperitoneal tissue (leftward and posterior margins for PD and rightward and posterior margins for DP), we use a hanging and clamping maneuver and dissection behind Gerota fascia. Results Overall 2- and 5-year survival rates were 64 and 42% with mean follow-up periods of 34.4 months (range: 6-68 months). Recurrence free 2- and 5-year survival rates were 49 and 31%, respectively. The 5-year survival rates of patients with JPS-stage III and those with JPS-stage IV were 57 and 20%, respectively. The 5-year survival rates of patients with UICC-stage IIA and those with UICCstage IIB were 49 and 39%, respectively. Patients with UICC-stage III or IV did not survive for more than 2 years. Conclusions No-touch pancreatectomy has many theoretic advantages that merit further investigation in future randomized controlled trials.


Fujitani K.,Osaka Prefectural General Medical Center | Yang H.-K.,Seoul National University | Mizusawa J.,Clinical Data | Kim Y.-W.,National Cancer Center | And 15 more authors.
The Lancet Oncology | Year: 2016

Background: Chemotherapy is the standard of care for incurable advanced gastric cancer. Whether the addition of gastrectomy to chemotherapy improves survival for patients with advanced gastric cancer with a single non-curable factor remains controversial. We aimed to investigate the superiority of gastrectomy followed by chemotherapy versus chemotherapy alone with respect to overall survival in these patients. Methods: We did an open-label, randomised, phase 3 trial at 44 centres or hospitals in Japan, South Korea, and Singapore. Patients aged 20-75 years with advanced gastric cancer with a single non-curable factor confined to either the liver (H1), peritoneum (P1), or para-aortic lymph nodes (16a1/b2) were randomly assigned (1:1) in each country to chemotherapy alone or gastrectomy followed by chemotherapy by a minimisation method with biased-coin assignment to balance the groups according to institution, clinical nodal status, and non-curable factor. Patients, treating physicians, and individuals who assessed outcomes and analysed data were not masked to treatment assignment. Chemotherapy consisted of oral S-1 80 mg/m2 per day on days 1-21 and cisplatin 60 mg/m2 on day 8 of every 5-week cycle. Gastrectomy was restricted to D1 lymphadenectomy without any resection of metastatic lesions. The primary endpoint was overall survival, analysed by intention to treat. This study is registered with UMIN-CTR, number UMIN000001012. Findings: Between Feb 4, 2008, and Sept 17, 2013, 175 patients were randomly assigned to chemotherapy alone (86 patients) or gastrectomy followed by chemotherapy (89 patients). After the first interim analysis on Sept 14, 2013, the predictive probability of overall survival being significantly higher in the gastrectomy plus chemotherapy group than in the chemotherapy alone group at the final analysis was only 13·2%, so the study was closed on the basis of futility. Overall survival at 2 years for all randomly assigned patients was 31·7% (95% CI 21·7-42·2) for patients assigned to chemotherapy alone compared with 25·1% (16·2-34·9) for those assigned to gastrectomy plus chemotherapy. Median overall survival was 16·6 months (95% CI 13·7-19·8) for patients assigned to chemotherapy alone and 14·3 months (11·8-16·3) for those assigned to gastrectomy plus chemotherapy (hazard ratio 1·09, 95% CI 0·78-1·52; one-sided p=0·70). The incidence of the following grade 3 or 4 chemotherapy-associated adverse events was higher in patients assigned to gastrectomy plus chemotherapy than in those assigned to chemotherapy alone: leucopenia (14 patients [18%] vs two [3%]), anorexia (22 [29%] vs nine [12%]), nausea (11 [15%] vs four [5%]), and hyponatraemia (seven [9%] vs four [5%]). One treatment-related death occurred in a patient assigned to chemotherapy alone (sudden cardiopulmonary arrest of unknown cause during the second cycle of chemotherapy) and one occurred in a patient assigned to chemotherapy plus gastrectomy (rapid growth of peritoneal metastasis after discharge 12 days after surgery). Interpretation: Since gastrectomy followed by chemotherapy did not show any survival benefit compared with chemotherapy alone in advanced gastric cancer with a single non-curable factor, gastrectomy cannot be justified for treatment of patients with these tumours. Funding: The Ministry of Health, Labour and Welfare of Japan and the Korean Gastric Cancer Association. © 2016 Elsevier Ltd.


Yamamoto K.,National Hospital Organization Osaka National Hospital | Tsujinaka T.,Kaizuka City Hospital | Takahashi T.,Osaka University | Sato S.,Shizuoka General Hospital | And 5 more authors.
Annals of Surgical Oncology | Year: 2015

Background: Gastrointestinal stromal tumors (GISTs) of the stomach are found incidentally during gastric cancer screening in Japan. This study investigated whether the Japanese gastric cancer screening system helps to improve treatment outcomes in gastric GIST based on an analysis of the GIST registry conducted by the Kinki GIST Study Group.Methods: The registry was designed to collect data on background characteristics, treatment methods, pathologic characteristics, and prognosis of GIST from January 2003 through December 2007 at 40 participating institutions.Results: The study enrolled 672 GIST patients, 482 of whom had gastric GIST. According to the modified National Institutes of Health consensus criteria, 22.6 % of the patients were classified as high risk for recurrence, 18.5 % as intermediate risk, 35.9 % as low risk, and 13.9 % as very low risk. After exclusion of the patients inevaluable for treatment outcome, the study included 137 symptomatic patients (symptomatic group) and 147 asymptomatic patients (asymptomatic group). The diagnosis of the asymptomatic patients was determined through gastric cancer screening. The median tumor size in the asymptomatic group was significantly smaller than in the symptomatic group (3.5 vs. 5.3 cm; P < 0.0001). The 5-year recurrence-free survival rate in the asymptomatic high-risk patients (72.4 %) was lower than in their symptomatic counterparts (46.3 %) (P = 0.017). More patients in the asymptomatic group underwent laparoscopic surgery (42.2 vs. 27.2 %; P = 0.0081).Conclusions: By identifying asymptomatic patients, the Japanese gastric cancer screening system contributes to early detection of gastric GIST and favorable treatment outcomes. © 2014, Society of Surgical Oncology.


Fujimori T.,Osaka University | Iwasaki M.,Osaka University | Nagamoto Y.,Osaka University | Ishii T.,Kaizuka City Hospital | And 4 more authors.
Journal of Neurosurgery: Spine | Year: 2012

Object. Ossification of the posterior longitudinal ligament (OPLL) is a progressive disease that causes cervical myelopathy. Because 2D evaluation of ossification growth with plain lateral radiographs has limitations, the authors developed a unique technique to measure ossification progression and volume increase by using multidetector CT scanning. Methods. The authors used serial thin-slice volume data obtained by multidetector CT scanning in 5 patients. The mean patient age was 63 years, and the mean follow-up duration was 3.1 years. First, a 3D model of OPLL was semiautomatically segmented at a specific threshold. Then, a preoperative model of OPLL was superimposed on a postoperative model using voxel-based registration of the vertebral bodies. Progression and volume increase were measured using a digital viewer that was developed by the authors. Progression was visualized using a color-coded contour on the surface of the OPLL model. Results. All patients had progression of 0.5 mm or greater. The mean values concerning OPLL growth were as follows: maximum progression length, 4.7 mm; progression rate, 1.5 mm/year; volume increase, 1622 mm 3; volume expansion rate, 37%; and volume increase rate, 484 mm 3/year. The accuracy of superimposition by voxel-based registration, defined as closeness to the true value, was less than 0.31 mm. For intraobserver reproducibility of the volume measurement, the mean intraclass correlation coefficient, root mean square error, and coefficient of variation were 0.987, 16.0 mm3, and 1.7%, respectively. Conclusions. Ossification of the posterior longitudinal ligament progresses even after surgery. Three-dimensional evaluation with the aid of CT scans is a useful and reliable method for assessing that growth.


Tsujinaka T.,Kaizuka City Hospital
Gan to kagaku ryoho. Cancer & chemotherapy | Year: 2016

Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG) was established in 2000 and has been conducting investigator initiated multi-institutional collaboration trials regarding the treatment of gastrointestinal cancer, especially using chemotherapeutic agents. Although organization of OGSG has been renovated to perform post-marketing clinical trials with high quality, OGSG is now facing severe financial crisis because of shortage of donation from pharmaceutical companies. Here, present problems and future perspectives are discussed.


Kohjimoto Y.,Wakayama Medical University | Sasaki Y.,Wakayama Medical University | Iguchi M.,Kaizuka City Hospital | Matsumura N.,Wakayama Medical University | And 2 more authors.
American Journal of Kidney Diseases | Year: 2013

Background: Although metabolic syndrome and its individual components have been associated with kidney stone disease, whether the clustering of metabolic syndrome traits increases the severity of kidney stone disease has not been examined in a large-scale study. Study Design: Cross-sectional analysis. Setting & Participants: Data were obtained from 30,448 patients enrolled in the 6th Nationwide Survey on Urolithiasis in Japan conducted in 2005. Patients with lower urinary tract stones, struvite stones, cystine stones, or hyperparathyroidism and those younger than 15 years were excluded. Predictor: Number of metabolic syndrome traits (obesity [body mass index ≥25 kg/m 2], diabetes, hypertension, and dyslipidemia). Outcomes: Severe form of kidney stone disease, defined as recurrent and/or multiple stones, and abnormalities in urine constituents (hypercalciuria, hyperuricosuria, hyperoxaluria, and hypocitraturia). Results: 11,555 patients were included in the final analyses. Proportions of patients with recurrent and/or multiple stones were 57.7%, 61.7%, 65.2%, 69.3%, and 73.3% with 0, 1, 2, 3, and 4 metabolic syndrome traits, respectively (P < 0.001). There was a significant and stepwise increase in the odds of recurrent and/or multiple stones after adjustment for age and sex. In patients with 4 metabolic syndrome traits, the odds was 1.8-fold greater compared with patients with 0 traits (OR, 1.78; 95% CI, 1.22-2.66). In addition, the presence of metabolic syndrome traits was associated with significantly increased odds of having hypercalciuria, hyperuricosuria, hyperoxaluria, and hypocitraturia after adjustment for age and sex. Limitations: Cross-sectional design, absence of dietary data, ill-defined diagnostic criteria for metabolic syndrome traits, and missing data for the majority of participants. Conclusions: Metabolic syndrome trait clustering is associated with greater severity of kidney stone disease; increased urinary calcium, uric acid, and oxalate excretion; and decreased urinary citrate excretion. These results suggest that kidney stone disease should be regarded as a systemic disorder linked to metabolic syndrome. © 2013 National Kidney Foundation, Inc.


Inoue T.,Kaizuka City Hospital
Gan to kagaku ryoho. Cancer & chemotherapy | Year: 2011

We report two cases of primary advanced breast cancer that was locally controlled by using Mohs'paste. CASE 1: A 70- year-old woman was suffering massive exudates and offensive smell from her right giant breast tumor. Histopathological examination showed an invasive ductal carcinoma. However, she didn't have distant metastases. The patient received chemotherapy and the breast tumor has been fixed using Mohs'paste, and dissected. The giant tumor became flat and dry, so we could perform a radical operation. Then, she had contra-lateral axillary lymph node metastases. We performed a resection of left axillary lymph node and radiation therapy. After two years, we have not found a new lesion. CASE 2: A 54-year- old woman with right local advanced breast cancer discharged massive exudates and oozed blood. Histopathologically, she had an invasive ductal carcinoma. Moreover, she had lung and contra-lateral axillary lymph node metastases. She received chemotherapy and the breast tumor has been fixed using Mohs'paste, and dissected. The bleeding and exudates stopped almost completely, and the breast tumor became flat and dry. Both patients had experienced a mild pain, but their QOL improved remarkably. It is suggested that the patient with local advanced breast cancer may be controlled by using Mohs' paste.

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