Hiroaki Miyata

Tokyo Healthcare University, Edo, Tōkyō, Japan

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Publications (127)557.33 Total impact

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    ABSTRACT: Background: We investigate rates of pathological complete response (pCR) and tumor expression of ER, PgR, HER2 discordance after neoadjuvant chemotherapy using Japanese breast cancer registry data. Method: Records of more than 300,000 breast cancer cases treated at 800 hospitals from 2004 to 2013 were retrieved from the breast cancer registry. After data cleanup, we included 21,755 patients who received neoadjuvant chemotherapy and had no distant metastases. pCR was defined as no invasive tumor in the breast detected during surgery after neoadjuvant chemotherapy. HER2 overexpression was determined immunohistochemically and/or using fluorescence in situ hybridization. Results: pCR was achieved in 5.7% of luminal tumors (N=8,730), 24.6% of HER2-positive tumors (N=4,403), and 18.9% of triple-negative tumors (N=3,660). Among HER2-positive tumors, pCR was achieved in 31.6% of ER-negative tumors (N=2,252), 17.0% of ER-positive ones (N=2,132), 31.4% of patients who received trastuzumab as neoadjuvant chemotherapy (N=2,437), and 16.2% of patients who did not receive trastuzumab (N=1,966). Of the 2,811 patients who were HER2-positive before treatment, 601 (21.4%) had HER2-negative tumors after neoadjuvant chemotherapy, whereas 340 (3.4%) of the 9,947 patients with HER2-negative tumors before treatment had HER2-positive tumors afterward. Of the 10,973 patients with ER-positive tumors before treatment, 499 (4.6%) had ER-negative tumors after neoadjuvant chemotherapy, whereas 519 (9.3%) of the 5,607 patients who were ER-negative before treatment had ER-positive tumors afterward. Conclusion: We confirmed that loss of HER2-positive status can occur after neoadjuvant treatment in patients with primary HER2-positive breast cancer. We also confirmed that in practice, differences in pCR rates between breast cancer subtypes are the same as in clinical trials. Our data strongly support the need for retest ER, PgR, HER2 of surgical sample after neoadjuvant therapy in order to accurately determine appropriate use of targeted therapy.
    No preview · Article · Dec 2015 · Annals of Oncology
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    ABSTRACT: International collaboration is important in healthcare quality evaluation; however, few international comparisons of general surgery outcomes have been accomplished. Furthermore, predictive model application for risk stratification has not been internationally evaluated. The National Clinical Database (NCD) in Japan was developed in collaboration with the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP), with a goal of creating a standardized surgery database for quality improvement. The study aimed to compare the consistency and impact of risk factors of 3 major gastroenterological surgical procedures in Japan and the United States (US) using web-based prospective data entry systems: right hemicolectomy (RH), low anterior resection (LAR), and pancreaticoduodenectomy (PD).Data from NCD and ACS-NSQIP, collected over 2 years, were examined. Logistic regression models were used for predicting 30-day mortality for both countries. Models were exchanged and evaluated to determine whether the models built for one population were accurate for the other population.We obtained data for 113,980 patients; 50,501 (Japan: 34,638; US: 15,863), 42,770 (Japan: 35,445; US: 7325), and 20,709 (Japan: 15,527; US: 5182) underwent RH, LAR, and, PD, respectively. Thirty-day mortality rates for RH were 0.76% (Japan) and 1.88% (US); rates for LAR were 0.43% versus 1.08%; and rates for PD were 1.35% versus 2.57%. Patient background, comorbidities, and practice style were different between Japan and the US. In the models, the odds ratio for each variable was similar between NCD and ACS-NSQIP. Local risk models could predict mortality using local data, but could not accurately predict mortality using data from other countries.We demonstrated the feasibility and efficacy of the international collaborative research between Japan and the US, but found that local risk models remain essential for quality improvement.
    No preview · Article · Dec 2015 · Medicine

  • No preview · Article · Nov 2015 · JAMA Internal Medicine
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    ABSTRACT: Objective: Using data from the Japan Adult Cardiovascular Surgery Database, we evaluated the prognostic influence of off-pump technique in patients with low ejection fraction who underwent coronary artery bypass grafting. Methods: We analyzed 2187 patients with an ejection fraction <0.30 who underwent primary, nonemergency, isolated coronary artery bypass grafting between 2008 and 2012, as reported in the Japan Adult Cardiovascular Surgery Database. Patients were divided into on-pump (n = 1134; 51.1%) and off-pump (n = 1053; 48.9%) coronary artery bypass grafting groups. Propensity-score matching for 20 preoperative variables was performed, and early mortality and morbidity were compared between matched groups. Results: Propensity-score matching created 918 pairs. Of the 918 patients in the off-pump group, conversion to an on-pump procedure occurred in 56 (6.1%). Compared with on-pump, off-pump technique was associated with significantly lower incidences of 30-day death (1.7% vs 3.7%; P = .01), operative death (3.3% vs 6.1%; P = .006), mediastinitis (1.9% vs 3.4%; P = .041), reoperation for bleeding (0.9% vs 3.5%; P < .001), and prolonged ventilation (8.2% vs 13.4%; P < .001). Comparison of patients undergoing off-pump versus on-pump procedures demonstrated no significant differences in the incidence of stroke (1.5% vs 2.1%; P = .38), renal failure (6.1% vs 7.4%; P = .26), and postoperative dialysis (3.1% vs 4.4%; P = .14). Institutional volume-adjusted analysis confirmed most of these results. Conclusions: Off-pump coronary artery bypass grafting is associated with significantly reduced early mortality and morbidity in patients with an ejection fraction <0.30.
    No preview · Article · Nov 2015 · The Journal of thoracic and cardiovascular surgery
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    ABSTRACT: Background: The authors evaluated the effect of preoperative β-blocker use on early outcomes in patients undergoing coronary artery bypass grafting (CABG) in Japan. Methods: The authors analyzed 34,980 cases of isolated CABGs, performed between 2008 and 2011, at the 333 sites recorded in the Japanese Cardiovascular Surgical Database. In addition to the use of multivariate models, a one-to-one matched analysis, based on estimated propensity scores for patients with or without preoperative β-blocker use, was performed. Results: The study population (mean age, 68 yr) comprised 20% women, and β-blockers were used in 10,496 patients (30%), who were more likely to have risk factors and comorbidities than patients in whom β-blockers were not used. In the β-blocker and non-β-blocker groups, the crude in-hospital mortality rate was 1.7 versus 2.5%, whereas the composite complication rate was 9.7 versus 11.6%, respectively. However, after adjustment, preoperative β-blocker use was not a predictor of in-hospital mortality (odds ratio, 1.00; 95% CI, 0.82 to 1.21) or complications (odds ratio, 0.99; 95% CI, 0.91 to 1.08). When the outcomes of the two propensity-matched patient groups were compared, differences were not seen in the 30-day operative mortality (1.6 vs. 1.5%, respectively; P = 0.49) or postoperative complication (9.8 vs. 9.7%; P = 1.00) rates. The main findings were broadly consistent in a subgroup analysis of low-risk and high-risk groups. Conclusion: In this nationwide registry, the use of preoperative β-blockers did not affect short-term mortality or morbidity in patients undergoing CABG.
    No preview · Article · Oct 2015 · Anesthesiology
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    ABSTRACT: Background: Preprocedural dual antiplatelet therapy (DAPT) in percutaneous coronary interventions (PCI) has been shown to improve outcomes; however, the efficacy of the procedure and its complications in Japanese patients remain largely unexplored, so we examined the risks and benefits of DAPT before PCI and its association with in-hospital outcomes.Methods and Results:We analyzed data from patients who had undergone PCI at 12 centers within the metropolitan Tokyo area between September 2008 and September 2013.Our study group comprised 6,528 patients, of whom 2,079 (31.8%) were not administered preprocedural DAPT. Non-use of preprocedural DAPT was associated with death, postprocedural shock, or heart failure (odds ratio [OR]: 1.47, 95% confidence interval [CI]: 1.10-1.96, P=0.009), and postprocedural myocardial infarction (OR: 1.41, 95% CI: 1.18-1.69, P<0.001) after adjusting propensity scores for known predictors of in-hospital complications. Non-use of DAPT was not associated with procedure-related bleeding complications (OR: 0.98, 95% CI: 0.71-1.59, P=0.764). Conclusions: Approximately one-third of the patients who underwent PCI did not receive preprocedural DAPT despite guideline recommendations. Our results indicate that patients undergoing PCI with DAPT have a lower risk of postprocedural cardiac events without any increased bleeding risk. Further studies are needed to implement the use of DAPT in real-world PCI.
    No preview · Article · Oct 2015 · Circulation Journal
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    ABSTRACT: Background Details on Japanese patients undergoing percutaneous coronary intervention (PCI) and how they compare to US patients remain unclear. Furthermore, the application of US risk models has not been evaluated internationally. Methods The JCD-KiCS, a multicenter registry of consecutive PCI patients, was launched in 2008, with variables defined in accordance with the US NCDR. Patient and procedural characteristics from patients enrolled from 2008 to 2010 in the JCD-KiCS database (n = 9,941) and those in the NCDR (n = 732,345) were compared. The primary outcomes of this analysis were the hospital-level all-cause mortality and bleeding complications. The NCDR risk models for these 2 outcomes were evaluated in the Japanese data set; from the expected mortality and bleeding rates, the observed/expected ratios were calculated. Results The Japanese patients were older, with a higher proportion of men, diabetes, and smoking than the US patients. The Japanese patients also had a higher rate of complex lesions (26.1 vs 12.7% for bifurcation and 6.2% vs 3.2% for chronic total occlusions, all P <.001), longer procedure time (29.7 ± 21.5 vs 14.4 ± 11.5 minutes, P <.001), and higher mortality (1.6% vs 0.9%, P <.001) and bleeding rates (2.9% vs 1.8%, P <.001) compared with US patients. The observed/expected ratios for mortality and bleeding were 0.921 and 0.467, respectively, in Japanese patients, and 1.002 and 0.981, respectively, for US patients. Conclusions The characteristics of patients undergoing PCI in clinical practice in Japan and the US differ substantially. The NCDR risk models applied well in Japanese patients for prediction of mortality, but not for bleeding, which tended to underestimate the risk.
    No preview · Article · Oct 2015
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    ABSTRACT: To define the effects of body mass index (BMI) on operative outcomes for both gastroenterological and cardiovascular surgery, using the National Clinical Database (NCD) of the Japanese nationwide web-based database. The subjects of this study were 288,418 patients who underwent typical surgical procedures between January 2011 and December 2012. There were eight gastroenterological procedures, including esophagectomy, distal gastrectomy, total gastrectomy, right hemicolectomy, low anterior resection, hepatectomy of >1 segment excluding the lateral segment, pancreaticoduodenectomy, and surgery for acute diffuse peritonitis (n = 232,199); and five cardiovascular procedures, including aortic valve replacement, total arch replacement (TAR), descending thoracic aorta replacement (descending TAR), and on- or off-pump coronary artery bypass grafting (n = 56,219). The relationships of BMI with operation time and operative mortality for each procedure were investigated, using the NCD. Operation times were longer for patients with a higher BMI. When a BMI cut-off of 30 was used, the operation time for obese patients was significantly longer than that for non-obese patients, for all procedures except esophagectomy (P < 0.01). The mortality rate based on BMI revealed a U-shaped distribution, with both underweight and obese patients having high mortality rates for almost all procedures. This Japanese nationwide study provides solid evidence to reinforce that both obesity and excessively low weight are factors that impact operative outcomes significantly.
    No preview · Article · Aug 2015 · Surgery Today
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    Full-text · Dataset · Jul 2015
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    ABSTRACT: The aim of the study was to evaluate preoperative variables predictive of lethal morbidities in critically ill surgical patients at a national level. There is no report of risk stratification for morbidities associated with mortality in critically ill patients with acute diffuse peritonitis (ADP). We examined data from 16,930 patients operated during 2011 and 2012 in 1546 different hospitals for ADP identified in the National Clinical Database of Japan. We analyzed morbidities significantly associated with operative mortality. Based on 80% of the population, we calculated independent predictors for these morbidities. The risk factors were validated using the remaining 20%. The operative mortality was 14.1%. Morbidity of any grade occurred in 40.2% of patients. Morbidities correlated with mortality, including septic shock, progressive renal insufficiency, prolonged ventilation >48 hours, systemic sepsis, central nervous system (CNS) morbidities, acute renal failure and pneumonia, and surgical site infection (SSI), were selected for risk models. A total of 18 to 29 preoperative variables were selected per morbidity and yielded excellent C-indices for each (septic shock: 0.851; progressive renal insufficiency: 0.878; prolonged ventilation >48 h: 0.849; systemic sepsis: 0.839; CNS morbidities: 0.848; acute renal failure: 0.868; pneumonia: 0.830; and SSI: 0.688). We report the first risk stratification study on lethal morbidities in critically ill patients with ADP using a nationwide surgical database. These risk models will contribute to patient counseling and help predict which patients require more aggressive surgical and novel pharmacological interventions.
    Full-text · Article · Jul 2015 · Medicine
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    ABSTRACT: We devised a percutaneous coronary intervention (PCI) scoring system based on angiographic lesion complexity and assessed its association with in-hospital complications. Although PCI is finding increasing application in patients with coronary artery disease, lesion complexity can lead to in-hospital complications. Data from 3692 PCI patients were scored based on lesion complexity, defined by bifurcation, chronic total occlusion, type C, and left main lesion, along with acute thrombus in the presence of ST-segment elevation myocardial infarction (1 point assigned for each variable). The patients' mean age was 67.5 +/- 10.8 years; 79.8% were male. About half of the patients (50.3%) presented with an acute coronary syndrome, and 2218 (60.1%) underwent PCI for at least one complex lesion. The patients in the higher-risk score groups were older (p < 0.001) and had present or previous heart failure (p = 0.02 and p = 0.01, respectively). Higher-risk score groups had significantly higher in-hospital event rates for death, heart failure, and cardiogenic shock (from 0 to 4 risk score; 1.7%, 4.5%, 6.3%, 7.1%, 40%, p < 0.001); bleeding with a hemoglobin decrease of >3.0 g/dL (3.1%, 11.0%, 13.1%, 10.3%, 28.6%, p < 0.001); and postoperative myocardial infarction (1.5%, 3.1%, 3.8%, 3.8%, 10%, p = 0.004), respectively. The association with adverse outcomes persisted after adjustment for known clinical predictors (odds ratio 1.72, p < 0.001). The complexity score was cumulatively associated with in-hospital mortality and complication rate and could be used for event prediction in PCI patients.
    Full-text · Article · Jun 2015 · PLoS ONE
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    ABSTRACT: The aim of this study was to compare the cases of minimally invasive mitral valve surgery (MICS-mitral) performed using right mini-thoracotomy (RT) with those performed using median sternotomy (MS). Between 2008 and 2012, 6137 patients underwent isolated mitral valve repair at 210 institutions and were registered in the Japan Adult Cardiovascular Surgery Database. We compared 756 who underwent MICS-mitral via RT to 5381 MS patients and performed a one-to-one matched analysis based on the estimated propensity score. The in-hospital mortality was similar between both groups (RT vs. MS: 0.5 vs. 1.1 %). Although the incidence of postoperative stroke, renal failure, and prolonged ventilation was similar, the number of patients with mediastinitis was greater in the MS group (RT vs. MS: 0 vs. 0.7 %, p < 0.01). Reexploration for bleeding was more frequent in the RT group (RT vs. MS: 2.9 vs. 1.4 %, p < 0.01). Mortality and morbidity occurred at a higher rate in low-volume institutions. The propensity analysis showed that the operation-related times were significantly longer in the RT group, while the length of hospital stay was shorter. In a propensity analysis of patients <60 years of age, there was no in-hospital mortality. MICS-mitral via RT was successful without compromising the clinical outcomes. Although the operation time and postoperative bleeding should be improved, an RT approach is safe in appropriately selected patients, especially those <60 years of age or treated in a high-volume center.
    No preview · Article · Jun 2015 · Surgery Today

  • No preview · Article · Jun 2015 · The Lancet
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    ABSTRACT: Little is known about the outcomes and indications of chronic total occlusion percutaneous coronary intervention (CTO-PCI), other than in high-volume centers. We sought to provide a real-world overview of the clinical outcomes and appropriateness of PCI for CTO. The analysis included 4,950 consecutive PCIs for nonacute indications registered in the multicenter Japanese PCI registry in collaboration with the US National Cardiovascular Data Registry (Cath-PCI). Data included demographics, clinical outcomes (procedural success and complication rates), and the indication appropriateness, based on the 2012 appropriate use criteria for revascularization. The overall procedural success and major adverse cardiac event rates of 501 cases with CTO-PCI (10.1%) were 76% and 3.2%, respectively. Based on the criteria, mapping failures occurred in 2,521 procedures; the remaining 2,429 PCIs were successfully mapped. The CTO-PCIs were performed for more appropriate indications than PCIs for lesions without CTO. The rate of inappropriate indications was significantly lower in CTO-PCIs than in non-CTO-PCIs (23.0% vs 31.4%, p = 0.04). Only 17% of CTO-PCIs were directly assigned to CTO-specific scenarios because such scenarios are only intended for "Lone" CTO; the rest of the CTO-PCI cases were secondarily mapped to non-CTO-specific scenarios. In conclusion, as many as 10% of the elective PCIs were performed for CTO lesions in a contemporary multicenter Japanese PCI registry; CTO-PCI was associated with lower procedural success and higher complication rates than non-CTO-PCI. Its indication was relatively appropriate; however, our findings emphasize the need for more rigorous evaluation in terms of the present insufficient CTO-related clinical scenarios. Copyright © 2015 Elsevier Inc. All rights reserved.
    No preview · Article · Jun 2015 · The American journal of cardiology
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    ABSTRACT: The aim of this study was to compare the long-term outcomes and perioperative outcomes of Laparoscopic liver resection (LLR) with those of open liver resection (OLR) for hepatocellular carcinoma (HCC) between well-matched patient groups. HCC patients underwent primary liver resection between 2000 and 2010, were collected from 31 participated institutions in Japan and divided into LLR (n=436) and OLR (n=2969) groups. A one-to-one propensity case-matched analysis was used with covariates of baseline characteristics, including tumor characteristics and surgical procedures of hepatic resections. Long-term and short-term outcomes were compared between the matched two groups. The two groups were well balanced by propensity score matching and 387 patients were matched respectively. There were no significant differences in overall survival and disease-free survival between LLR and OLR. The median blood loss (158 g vs 400 g, p<0.001) was significantly lesser with LLR, and the median postoperative hospital stay (13 days vs 16 days, p<0.001) was significantly shorter for LLR. Complication rate (6.7% vs 13.0%, p=0.003) was significantly lesser in LLR. Compared with OLR, LLR in selected patients with HCC showed similar long-term outcomes, associated with less blood loss, shorter hospital stay, and fewer postoperative complications. This article is protected by copyright. All rights reserved.
    Full-text · Article · Jun 2015 · Journal of Hepato-Biliary-Pancreatic Sciences
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    ABSTRACT: Laparoscopic distal pancreatectomy has been shown to be associated with favorable postoperative outcomes using meta-analysis. However, there have been no randomized controlled studies yet. This study aimed to compare laparoscopic and open distal pancreatectomy using propensity score-matching. We retrospectively collected perioperative data of 2,266 patients who underwent distal pancreatectomy in 69 institutes from 2006-2013 in Japan. Among them, 2,010 patients were enrolled in this study and divided into two groups, laparoscopic distal pancreatectomy and open distal pancreatectomy. Perioperative outcomes were compared between the groups using unmatched and propensity matched analysis. After propensity score-matching, laparoscopic distal pancreatectomy was associated with favorable perioperative outcomes compared with open distal pancreatectomy, including higher rate of preservation of spleen and splenic vessels (P < 0.001); lower rates of intraoperative transfusion (P = 0.020), clinical grade of pancreatic fistula (International Study Group on Pancreatic Fistula grade B and C; P < 0.001), and morbidity (P < 0.001); and shorter hospital stay (P = 0.001), but a longer operative time (P < 0.001). Laparoscopic distal pancreatectomy was associated with more favorable perioperative outcomes than open distal pancreatectomy. © 2015 Japanese Society of Hepato-Biliary-Pancreatic Surgery.
    Full-text · Article · Jun 2015 · Journal of Hepato-Biliary-Pancreatic Sciences
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    Full-text · Dataset · May 2015
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    Full-text · Dataset · May 2015
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    ABSTRACT: Whereas surgical outcomes of congenital heart surgery have improved during the past two decades, there are still measurable postoperative mortalities in this field. This study is aimed at evaluating the current situation of mortality following congenital heart surgery. Data on all registered 28 810 patients in The Japan Congenital Cardiovascular Surgery Database (JCCVSD) between 2008 and 2012 were analysed, except for patients with degenerative cardiomyopathy including dilated, restrictive and hypertrophic cardiomyopathy, and pathologically or histologically malignant cardiac tumours. The number of registered cases increased every year, and reached ∼9000 cases in 2012. The median age at surgery was 0.8 years (range, 0-82). More than half of the patients (54%) who underwent surgery were <1 year old, and 6.0% of all patients were over 18 years old (adults). In this study, all mortalities within 90 days after the operation and mortality at discharge beyond 90 days of hospitalization were defined as '90-day and in-hospital mortality'. The 30-, 90-day and in-hospital mortality rates were 2.3, 3.5 and 4.5%, respectively. The mean and median durations from surgery to death were 61 ± 89 and 28 days (range, 0-717), respectively. Whereas 658 mortalities (51%) occurred within 30 days of surgery, 265 (21%) occurred later than 90 days after surgery. A total of 3630 patients (13%) were hospitalized for more than 90 days after the operation; of those, 3365 patients survived at discharge (93%). Cardiac problems were the most frequent causes of death after the surgery at any point in time, and 7.1 per 1000 patients died at over 30 days after the operation due to solely cardiac. The investigation of JCCVSD revealed that about a half of mortalities occurred later than 30 days; hence 90-day and in-hospital mortality would be a good discriminator that accurately represented the current situation of mortality after congenital heart surgery. Mortalities long after the operation due to post-cardiotomy heart failure without any other lethal complications were still not rare. © The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
    Full-text · Article · Apr 2015 · Interactive Cardiovascular and Thoracic Surgery
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    ABSTRACT: To clarify the surgical outcome and long-term prognosis of laparoscopic liver resection (LLR) compared with conventional open liver resection (OLR) in patients with colorectal liver metastases (CRLM). A one-to-two propensity score matching (PSM) analysis was applied. Covariates (P < 0.2) used for PSM estimation included preoperative levels of CEA and CA19-9; primary tumor differentiation; primary pathological lymph node metastasis; number, size, location, and distribution of CRLM; existence of extrahepatic metastasis; extent of hepatic resection; total bilirubin and prothrombin activity levels; and preoperative chemotherapy. Perioperative data and long-term survival were compared. From 2005 to 2010, 1,331 patients with hepatic resection for CRLM were enrolled. By PSM, 171 LLR and 342 OLR patients showed similar preoperative clinical characteristics. Median estimated blood loss (163 g vs 415 g, P < .001) and median postoperative hospital stay (12 days vs 14 days; P < .001) were significantly reduced in the LLR group. Morbidity and mortality were similar. Five-year rates of recurrence-free, overall, and disease-specific survival did not differ significantly. The R0 resection rate was similar. In selected CRLM patients, LLR is strongly associated with lower blood loss and shorter hospital stay and has equivalent long-term survival comparable with OLR. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.
    Full-text · Article · Apr 2015 · Journal of Hepato-Biliary-Pancreatic Sciences

Publication Stats

826 Citations
557.33 Total Impact Points

Institutions

  • 2012-2015
    • Tokyo Healthcare University
      Edo, Tōkyō, Japan
    • Nagoya University
      • Division of Cardiac Surgery
      Nagoya, Aichi, Japan
  • 2011-2015
    • Keio University
      • • Department of Health Policy and Management
      • • Department of Cardiology
      Edo, Tokyo, Japan
  • 2005-2015
    • The University of Tokyo
      • • Faculty & Graduate School of Medicine
      • • School of Medicine
      • • Department of Health Science and Nursing
      Tōkyō, Japan
  • 2014
    • Kumamoto University
      • Graduate School of Medical Sciences
      Kumamoto, Kumamoto, Japan
    • Kyoto Prefectural University of Medicine
      • Division of Cardiovascular Surgery
      Kioto, Kyōto, Japan
  • 2006
    • Waseda University
      • Graduate School of Human Sciences
      Edo, Tōkyō, Japan