Haga Y.,Institute for Clinical Research |
Haga Y.,Kumamoto University |
Ikejiri K.,Kyushu Medical Center |
Wada Y.,Himeji Medical Center |
And 2 more authors.
Gastric Cancer | Year: 2015
Conclusions: The current study suggests the possibility of surgical audit for postoperative OS in gastric cancer. Further studies including high-volume centers will be necessary to validate this idea.Background: Previous studies for surgical audit have focused on short-term outcomes, such as perioperative mortality. There has been no gold standard how to evaluate quality of care for long-term outcomes in surgical oncology. This preliminary study aims to propose a method for surgical audit targeting long-term outcome following gastrectomy for gastric cancer.Methods: We prospectively investigated a set of variables relating to physiologic conditions, tumor characteristics and operations in patients who underwent gastrectomy for gastric cancer between June 2005 and July 2008 in 18 referral hospitals in Japan. Overall survival (OS) is the endpoint. Cox hazard regression analysis was used to generate a model to predict OS. The calibration and discrimination power of the model were assessed using the Hosmer-Lemeshow (H-L) test and area under the receiver-operating characteristic curve (AUC), respectively. The ratio of observed-to-estimated 5-year OS rates (OE ratio) was defined as a measure of quality.Results: Among 762 patients analyzed, 697 (91 %) completed the 5-year follow-up. The constructed model for OS exhibited a good discrimination power (AUC, 95 % confidence interval 0.89, 0.86–0.91), which was significantly better than that for the UICC stage (0.81, 0.77–0.84). This model also demonstrated a good calibration power (H-L: χ2 = 27.2, df = 8, P = 0.77). The OE ratios among the participating hospitals revealed no significant variation between 0.74 and 1.1. © 2014, The International Gastric Cancer Association and The Japanese Gastric Cancer Association.
Ogura T.,Kanagawa Cardiovascular and Respiratory Center |
Taniguchi H.,Tosei General Hospital |
Azuma A.,Nippon Medical School |
Inoue Y.,Clinical Research Center |
And 12 more authors.
European Respiratory Journal | Year: 2015
A randomised, double-blind, phase II, dose escalation trial was conducted to assess the safety, tolerability and pharmacokinetics of the tyrosine kinase inhibitor nintedanib, alone and when added to ongoing pirfenidone therapy, in Japanese patients with idiopathic pulmonary fibrosis. 50 Japanese patients were randomised to receive nintedanib or placebo in one of three cohorts (nintedanib 50 mg twice daily or 100 mg twice daily for 14 days, or 150 mg twice daily for 28 days). Patients receiving pirfenidone at inclusion were stratified to every nintedanib dose group and placebo. Adverse events were reported in nine out of 17 patients receiving nintedanib alone and 10 out of 21 patients receiving nintedanib added to pirfenidone. All adverse events were mild or moderate in intensity. Gastrointestinal disorders were the most common adverse event. Maximum plasma concentration and area under the curve at steady state for nintedanib and its metabolites tended to be lower when nintedanib was added to pirfenidone. Nintedanib had no effect on the pharmacokinetics of pirfenidone. In conclusion, further study is needed to evaluate the safety and tolerability profile of nintedanib when added to pirfenidone in patients with idiopathic pulmonary fibrosis. There was a trend toward lower exposure of nintedanib when it was added to pirfenidone. Copyright © ERS 2015.
Matsuoka K.,Himeji Medical Center
International Journal of Surgery Case Reports | Year: 2013
INTRODUCTION Solitary pulmonary metastasis from oral malignant melanoma is very rare. PRESENTATION OF CASE We demonstrated a 84-year-old patient with a lung nodule that was diagnosed as malignant melanoma by video-assisted thoracoscopic resection. Because primary pulmonary malignant melanoma was extremely rare, the tumor was thought to be a metastasized from an occult primary lesion. A detailed physical examination revealed a black tumor in the oral cavity, and this was suspected to have been the primary. Resection of the hard palate tumor and dissection of the cervical lymph nodes were performed. The patient was simply followed up without further therapy at his request, and he died one year after surgery due to bleeding from a pleural metastasis of malignant melanoma. DISCUSSION Primary melanoma of the oral cavity is rare, accounts for 0.5% of all oral cancers, and 0.8-1.8% of all melanomas. Because of absence of symptoms in the early stage of the disease and the presence of the tumor in relatively obscure areas of the oral cavity, the diagnosis is unfortunately often delayed. In view of the rarity of primary lung melanoma, when lung tumor was diagnosed as malignant melanoma, detailed physical examination of the entire skin and mucosa including the oral cavity was necessary. CONCLUSION Oral malignant melanoma was very rare, but oral cavity should be examined when the pulmonary nodule was diagnosed as malignant melanoma. © 2013 The Author.
Haga Y.,Kumamoto Medical Center |
Ikejiri K.,Kyushu Medical Center |
Wada Y.,Himeji Medical Center |
Takahashi T.,Higashihirosima Medical Center |
And 5 more authors.
Annals of Surgery | Year: 2011
Objective: This study was undertaken to evaluate a modified form of Estimation of Physiologic Ability and Surgical Stress (E-PASS) for surgical audit comparing with other existing models. Background: Although several scoring systems have been devised for surgical audit, no nation-wide survey has been performed yet. Methods: We modified our previous E-PASS surgical audit system by computing the weights of 41 procedures, using data from 4925 patients who underwent elective digestive surgery, designated it as mE-PASS. Subsequently, a prospective cohort study was conducted in 43 national hospitals in Japan from April 1, 2005, to April 8, 2007. Variables for the E-PASS and American Society of Anesthesiologists (ASA) status-based model were collected for 5272 surgically treated patients. Of the 5272 patients, we also collected data for the Portsmouth modification of Physiologic and Operative Severity Score for the enUmeration of Mortality and morbidity (P-POSSUM) in 3128 patients. The area under the receiver operative characteristic curve (AUC) was used to evaluate discrimination performance to detect in-hospital mortality. The ratio of observed to estimated in-hospital mortality rates (OE ratio) was defined as a measure of quality. Results: The numbers of variables required were 10 for E-PASS, 7 for mE-PASS, 20 for P-POSSUM, and 4 for the ASA status-based model. The AUC (95% confidence interval) values were 0.86 (0.79-0.93) for E-PASS, 0.86 (0.79-0.92) for mE-PASS, 0.81 (0.75-0.88) for P-POSSUM, and 0.73 (0.63-0.83) for the ASA status-based model. The OE ratios for mE-PASS among large-volume hospitals significantly correlated with those for E-PASS (R = 0.93, N = 9, P = 0.00026), P-POSSUM (R = 0.96, N = 6, P = 0.0021), and ASA status-based model (R = 0.83, N = 9, P = 0.0051). Conclusion: Because of its features of easy use, accuracy, and generalizability, mE-PASS is a candidate for a nation-wide survey. © 2010 Lippincott Williams & Wilkins.
Matsuoka K.,Himeji Medical Center |
Misaki N.,Kagawa University |
Sumitomo S.,Red Cross
Annals of Thoracic and Cardiovascular Surgery | Year: 2010
Background: Pneumonectomy is still a high-risk surgical procedure. Postpneumonectomy bronchopleural fistula is an especially severe complication with a high mortality rate. Although several reports have discussed risk factors for early bronchopleural fistula after pneumonectomy, only a few have reported them for late bronchopleural fistula. We reviewed cases of late bronchopleural fistula after pneumonectomy and investigated its risk factors. Methods: Sixty-four patients with nonsmall cell lung cancer underwent pneumonectomy at our institution from June 1999 to December 2004. Among them, 5 who developed bronchopleural fistula were investigated. Results: All of the 5 patients were male; 3 had undergone right pneumonectomy and 2 left pneumonectomy. The period between surgery and the appearance of bronchopleural fistula ranged from 36 to 164 days. We found that the preoperative serum albumin level was significantly lower in the patients with late bronchopleural fistula. Induction therapy, surgical side, age, anemia, arterial blood oxygen, and respiratory function did not affect the occurrence of bronchopleural fistula after pneumonectomy. Conclusions: A preoperative low-serum albumin level, indicative of poor nutritional status, is a risk factor for late bronchopleural fistula after pneumonectomy for nonsmall cell lung cancer. © 2010 The Editorial Committee of Annals of Thoracic and Cardiovascular Surgery. All rights reserved.