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Purpose To assess the increase in hospital costs associated with postoperative complications after lower anterior resection (LAR) for rectal cancer. Methods The subjects of this retrospective analysis were patients who underwent elective LAR surgery between April, 2015 and March, 2017, collected from a Japanese nationwide gastroenterological surgery registry linked to hospital-based claims data. We evaluated total and category-specific hospitalization costs based on the level of postoperative complications categorized using the Clavien–Dindo (CD) classification. We assessed the relative increase in hospital costs, adjusting for preoperative factors and hospital case volume. Results We identified 15,187 patients (mean age 66.8) treated at 884 hospitals. Overall, 71.8% had no recorded complications, whereas 7.6%, 10.8%, 9.0%, 0.6%, and 0.2% had postoperative complications of CD grades I–V, respectively. The median (25th–75th percentiles) hospital costs were $17.3 K (16.1–19.3) for the no-complications group, and $19.1 K (17.3–22.2), $21.0 K (18.5–25.0), $27.4 K (22.4–33.9), $41.8 K (291–618), and $22.7 K (183–421) for the CD grades I–V complication groups, respectively. The multivariable model identified that complications of CD grades I–V were associated with 11%, 21%, 61%, 142%, and 70% increases in in-hospital costs compared with no complications. Conclusions Postoperative complications and their severity are strongly associated with increased hospital costs and health-care resource utilization. Implementing strategies to prevent postoperative complications will improve patients’ clinical outcomes and reduce hospital care costs substantially.

Background It is unclear to what extent a board certification system and implementation of clinical guidelines improves the quality of hepatectomy. Methods A web‐based questionnaire survey was administered to departments registered with the National Clinical Database (NCD) in Japan between 1 October 2014 and 31 January 2015. Quality indicators (QIs), including affiliations with academic societies, numbers of board‐certified doctors affiliated with each institute, and adherence to clinical practice guidelines for hepatocellular carcinoma, were evaluated by calculating risk‐adjusted odds ratios (AORs) for 90‐day postoperative mortality of patients who had undergone hepatectomy in 2013 and 2014. Results Of 1255 departments that had registered at least one hepatectomy in NCD, 592 departments, performing 8601 hepatectomies in total, responded to the questionnaire. AORs were significantly lower in departments that were certified as training hospitals by the Japanese Society of Gastroenterological Society, Japanese Society of Hepato‐Biliary‐Pancreatic Surgery (JSHBPS), and Japan Society of Hepatology than in non‐certified departments. Affiliation of three or more JSHBPS‐certified experts or instructors with an institution also contributed to low AORs. None of the QIs regarding implementation of guidelines significantly impacted on the AOR. Conclusions Quality indicator measurements may improve quality of post‐hepatectomy outcomes in Japan., Highlight Arita and colleagues analyzed the impact of the board certification system and implementation of clinical practice guidelines on 90‐day post‐hepatectomy mortality. Board certification by three academic societies and the number of board‐certified doctors significantly correlated with mortality, while none of the quality indicators regarding implementation of clinical practice guidelines did.

Background and Aim In 2015, the Japanese Society of Gastroenterological Surgery (JSGS) initiated data verification in the gastroenterological section of the National Clinical Database (NCD) and reported high accuracy of data entry. Remote audits were introduced for data validation on a trial basis in 2016 and formally accepted into use in 2017‐2018. The aim of this study was to audit the data quality of the NCD gastroenterological section for 2016‐2018 and to confirm the high accuracy of data in remote audits. Methods Each year, 45‐46 hospitals were selected for audit. Twenty cases were randomly selected in each hospital, and the accuracy of patient demographic and surgical outcome data (46 items) was compared with the corresponding medical records obtained by visiting the hospital (site‐visit audit) or by mailing data from the hospital to the JSGS office (remote audit). Results A total of 136 hospitals were included, of which 88 (64.7%) had a remote audit, and 124 936 items were evaluated with an overall data accuracy of 98.1%. There was no significant difference in terms of data accuracy between site‐visit audit and remote audit. Accuracy, sensitivity, and specificity of mortality were 99.7%, 89.7%, 100% for site‐visit audits and 99.8%, 97.3%, 100% for remote audits, respectively. Mean time spent on data verification per case of remote audits was shorter than that of site‐visit audits (10.0 minutes vs 13.7 minutes, P, The Japanese National Clinical Database (NCD) covers > 95% of the surgical operations carried out in Japan. The aim of this study was to audit the data quality of the NCD gastroenterological section for 2016‐2018. The audits showed that NCD data are reliable and characterized by high accuracy.

This study compared the quality of healthcare before and after implementation of a policy restructuring the healthcare delivery system and estimated the impact of centralization. We used the National Clinical Database to study patients undergoing esophagectomies from 2011 to 2016. We compared the effect of centralization based on the patient background, surgical mortality, and year of surgery. Difference-in-difference methods based on the generalized estimating equation logistic regression model were used for before-and-after comparisons after adjusting for patient-level expected surgical mortality. In total, 34,640 cases were identified. More cases with risk factors were noted in ultra-low-volume hospitals, where 38.4% of cases in underpopulated areas were treated, than in higher volume facilities, and the operative mortality, readmission within 30 days and length of stay were worse among patients treated in these hospitals. In centralized prefectures, the number of cases per hospital increased over time (7.2 in 2011 to 9.5 in 2016) while the crude operative mortality tended to decrease (3.4% in 2011 to 1.8% in 2016). The difference-in-difference estimator was 0.856 (95% confidence interval: 0.639–1.147, p = 0.298). The centralization of ultra-low-volume hospitals did not lead to a deterioration in the quality of care but rather an improving trend.

Objectives To investigate the effect of geriatric variables on five newly added outcomes and create risk models for predicting these outcomes. Summary background data Because there is a current lack of geriatric research focusing on geriatric outcomes using a national surgical database in Japan, there is a need to investigate outcomes associated with major gastroenterological surgery using these data. Methods This multicenter prospective cohort study was conducted at 26 surgery departments across 21 institutions in Japan using the National Clinical Database (NCD) surgical registry. In total, 22 new geriatric variables were imported from the ACS NSQIP geriatric pilot study. The following five geriatric outcomes were defined: 1) postoperative delirium, 2) physical function on postoperative day 30, 3) fall risk on discharge, 4) discharge other than home with social service, and 5) functional decline on discharge, and geriatric risk prediction models for major gastroenterological surgery were created. Results Between January 2018 and December 2018, data on 3,981 procedures from seven major gastroenterological surgeries were collected and analyzed. Older age and preoperative geriatric variables (Origin status from home, History of dementia, Use of mobility aid, Fall history, and Not competent on admission) were strongly associated with postoperative outcomes. Geriatric risk prediction models for these outcomes were created, with C-statistic values ranging from 0.74 to 0.90, demonstrating model validity and sufficiency of fit. Conclusions The risk models for the newly defined five geriatric outcomes that we created can be used in the decision-making process or provision of care in geriatric patients.

Purposes The aim of this study was to clarify the impact of a board certification system and the implementation of clinical practice guidelines for pancreatic cancer (PC) on the mortality of pancreaticoduodenectomy in Japan. Methods By a web questionnaire survey via the National Clinical Database (NCD) for departments participating in the NCD, quality indicators (QIs) related to the treatment for PC, namely the board certification systems of various societies and the adherence to clinical practice guidelines for PC, were investigated between October 2014 and January 2015. A multivariable logistic regression analysis was performed to evaluate the relationship between the QIs and mortality of pancreaticoduodenectomy. Results Of 1415 departments that registered at least 1 pancreaticoduodenectomy between 2013 and 2014 in NCD, 631 departments (44.6%), which performed pancreaticoduodenectomy for a total of 11,684 cases, answered the questionnaire. The mortality of pancreaticoduodenectomy was positively affected by the board certification systems of the Japanese Society of Gastroenterological Surgery, Japanese Society of Hepato-Biliary-Pancreatic Surgery, Japanese Society of Gastroenterology, and Japanese Society of Medical Oncology as well as by institutions that used magnetic resonance imaging of ≥ 3 T for the diagnosis of PC in principle. Conclusions The measurement of the appropriate QIs is suggested to help improve the mortality in pancreaticoduodenectomy. Masamichi Mizuma and Hiroyuki Yamamoto equally contributed

Background: The aim of this study was to investigate the effect of pretransplant culture on the survival of panThe aim of this study was to investigate the effect of pretransplant culture on the survival of pancreatic islet grafts, and to determine the biological characteristics of isolated islets during pretransplant culture. Methods: The survival of islets from Wistar rats, transplanted to diabetic C57BL/B6 mice, was compared between fresh islets and cultured islets. A comprehensive gene expression analysis was employed to investigate biological processes during pretransplant culture, and in vitro validation studies were performed. Results: Survival of cultured xenografts was significantly prolonged as compared to that of fresh islets (fresh:12.5 ± 1.9 days, 1-day cultured:16.0 ± 1.3 days (p= 0.017), 3-day cultured:17.0 ± 2.6 days (p= 0.014)). Comprehensive gene expression analysis identified significant upregulation of annotated functions associated with inflammation in cultured groups. Six proinflammatory genes, including heme oxygenase 1 (HO-1) and IL-6, were significantly upregulated during culture. Validation studies revealed significantly higher levels of IL-6 in the supernatant of cultured islets and HO-1 in the cultured islets when compared with fresh islets. Conclusion: Transplantation of cultured islets induced significant but minimal prolongation of graft survival in xenogeneic combinations. Comprehensive analysis of gene expression in cultured islets showed biological processes associated with proinflammation during culture.

A 82-year-old man presented with diarrhea and fatigue. He had no past medical or surgical history except chronic renal failure. Locally advanced rectal cancer with invasion to left ureter was detected in computed tomography. Colonoscopy revealed a circular lesion 12 cm from the anal verge. Biopsy showed moderately differentiated adenocarcinoma. There was no sign of distal metastasis and we decided to conduct radical surgery. Robot-assisted laparoscopic lower anterior resection with partial resection of left ureter, and diverting ileostomy were carried out. Besides, urinary tract reconstruction of ureterocystoneostomy using Lich-Gregoir technique was conducted by urologists also with robot assistance. The pathological stage of the disease was pT4b(left ureter)N1bM0, pStage Ⅲc. The resection margin was secured and radical surgery was achieved. The patient was discharged on postoperative day 22nd without postoperative complication. He is alive without recurrence at 6 months after the operation.

In Japan, the standard treatment for squamous cell anal cancer(SCAC)has not been established. Herein, we report a case of SCAC that completely responded to chemoradiotherapy(CRT).A woman in her 80s presented with anal pain and bleeding. Computed tomography revealed bilateral inguinal adenopathy and a tumor in the anal canal. Histopathological examination of endoscopic biopsies showed adenocarcinoma. Thus, she was diagnosed with anal canal adenocarcinoma and lymph node metastases:cT3, cN1a(No. 292), cM0, cStage Ⅲc(Japanese Classification of Colorectal, Appendiceal, and Anal Carcinoma, 9th edition). Owing to her advanced age and refusal of a stoma, CRT(S-1, mitomycin C, and radiotherapy)was administered with the expectation that salvage surgery in the form of rectal amputation would eventually be necessary. The tumor noticeably shrank after CRT. The patient is alive to this date,14 months after the final round of CRT.

Aim Gastric cancer is the second leading cause of cancer death worldwide. Surgery is the mainstay treatment for gastric cancer. There are no prediction models that examine the severity of postoperative morbidity. Herein, we constructed prediction models that analyze the risk for postoperative morbidity based on severity. Methods Perioperative data were retrieved from the National Clinical Database in patients who underwent elective gastric cancer resection between 2011 and 2012 in Japan. Severity of postoperative complications was determined by Clavien‐Dindo classification. Patients were randomly divided into two groups, the development set and the validation set. Logistic regression analysis was used to build prediction models. Calibration powers of the models were assessed by a calibration plot in which linearity between the observed and predicted event rates in 10 risk bands was assessed by the Pearson R 2 statistic. Results We obtained 154 278 patients for the analysis. Prediction models were constructed for grade ≥2, grade ≥3, grade ≥4, and grade 5 in the development set (n = 77 423). Calibration plots of these models showed significant linearity in the validation set (n = 76 855): R 2 = 0.995 for grade ≥2, R 2 = 0.997 for grade ≥3, R 2 = 0.998 for grade ≥4, and R 2 = 0.997 for grade 5 (all: P

Aim To investigate the frequency and risk factors of perioperative, symptomatic venous thromboembolism (VTE) after gastroenterological surgery. Methods We assessed the frequency of and risk factors for VTE after eight gastroenterological procedures (total 516 217 cases including, gastrectomy, total gastrectomy, hepatectomy, esophagectomy, right hemicolectomy, low anterior resection, pancreaticoduodenectomy, and acute pan‐peritonitis surgery) based on data from the National Clinical Database. Data collected between 2011 and 2013 (382 124 cases) were used as a test set, and data from 2014 (134 093 cases) were used as a validation set. Results The frequency of deep vein thrombosis (DVT) was 0.3% (382 124 cases), and the incidence of pulmonary embolism (PE) was 0.2% (382 124 cases) ranging from 0.1% to 0.7% for DVT and from 0.1% and 0.3% for PE among eight surgeries, respectively. Analyses using pre‐and intra‐operative factors identified the top three risk factors for VTE as esophagectomy, pancreaticoduodenectomy, and hepatectomy. Using pre‐, intra‐, and postoperative factors, the second through fourth risk factors were sepsis, prolonged ventilation >48 hours and readmission within 30 days. The highest risks factor for PE using pre‐, intra‐, and postoperative factors were any cardiac events. Unplanned intubation was the fourth risk factor. Conclusion The risk for DVT and PE differed for each surgical procedure. VTE and PE risk factors changed after considering postoperative factors. It may be necessary to reconsider the prophylaxis depending on whether the complication occurs after surgery, particularly breathing and cardiac complications.

Background The Japanese National Clinical Database (NCD) is a large‐scale, nationwide, web‐based data entry system that is linked to the surgical board certification system and covers almost all surgical cases carried out in Japan. Aim To evaluate outcomes according to the gastroenterological section of the NCD. Methods The 115 surgical procedures stipulated by the “Training Curriculum for Board‐Certified Surgeons in Gastroenterology” were registered from 2011 to 2017. The number of surgeries, preoperative comorbidities, and short‐term outcomes were compared between registration periods. Results In total, 3 818 414 cases have been registered. More than 70% of all surgeries were carried out at certified institutions. The annual number of cases has been increasing year after year, and the aged population has also been increasing. Although the rates of preoperative comorbidities and postoperative complications have been increasing, the postoperative mortality rate has remained relatively low; in 2017, the 30‐day mortality rate was 1.0% among those who underwent esophagectomy, 0.7% among those who underwent distal gastrectomy, 1.1% among those who underwent total gastrectomy, 1.3% among those who underwent right hemicolectomy, 0.5% among those who underwent low anterior resection, 1.3% among those who underwent hepatectomy, and 1.3% among those who underwent pancreaticoduodenectomy. The annual rate of endoscopic surgery dramatically increased over 7 years between 2011 and 2017, especially for low anterior resection (29.5%‐62.6%) and esophagectomy (31.0%‐56.1%). Conclusion This database is expected to ensure the quality of the board‐certification system and surgical outcomes in gastroenterological surgery.

Background The aim of the present study was to develop a risk calculator predictive of postoperative pneumonia in patients undergoing gastroenterological surgery. Methods We analyzed data from 382 124 patients undergoing eight main gastroenterological surgeries between 2011 and 2013 using the National Clinical Database in Japan. A risk model was developed using multivariate logistic regression analysis with patient data from 2011 to 2012 (n = 247 604) and validated using data from 2013 (n = 134 520). Results Pneumonia was observed in 11 105 patients (2.9%). After the input of significant primary disease and surgical procedures, 18 patient characteristics including gender, chronic obstructive pulmonary disease, sepsis, and need for any assistance in the activities of daily living, six laboratory parameters, and two intraoperative factors were used for risk calculation. Area under the receiver‐operating characteristic curve was 0.822 (95% confidence interval, 0.817‐0.826) in the derivation group and 0.826 (0.819‐0.832) in the validation group. Conclusion The risk calculator accurately predicted the occurrence of pneumonia following gastroenterological surgery.

Background It remains unknown how much institutional medical structure and process of implementation of clinical practice guidelines for esophageal cancers can improve quality of surgical outcome in Japan. Methods A web-based questionnaire survey was performed for departments registered in the National Clinical Database in Japan from October 2014 to January 2015. Quality indicators (QIs) including structure and process indicators (clinical practice guideline adherence) were evaluated on the risk-adjusted odds ratio for operative mortality (AOR) of the patients using registered cases in the database who underwent esophagectomy and reconstruction in 2013 and 2014. Results Among 916 departments which registered at least one esophagectomy case during the study period, 454 departments (49.6%) responded to the questionnaire. Analyses of 6661 cases revealed that two structure QIs (certification of training hospitals by Japan Esophageal Society and presence of board-certified esophageal surgeons) were associated with significantly lower AOR (p

Background Genetically modified pigs (GMP) have been developed to alleviate the shortage of donors in human islet transplantation and rejection. In this study, we characterized and compared the islets from GalTKO, GalTKO/hCD46, GalTKO/hCD46/hCD39, and wild-type (WT) neonatal pigs. Methods Islets were isolated from GMP and WT pig pancreases that have been packaged with ice pack for at least 24 hours. The difference in gene expression and function of islets were evaluated by microarray analysis and transplantation of islets under the kidney capsule of streptozotocin-induced diabetic immune-deficient mice, respectively. Blood glucose levels of these mice were monitored weekly post-transplantation for >100 days, and islet grafts were collected and evaluated for the presence of endocrine cells. Results The genes involved in extracellular components, cell adhesion, glucose metabolism, and inflammatory response are differentially expressed between GMP and WT pig islets. Variation in the ability of pig islets in correcting the diabetic state of the mouse recipients appears to be dependent on the pig donor. In addition, prolonged cold ischemia time had a negative effect on the transplant outcome. All normoglycemic mice were able to respond well to glucose challenge despite the initial differences in the ability of islet transplants to reverse their diabetic state. Islet xenografts of normoglycemic mice contained abundant insulin- and glucagon-positive cells. Conclusion The effect of GMP and WT neonatal pig islet transplants on hyperglycemia in mice appears to be dependent on the pig donor, and prolonged cold ischemia time negatively affects the neonatal pig islet transplant outcome.

This study compared the quality of healthcare before and after implementation of a policy restructuring the healthcare delivery system and estimated the impact of centralization.We used the National Clinical Database to study patients undergoing esophagectomies from 2011 to 2016. We compared the effect of centralization based on the patient background, surgical mortality, and year of surgery. Difference-in-difference methods based on the generalized estimating equation logistic regression model were used for before-and-after comparisons after adjusting for patient-level expected surgical mortality.In total, 34,640 cases were identified. More cases with risk factors were noted in ultra-low-volume hospitals, where 38.4% of cases in underpopulated areas were treated, than in higher volume facilities, and the operative mortality, readmission within 30 days and length of stay were worse among patients treated in these hospitals. In centralized prefectures, the number of cases per hospital increased over time (7.2 in 2011 to 9.5 in 2016) while the crude operative mortality tended to decrease (3.4% in 2011 to 1.8% in 2016). The difference-in-difference estimator was 0.856 (95% confidence interval: 0.639-1.147, p = 0.298).The centralization of ultra-low-volume hospitals did not lead to a deterioration in the quality of care but rather an improving trend.

To evaluate the reliability of data collected from the gastroenterological section of the National Clinical Database of Japan (NCD), which began registrations in 2011 with ten surgical subspecialty societies. During 2014 and 2015, 1,136,700 cases involving 115 procedures at 4374 hospitals were registered in the gastroenterological surgery section of the NCD. After a test audit using the 2014 data, 17 hospitals were selected for the first audit and data verification for 2015. The data accuracy of patient demographics, surgical outcomes, and processes was assessed using 45 items from the cases registered, in comparison with the medical records. In the first audit of the 2015 data, case registration accuracy verification involved 338 patients (99.4% of the extracted cases). The data accuracy with the maximum postoperative variables was > 95%. Accuracy of the mortality and status 30 days after the surgery was high (> 99%) with a sensitivity of 1.00 and a specificity of 1.00. Among the six complications studied, the recorded cases had high specificity but lower sensitivity (0.70–0.89). We verified the data from the gastroenterological section of the NCD and found high accuracy of data entry.

Aim A comprehensive description of morbidity and mortality risk factors for post liver transplant has not been available to date. In this study, we established real‐time risk models of postoperative morbidities and mortality in liver transplant recipients using two Japanese nationwide databases. Methods Data from two Japanese nationwide databases were combined and used for this study. We developed real‐time prognostic models for morbidity and mortality from a derivation cohort (n = 1472) and validated the findings with an independent cohort (n = 395). Preoperative variables (C1), preoperative and intraoperative variables (C2), and all variables including postoperative morbidities within 30 days (C3) were analyzed to evaluate the independent risk factors for postoperative morbidity and mortality. Results We established real‐time risk models for morbidity and mortality. Areas under the curve (AUC) of C1 and C2 risk models for mortality were 0.74 (0.63‐0.82) and 0.79 (0.69‐0.86), respectively. Multivariate logistic analysis using C3 showed that hemoglobin 48 hours, coma >24 hours, renal dysfunction, postoperative systemic sepsis, and serum total bilirubin ≥10 mg/dL) represented independent risk factors for mortality (AUC = 0.87, 95% confidence interval [CI]: 0.78‐0.93). Conclusions Real‐time risk models of postoperative morbidities and mortality at various perioperative time points in liver transplant recipients were established. These novel approaches may improve postoperative outcomes of liver transplant recipients. Furthermore, these real‐time risk models may be applicable to other surgical procedures.

Background The current status and adoption of cancer-related clinical practice guidelines in Japan has not been elucidated yet. The purpose of this study was to propose roles and suggestions to develop future cancer-related clinical guidelines. Methods A questionnaire consisting of four domains with a total of 17 questions was developed. We distributed the questionnaire to 28 specific academic organizations in Japan which have developed any cancer-related clinical practice guidelines and which were funded by the Ministry of Health, Labor, and Welfare. Results Most organizations have investigated nationwide dissemination and adoption of clinical practice guidelines. The rate of adoption in clinical practice was estimated at approximately ≥ 70%. However, organizations with smaller budgets reported surveying approximately 60% of the time, whereas the ones with larger budgets reported approximately 100% success in surveying about their guidelines. The presidents of the organizations agreed that a new organization operated directly by the national government was necessary. Conclusion In Japan, to develop cancer-related clinical practice guidelines, a study of clinical validation is necessary. Sufficient funds must be available to support the project to maintain and revise the guidelines. Furthermore, legal and ethical issues should be solved before establishing any registry system.

Objective Nationwide databases are expected to provide critical data to improve medical practice. The present study used such data to develop risk models for clinically important outcomes after right hemicolectomy based on preoperative risk factors. Methods Japan's National Clinical Database (NCD) identified 38 030 cases of right hemicolectomy in the years 2011 and 2012. These were used to analyze correlations between mortality and eight selected clinical outcomes of interest by Pearson's correlation coefficient (r). To construct risk models for the eight selected clinical outcomes, 80% of all the examined cases were extracted randomly as a development cohort, and preoperative risk factors for each clinical outcome were identified using a forward stepwise selection method. Morbidities predicted from the risk models were used to find areas under the receiver operator curves among the remaining 20% of the testing cohort. Results The following clinical outcomes were identified as highly associated with operative mortality: systemic sepsis (r = .360), renal failure (r = .341), unplanned intubation (r = .316) and central nervous system (CNS) occurrences (r = .301). Risk models containing up to 21 preoperative variables were constructed for these eight postoperative clinical outcomes. Predictive values of the eight models were as follows: surgical site infections (0.634), anastomotic leakage (0.656), systemic sepsis (0.816), pneumonia (0.846), unplanned intubation (0.838), renal failure (0.883), CNS occurrences (0.833) and transfusion >5 units (0.846). Conclusions This study indicated that the NCD‐generated risk models for six of the eight selected critical postoperative outcomes had high discrimination among right hemicolectomy patients. These risk models can accurately identify high‐risk patients prior to surgery., This article is the first study that shows risk models for eight clinically important factors for morbidity after right hemicolectomy, based on preoperative risk factors. Our models and their evaluations are based on data from the NCD in Japan for the years 2011 and 2012.

In Japan, there have been no national surveys on the incidence of de novo malignancy after solid organ transplantation, which is one of the leading causes of death in transplant recipients. A questionnaire was distributed to institutions that perform solid organ transplantation in Japan, and clinical information was collected from patients who underwent transplantation between 2001 and 2010 and who exhibited de novo malignancies. Nine thousand two hundred ten solid organ transplants (kidney, 49.9%; liver, 45.9%; heart, 0.9%; lung, 1.2%; pancreas, 1.9%; small intestine, 0.2%) were performed. Four hundred seventy-nine (5.2%) cases of de novo malignancy were identified. The transplanted organs of the patients included the kidney (n = 479, 54.8%), liver (n = 186, 38.8%), heart (n = 5, 0.1%), lung (n = 18, 3.8%), pancreas (n = 9, 1.9%), and small intestine (n = 1, 0.02%). The most common malignancies were post-transplant lymphoproliferative disorder (n = 87) and cancers of the kidney (n = 43), stomach (n = 41), large intestine (n = 41), and lung (n = 36). This is the first national survey of the incidence of de novo malignancy in Japan. Further study is required to identify the risk of de novo malignancy in organ transplant recipients in comparison to the general population, namely the standardized incidence ratio.

Background Low anterior resection is associated with a relatively high incidence of postoperative morbidities, including anastomotic leakage and other operative site infections, which sometimes result in postoperative mortality. Therefore, recognition of the incidence and risk factors of postoperative complications following low anterior resection is essential. Methods Data from the National Clinical Database on patients who had undergone low anterior resection in 2011 and 2012 were retrospectively analyzed. Multiple logistic regression analyses were performed to generate predictive models of postoperative complications. Receiver-operator characteristic curves were generated, and the concordance index was used to assess the model's discriminatory ability. Results The number of patients who had undergone low anterior resection was 33,411. Seven complications, namely, overall operative site infections except for leakage, anastomotic leakage, urinary tract infection, pneumonia, renal failure, systemic sepsis, and cardiac events, were selected to construct statistical risk models. The concordance indices for the first 2 complications, which were dependent on the operative procedure, were relatively low (0.593–0.625), and the other 5, unrelated to operative procedures, showed high concordance indices (0.643–0.799). Conclusion This study created the world's second risk calculator to predict the complications of low anterior resection as a model based on mass nationwide data. In particular, this model is the first to predict anastomotic leakage.

The present retrospective multi-center study aimed to evaluate the efficacy and feasibility of nanoparticle albumin-bound (nab)-paclitaxel plus carboplatin as a second or late-phase chemotherapy in patients with non-small cell lung cancer (NSCLC). A total of 25 patients with recurrent or advanced NSCLC who had received previous chemotherapy were treated with nab-paclitaxel (70–100 mg/m2, intravenously) on days 1, 8 and 15 every 28 days with a carboplatin area under the concentration-time curve of 4–6 on day 1. The overall response rate, disease control rate, progression-free survival (PFS), overall survival (OS) and toxicities were statistically evaluated. Of the 25 patients, there were 9 cases of recurrent disease following surgery, 16 cases of advanced disease, 13 cases of adenocarcinoma, 11 cases of squamous cell carcinoma and 1 case of large cell carcinoma. A total of 13 patients received second-line chemotherapy and 12 received fourth-line or later chemotherapy. One patient exhibited a complete response, 7 had a partial response, 10 exhibited stable disease and 7 had progressive disease. The overall response rate was 32.0% and the disease control rate was 72.0%. The median PFS and median OS following nab-paclitaxel treatment were 4.0 and 14.0 months, respectively. Frequent treatment-associated adverse events were myelosuppression, peripheral neuropathy, gastrointestinal symptoms and baldness, the majority of which were grade 1–2. Grade 3–4 neutropenia, thrombocytopenia and anemia occurred in 7 (28.0%), 3 (12.0%) and 2 (8.0%) patients, respectively. No patients experienced grade 3–4 sensory neuropathy and no grade 5 adverse effects were observed. Nab-paclitaxel plus carboplatin as second-phase or later chemotherapy provided a small but significant survival benefit for patients with recurrent or advanced NSCLC, with tolerable adverse effects. To the best of our knowledge, the results of the present study demonstrated for the first time that nab-paclitaxel plus carboplatin is a promising and feasible late-phase chemotherapeutic agent for NSCLC.

Background The morbidity rate after pancreaticoduodenectomy remains high. The objectives of this retrospective cohort study were to clarify the risk factors associated with serious morbidity (Clavien–Dindo classification grades IV–V), and create complication risk calculators using the Japanese National Clinical Database. Methods Between 2011 and 2012, data from 17,564 patients who underwent pancreaticoduodenectomy at 1,311 institutions in Japan were recorded in this database. The morbidity rate and associated risk factors were analyzed. Results The overall and serious morbidity rates were 41.6% and 4.5%, respectively. A pancreatic fistula (PF) with an International Study Group of Pancreatic Fistula (ISGPF) grade C was significantly associated with serious morbidity (P