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Kuriyama A.,Kurashiki Central Hospital | Honda M.,Cancer Institute Ariake Hospital | Hayashino Y.,Tenri Hospital
Sleep Medicine | Year: 2014

Ramelteon is the first selective melatonin receptor agonist and currently is approved in the United States and Japan for the treatment of insomnia. Our meta-analysis assessed the efficacy and safety of ramelteon for the treatment of insomnia in adults. We included both published and unpublished data from randomized placebo-controlled trials evaluating the efficacy of ramelteon in adults with insomnia in the analysis. Our primary outcomes were sleep quality, subjective sleep latency (sSL), and subjective total sleep time (sTST). Secondary outcomes included latency to persistent sleep (LPS), total sleep time (TST), sleep efficiency (SE), proportion of rapid eye movement (REM) sleep, wakefulness after sleep onset (WASO), subjective WASO, number of nighttime awakenings (NAW), subjective NAW, and adverse events.Thirteen trials involving 5812 patients with insomnia or insomnia symptoms with a mean study duration of 38. days were pooled. Ramelteon was associated with reduced sSL (weighted mean difference [WMD], -4.30. min [95% confidence interval {CI}, -7.01 to -1.58]) and improved sleep quality (standardized mean differences, -0.074 [95% CI, -0.13 to -0.02]) but was not associated with increased sTST. Ramelteon also was associated with improvement in LPS, SE, and TST. The only significant adverse event was somnolence. Short-term use of ramelteon was associated with improvement in some sleep parameters in patients with insomnia, but its clinical impact is small. Long-term trials are needed before solid conclusions can be established. © 2014 Elsevier B.V.


Hida K.,Kyoto University | Hida K.,Nishi Kobe Medical Center | Hasegawa S.,Kyoto University | Kinjo Y.,Kyoto University | And 8 more authors.
Annals of Surgery | Year: 2012

Objective: To investigate the hypothesis that laparoscopic primary tumor resection is safe and effective when compared with the open approach for colorectal cancer patients with incurable metastases. Background: There are only a few reports with small numbers of patients on laparoscopic tumor resection for stage IV colorectal cancer. Methods: Data from consecutive patients who underwent palliative primary tumor resection for stage IV colorectal cancer between January 2006 and December 2007 were collected retrospectively from 41 institutions. Short-and long-term outcomes were compared between patients who underwent laparoscopic or open resection. Results: A total of 904 patients (laparoscopic group: 226, open group: 678) with a median age of 64 years (range: 22-95) were included in the analysis. Conversion was required in 28 patients (12.4%) and the most common reasons for conversion (23/28: 82%) were bulky or invasive tumors. There was no 30-day postoperative mortality in either group. The complication rate (NCI-CTCAE grade 2-4) after laparoscopic surgery (17%) was significantly lower than that after open surgery (24%) (P = 0.02), and the difference was greater (4% vs 12%; P < 0.001) when we limited the analysis to severe (grade 3) complications. The median length of postoperative hospital stay in the laparoscopic group was significantly shorter than that in the open group (14 vs 17 days; P = 0.002). In univariate analysis, overall survival for the laparoscopic group was significantly better than that for open surgery (median survival time: 25.9 vs 22.3 months, P = 0.04), although no difference was apparent in multivariate analysis. Conclusions: Compared with open surgery, laparoscopic primary tumor resection has advantages in the short term and no disadvantages in the long term. It is a reasonable treatment option for certain stage IV colorectal cancer patients with incurable disease. © 2012 by Lippincott Williams & Wilkins.


Nunobe S.,Cancer Institute Ariake Hospital | Hiki N.,Cancer Institute Ariake Hospital | Gotoda T.,National Center for Global Health and Medicine | Murao T.,Kawasaki Medical School | And 6 more authors.
Gastric Cancer | Year: 2012

In the current era of endoscopic submucosal dissection (ESD) for early gastric cancer, which carries a negligible risk of lymph node metastasis, local resection of the stomach remains an option for these lesions. This is particularly so for a large intramucosal lesion or a lesion with a strong ulcer scar, for which ESD becomes a difficult option. Here, we describe a case of lateral-spreading intramucosal gastric cancer of 6-cm diameter located at the fornix of the stomach, which was successfully treated by laparoscopic and endoscopic cooperative surgery (LECS) because of the expected risk of complications during ESD. In the LECS procedure, the resection margin was appropriately determined by the endoscopic evaluation in detail and by the ESD technique. If early gastric cancer fits the criteria for endoscopic resection but would present difficulty if performing ESD, this is a good indication for the LECS procedure. © 2011 The International Gastric Cancer Association and The Japanese Gastric Cancer Association.


Kurokawa Y.,Osaka National Hospital | Sasako M.,Hyogo College of Medicine | Sano T.,Cancer Institute Ariake Hospital | Shibata T.,Clinical Data | And 4 more authors.
British Journal of Surgery | Year: 2011

Background: Extended gastrectomy with para-aortic nodal dissection (PAND) or thorough dissection of mediastinal nodes using a left thoracoabdominal (LTA) approach is an alternative to D2 lymphadenectomy, with variable postoperative results. Methods: Two randomized controlled trials have been conducted to compare D2 lymphadenectomy alone (263 patients) versus D2 lymphadenectomy plus PAND (260), and the abdominal-transhiatal (TH) approach (82) versus the LTA approach (85), in patients with gastric cancer. Prospectively registered secondary endpoints bodyweight, symptom scores and respiratory function were evaluated in the present study. Results: Bodyweight was comparable after D2 and D2 plus PAND, but higher after TH than after LTA procedures at 1 and 3 years. At 1- and 3-year follow-up symptom scores were comparable between D2 and D2 plus PAND. A LTA approach resulted in significantly worse scores than a TH approach in terms of meal volume, return to work, incisional pain and dyspnoea up to 1 year. The decrease in vital capacity was significantly greater after LTA than TH procedures up to 6 months. Conclusion: Bodyweight and postoperative symptoms were not affected by adding PAND to a D2 procedure. A LTA approach aggravated weight loss, symptoms and respiratory functions compared with a TH approach. Registration numbers: NCT00149279, NCT00149266 (). Copyright © 2010 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.


Nakajima T.,Cancer Institute Ariake Hospital | Nakajima T.,Japan Cancer Clinical Research Organization JACCRO | Fujii M.,Surugadai University
World Journal of Gastroenterology | Year: 2014

After a long history of Dark Age of adjuvant chemotherapy for gastric cancer, definite evidences of survival benefit from adjuvant treatment have been reported since 2000s. These survival benefits are likely attributed to something new approach different from pervious studies. In 2001, South West Oncology Group INT0116 trial yielded survival benefit in curatively resected gastric cancer patients with postoperative chemoradiotherapy [5-fluorouracil (5-FU) + Leucovorin + radiotherapy], followed by positive result by MAGIC Trial, employing perioperative( pre- and postoperative chemotherapy with Epirubicin, cisplatin (CDDP), 5-fluorouracil (ECF) regimen in patients with curative resection. A novel drug [S1: ACTS-GC (Adjuvant chemotherapy trial of TS-1 for gastric cancer) in 2007], or new drug combination chemotherapys [CDDP + 5-FU: FNCLCC/FFCD (Federation Nationale des Centres de Lutte contre le cancer/Federation Francophone de Cancerologie Digestive) in 2011, Capecitabine + Oxaliplatin: CLASSIC in 2012] also produced positive results in terms of improved prognosis. Neoadjuvant or perioperative chemotherapy, novel anticancer drugs, and chemoradiotherapy might be the key words to develop further improvement in the adjuvant treatment of resectable gastric cancer. Moreover, it is not new but still true to stress the importance of D2 surgery as the baseline treatment in order to minimize the amount of residual tumor after surgery. © 2014 Baishideng Publishing Group Inc. All rights reserved.


Nunobe S.,Cancer Institute Ariake Hospital | Hiki N.,Cancer Institute Ariake Hospital | Hiki N.,Cancer Institute Hospital | Tanimura S.,Cancer Institute Ariake Hospital | And 4 more authors.
Journal of Gastrointestinal Surgery | Year: 2011

Background: Esophagojejunostomy during laparoscopic total gastrectomy (LATG) using a circular stapler is a difficult procedure for which there remains no widely accepted standard technique. Based upon our experience with esophagogastrostomy during laparoscopic proximal gastrectomy, we have applied a modified lift-up method to LATG. Material and methods: Esophagojejunostomy using a modified lift-up method was performed during LATG in 41 patients with early gastric cancer, from July 2005 to June 2010. The lift-up technique comprises three steps, which together reduce the difficulty of anvil insertion by lifting up the nasogastric tube connected to the anvil head. Results: During the early stages of the present study, some patients who underwent LATG with the modified lift-up method developed anastomotic leakage, with stenosis occurring in two cases (4. 9%) and three cases (7. 3%), respectively. All patients who developed complications showed improvement following conservative treatment with no surgical procedure. The anastomotic leaks occurred during the later periods of the study. There was no mortality in the present study. Conclusions: Our modified lift-up technique facilitates circular-stapled esophagojejunostomy in LATG and could provide a more feasible and safe option for an established procedure, especially for preventing anastomotic leak. © 2011 The Society for Surgery of the Alimentary Tract.


Kinoshita T.,National Cancer Center Hospital East | Kinoshita T.,Aichi Cancer Center Hospital | Saiura A.,Cancer Institute Ariake Hospital | Esaki M.,National Cancer Center Hospital | And 2 more authors.
British Journal of Surgery | Year: 2014

Background The efficacy of surgical resection for gastric cancer liver metastases (GCLMs) is currently debated. Hitherto, no large-scale clinical studies have been conducted. Justified in selected patientsMethods This retrospective multicentre study analysed a database of consecutive patients with either synchronous or metachronous metastases who underwent surgical R0 resection for GCLM between 1990 and 2010. Clinical data were collected from five cancer centres in Japan. Survival curves were assessed, and clinical parameters were evaluated to identify predictors of prognosis.Results A total of 256 patients were enrolled. The mean(s.d.) number of hepatic tumours resected was 2·0(2·4). The surgical mortality rate was 1·6 per cent. Median follow-up was 65 (range 1-261) months. Recurrences were detected in 192 patients (75·0 per cent). The median interval from hepatic resection to recurrence was 7 (range 1-72) months, and the dominant site of recurrence was the liver (72·4 per cent). Actuarial 1-, 3- and 5-year overall and recurrence-free survival rates were 77·3, 41·9 and 31·1 per cent, and 43·6, 32·4 and 30·1 per cent, respectively. Median overall and recurrence-free survival times were 31·1 and 9·4 months respectively. Multivariable analysis identified serosal invasion of the primary gastric cancer (hazard ratio (HR) 1·50; P = 0·012), three or more liver metastases (HR 2·33; P < 0·001) and liver tumour diameter at least 5 cm (HR 1·62; P = 0·005) as independent predictors of poor survival.Conclusion Clinically resectable GCLM is rare, but strict and careful patient selection can lead to long-term survival following R0 surgical resection. © 2014 BJS Society Ltd. Published by John Wiley & Sons Ltd.


Takemura N.,Cancer Institute Ariake Hospital | Saiura A.,Cancer Institute Ariake Hospital | Koga R.,Cancer Institute Ariake Hospital | Arita J.,Cancer Institute Ariake Hospital | And 7 more authors.
Langenbeck's Archives of Surgery | Year: 2012

Purpose: The indication for hepatectomy in cases of gastric cancer liver metastases (GLM) remains unclear and it remains controversial whether surgical resection is beneficial for GLM. The objective of this retrospective study was to clarify the indications for and benefit of hepatectomy for GLM. Methods: Seventy-three patients underwent hepatectomies for GLM from January 1993 to January 2011. Macroscopically complete (R0 or R1) resection was achieved in 64 patients. Among them, 32 patients underwent synchronous hepatectomy with gastrectomy and the remaining 32 patients underwent metachronous hepatectomy. Repeat hepatectomy was done in 14 patients for resectable intrahepatic recurrences. Clinicopathological factors were evaluated by univariate and multivariate analyses among patients who received macroscopically complete resection for those affecting survival. Results: The overall 1-, 3-, and 5-year survival rates after macroscopically complete (R0 or R1) liver resection (n∈=∈64) for GLM were 84, 50, and 37 %, respectively, with a median survival of 34 months. Univariate analysis identified serosal invasion of the primary gastric cancer and blood transfusions during surgery as poor prognosis indicators. By multivariate analysis, serosal invasion of the primary gastric cancer and larger hepatic tumor (>5 cm in diameter) were found to be independent indicators of poor prognosis. Conclusions: GLM patients with the maximum diameter of hepatic tumors of <5 cm and without serosal invasion of the primary gastric cancer are the best candidate for hepatectomy. © 2012 Springer-Verlag.


Hiki N.,Cancer Institute Ariake Hospital | Nunobe S.,Cancer Institute Ariake Hospital | Kubota T.,Cancer Institute Ariake Hospital | Jiang X.,Cancer Institute Ariake Hospital
Annals of Surgical Oncology | Year: 2013

The number of early gastric cancer (EGC) cases has been increasing because of improved diagnostic procedures. Applications of function-preserving gastric cancer surgery may therefore also be increasing because of its low incidence of lymph node metastasis, excellent survival rates, and the possibility of less-invasive procedures such as laparoscopic gastrectomy being used in combination. Pylorus-preserving gastrectomy (PPG) with radical lymph node dissection is one such function-preserving procedure that has been applied for EGC, with the indications, limitations, and survival benefits of PPG already reported in several retrospective studies. Laparoscopy-assisted proximal gastrectomy has also been applied for EGC of the upper third of the stomach, although this procedure can be associated with the 2 major problems of reflux esophagitis and carcinoma arising in the gastric stump. In the patient with EGC in the upper third of the stomach, laparoscopy-assisted subtotal gastrectomy with a preserved very small stomach may provide a better quality of life for the patients and fewer postoperative complications. Finally, the laparoscopy endoscopy cooperative surgery procedure combines endoscopic submucosal dissection with laparoscopic gastric wall resection, which prevents excessive resection and deformation of the stomach after surgery and was recently applied for EGC cases without possibility of lymph node metastasis. Function-preserving laparoscopic gastrectomy is recommended for the treatment of EGC if the indication followed by accurate diagnosis is strictly confirmed. Preservation of remnant stomach sometimes causes severe postoperative dysfunctions such as delayed gastric retention in PPG, esophageal reflux in PG, and gastric stump carcinoma in the remnant stomach. Moreover, these techniques present technical difficulties to the surgeon. Although many retrospective studies showed the functional benefit or oncological safety of function-preserving gastrectomy, further prospective studies using large case series are necessary. © 2013 Society of Surgical Oncology.


Akiyoshi T.,Cancer Institute Ariake Hospital | Fujimoto Y.,Cancer Institute Ariake Hospital | Konishi T.,Cancer Institute Ariake Hospital | Kuroyanagi H.,Cancer Institute Ariake Hospital | And 3 more authors.
World Journal of Surgery | Year: 2010

Background: Loop ileostomy is customary after very low rectal anastomosis to reduce the rate of pelvic sepsis that can result from anastomotic leakage. To evaluate complications of stoma closure is important to maximize the benefit of making the defunctioning stoma. The aim of this study was to examine possible risk factors associated with complications, especially wound infections, after loop ileostomy closure in patients with rectal tumor. Methods: Data from 125 consecutive patients who underwent an elective closure of loop ileostomy after primary rectal tumor resection from January 2005 and October 2009 at a single institution were prospectively collected. Nineteen independent clinical variables were examined by univariate and multivariate analyses. Results: Postoperative complications developed in 21 (16.8%) patients, including 20 (16%) wound infections, 1 (0.8%) ileus, and 1 (0.8%) anastomotic bleeding. There was no postoperative mortality. Risk factors for wound infection included male gender (odds ratio = 5.30; 95% confidence interval 1.14-24.8; p = 0.0339) and surgical site infection (SSI) after primary surgery (odds ratio = 5.00; 95% confidence interval 1.24-20.1; p = 0.0234). Mean length of postoperative hospital stay was significantly longer in patients with complications than in patients without them (14.0 versus 11.0 days; p = 0.0078). Conclusions: The present study showed that most complications associated with ileostomy closure in a homogeneous group of patients with rectal tumor were wound infections. Male gender and SSI after primary surgery were independent risk factors for the development of wound infections. Surgeons should be aware of such high-risk patients, and techniques other than primary closure might need to be considered in high-risk patients to reduce wound infections. © 2010 Société Internationale de Chirurgie.

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