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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.

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.

In developing a formula for manual use in clinical settings, simplicity is as important as accuracy. Whole-liver (WL) mass is often estimated using demographic and anthropometric information to calculate the standard liver volume or recommended graft volume in liver transplantation. Multiple formulas for estimating WL mass have been reported, including those with multiple independent variables. However, it is unknown whether multivariable models lead to clinically meaningful improvements in accuracy over univariable models. Our goal was to quantitatively define clinically meaningful improvements in accuracy, which justifies an additional independent variable, and to identify an estimation formula for WL graft weight that best balances accuracy and simplicity given the criterion. From the Japanese Liver Transplantation Society registry, which contains data on all liver transplant cases in Japan, 129 WL donor-graft pairs were extracted. Among the candidate models, those with the smallest cross-validation (CV) root-mean-square error (RMSE) were selected, penalizing model complexity by requiring more complex models to yield a ≥5% decrease in CV RMSE. The winning model by voting with random subsets was fitted to the entire dataset to obtain the final formula. External validity was assessed using CV. A simple univariable linear regression formula using body weight (BW) was obtained as follows: WL graft weight [g] = 14.8 × BW [kg] + 439.2. The CV RMSE (g) and coefficient of determination (R2) were 195.2 and 0.548, respectively. In summary, in the development of a simple formula for manually estimating WL weight using demographic and anthropometric variables, a clinically acceptable trade-off between accuracy and simplicity was quantitatively defined, and the best model was selected using this criterion. A univariable linear model using BW achieved a clinically optimal balance between simplicity and accuracy, while one using body surface area performed similarly.

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.

The Japanese Society of Gastroenterological Surgery (JSGS) and the American College of Surgeons National Surgical Quality Improvement Program (ACS‐NSQIP) have collaboratively developed several clinical projects since 2011 using two nationwide clinical registries with the goal of achieving further improvement of surgical quality in both countries. In this review, the historical viewpoints and the collaboration between JSGS and ACS and their use of nationwide registries [National Clinical Database (NCD) and NSQIP] for research are reviewed. We have carried out a joint project, the 30‐day Mortality Risk Model Study and, currently, we are working on several joint projects such as the Morbidity‐Mortality Study, Japan‐USA Calibration Study, Geriatric Study, and Safety Culture Study as well as Auditing in JSGS/NCD with reference to the NSQIP method. These joint projects will continue to provide us with important information and data to drive improvements in surgical care in both countries. This will also help us to identify any unknown weaknesses in the health‐care systems of the USA and Japan.

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.

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.

Strategies to reduce the immunogenicity of pancreatic islets and to prevent the activation of proinflammatory events are essential for successful islet engraftment. Pretransplant islet culture presents an opportunity for preconditioning to improve outcomes of islet transplantation. We previously demonstrated that ex vivo mitomycin C (MMC) pretreatment and subsequent culture significantly prolonged graft survival. Fully understanding the biological process of pretreatment could result in the development of a protocol to improve the survival of islet grafts. Microarrays were employed to conduct a comprehensive analysis of genes expressed in untreated or MMC-treated rat islets that were subsequently cultured for 3 d. A bioinformatics software was used to identify biological processes that were most affected by MMC pretreatment, and validation studies, including in vivo and in vitro assay, were performed. The gene expression analysis identified significant downregulation of annotated functions associated with cellular movement and revealed significant downregulation of multiple genes encoding proinflammatory mediators with chemotactic activity. Validation studies revealed significantly decreased levels of interleukin 6 (IL-6), monocyte chemoattractant protein 3 (MCP-3), and matrix metallopeptidase 2 (MMP2) in culture supernatants of MMC-treated islets compared with controls. Moreover, we showed the suppression of leukocyte chemotactic activity of MMC-treated islets in vitro. We also showed that MMC-treated islets secreted lower levels of chemoattractants that synergistically reduced the immunogenic potential of islets. Histological and immunohistochemical analyses of the implant site revealed that infiltration of monocytes, CD3-positive T cells, and B cells was decreased in MMC-treated islets. In conclusion, the ex vivo pretreatment of islets with MMC and subsequent culture can reduce the immunogenic potential and prolong the survival of islet grafts by inducing the suppression of multiple leukocyte chemotactic factors.

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

Background Esophagectomy is a highly invasive procedure with a high incidence of complications. The objectives of this study were to create risk prediction models for postoperative morbidity associated with esophagectomy and to test their performance using a population-based large database. Methods A total of 10 862 patients who underwent esophagectomy between January 2011 and December 2012 derived from the Japanese national clinical database (NCD) were included. Based on the 148 preoperative clinical variables collected, risk prediction models for eight major postoperative morbidities were created using 80% (8715 patients) of the study population and validated using the remaining 20% (2147 patients) of the patients. Results The mortality rate was 3.1% and postoperative morbidity was observed in 42.6% of the patients. The c-statistics of the eight risk models established by the training set were surgical site infection (0.564), anastomotic leakage (0.531), need for transfusion (0.636), blood loss >1000 mL (0.644), pneumonia (0.632), unplanned intubation (0.607), prolonged mechanical ventilation over 48 hours (0.614), and sepsis (0.618) in the validation analysis. Conclusions Risk prediction models for postoperative morbidity after esophagectomy using the population-based large database showed relatively fair performance. The current models may offer baseline information for risk stratification in clinical decision makings and help select more suitable surgical and nonsurgical treatment options and future clinical studies.

Background / Aim The National Clinical Database (NCD) in Japan is a nationwide registry that collects the data of more than 1,200,000 surgical cases annually from over 3500 hospitals. Based on the NCD data, this study compared the perioperative outcomes of major laparoscopic liver resection (LLR) with those of major open liver resection (OLR) using the propensity score matching method. Methods We collected data on 15,191 major hepatectomy cases (929 major LLR cases and 14,262 major OLR cases), and investigated the short-term outcomes in well-matched groups. Results In the LLR group, 30-day mortality, in-hospital mortality, and operative mortality were 0.9%, 1.7%, and 1.7% respectively. The mean blood loss in the LLR group (865.4 ± 1148.2 mL) was significantly less than in the OLR group (1053.8 ± 1176.6 mL), and the median postoperative hospital stay for the LLR patients (21.37 ± 19.71 days) was significantly shorter than for the OLR patients (26.25 ± 24.53 days). The complication rate in the LLR group (16.4%) was significantly lower than that in the OLR group (23.5%). Conclusion LLR in selected patients is currently safely performed as well as OLR even in patients requiring major hepatectomy, associated with less blood loss, shorter hospital stays, and fewer complications. This article is protected by copyright. All rights reserved.

The aim of this study is to evaluate the association between the participation of board-certified surgeons in gastroenterological surgery (BCS-Gs) and the surgical outcomes of gastroenterological surgery. Data from the National Clinical Database on patients who underwent eight major gastroenterological procedures were analyzed retrospectively. First, the ratio of cases in which BCS-G were involved to the total cases was calculated for each procedure, and the impact of BCS-G involvement on surgical outcome was assessed by comparing mortality rates in the group with BCS-G involvement vs. the group without BCS-G involvement. Second, the differences in the observed/expected ratio were assessed among four hospital categories according to the available BCS-G number. Finally, the impact of the hospital BCS-G number on mortality was evaluated. The ratio of BCS-G involvement ranged from 59.0 % for acute diffuse peritonitis to 89.1 % for hepatectomy, and the mortality rate was significantly lower for three procedures when BCS-Gs participated as the operator or assistant. The observed/expected ratio of hospitals with four or more BCS-Gs was less than 1.0 for all the procedures assessed. A multivariable logistic regression model showed that the hospital BCS-G number was a predictor of operative mortality. BCS-Gs contribute to favorable outcomes of gastroenterological surgery in Japan. The hospital BCS-G number is a surrogate marker of operative mortality.

Carcinoembryonic antigen (CEA) is a glycoprotein marker, which is widely used for diagnosing various cancers, especially colon adenocarcinoma. In addition, CEA mediates homotypic adhesion of colon adenocarcinoma cells, which appears to favor hematogenous metastasis. CEA carries α2,6sialyl residues on its N-glycans whereas a normal counterpart, normal faecal antigen-2, does α2,3sialyl residues, suggesting that cancer specific α2,6sialylation on CEA may play a role for cell invasion and metastasis. Here we report a simple and rapid estimation of α2,6sialyled-CEA in detergent extracts from formalin fixed colon adenocarcinoma by “lectin inhibition”. In the lectin inhibition method, Sambucus sieboldiana Agglutinin (SSA) lectin, an α2,6sialic acid binder, was used as a glycoform specific inhibitor for antigen-antibody reaction in ELISA. Detergent extracts from colon adenocarcinoma showed a fair amount of ELISA signal in the absence of SSA whereas the signal was markedly reduced (45∼74%) in the presence of SSA, suggesting that the extracts contains α2,6sialyled-CEA. The presence of α2,6sialyled-CEA in the extracts was confirmed by lectin microarray, in which SSA, Sambucus nigra agglutinin, and Trichosanthes japonica agglutinin I lectins were used as α2,6sialyl-binders. Thus lectin inhibition is a simple and rapid method for detecting α2,6sialyled-CEA even in crude detergent extracts from formalin-fixed adenocarcinoma tissue. This article is protected by copyright. All rights reserved

BACKGROUND The objective of this study was to validate the board certification system of the Japanese Society of Hepato-Biliary-Pancreatic Surgery (JSHBPS) using the data of hepatectomy cases from the National Clinical Database (NCD) of Japan. METHODS Minimal required annual numbers of high-level hepato-biliary-pancreatic (HBP) surgeries were 50 for a board-certified A training institution and 30 for a board-certified B training institution. Records of 14,970 patients who had undergone hepatectomy of more than one segment (MOS), excluding lateral segmentectomy, during 2011 and 2012 were analyzed according to the category of board-certified institution and with or without participation of board-certified instructors or expert surgeons. RESULTS Thirty-day mortality and operative mortality of 14,970 patients after MOS hepatectomy were 1.9% and 3.8%, respectively. Operative mortality rates after MOS hepatectomies performed at certified A institutions, certified B institutions, and non-certified institutions were 3.1%, 3.8%, and 4.5%, respectively (P < 0.001). The operative mortality rates after MOS hepatectomies performed with participation of certified instructors or expert surgeons were better than those without (3.5% vs. 4.3%, P = 0.012). A multiple logistic regression model showed that the cutoffs of high-level HBP surgeries performed per year at hospitals that predicted operative mortality after MOS hepatectomies were 10 and 50. CONCLUSIONS Competences and requirements for board-certified institutions, instructors, and expert surgeons to perform hepatectomy were found to be appropriate.

The mechanism of anti-tumor effect of transarterial Immuno-Embolization (TIE) using OK-432 has not been well elucidated. In this study, we aimed to investigate the tissue injury and immune response after portal venous embolization (PVE) with/without OK-432. Embolic materials (L group: lipiodol, LF group: lipiodol+fibrinogen, LO group: lipiodol+OK-432, LFO group: lipiodol+fibrinogen+OK-432) were administered via the right portal vein in Wistar rats. The histological findings in LFO group demonstrated liver damage with severe architectural changes. The concentrations of CD68(+) cells were observed in a time-dependent manner; it was significantly increased in the LO group on day 1 and in the LFO group on day 3. CD68(+)CD163(-) macrophages significantly increased in the LFO group on day 7 (P

Background Preoperative transarterial immunoembolization (TIE) for hepatocellular carcinoma (HCC) is effective for preventing recurrence. We aimed to investigate the intratumoral and peritumoral M1 macrophage-induced immune response following TIE treatment. Methods We compared 13 patients treated with TIE between 2003 and 2009 (TIE group) and 13 patients treated with surgery alone during the same period of time at our institute (control group) using an immunohistological study with CD68 and CD163 antibodies. Results No significant differences in clinicopathological characteristics, except for surgical time, were observed between the two groups. The 3-year recurrence-free survival outcome of the TIE group was quite different from that of the control group (100% vs. 38.5%, P = 0.034). In the histological investigation, lytic necrosis and coagulation necrosis of the main tumor along with the presence of multinuclear giant cells were observed in 10 of the 13 patients in the TIE group. The immunohistological study showed that not only the numbers of intratumoral CD68(+) cells, but also the numbers of intratumoral and peritumoral CD8(+) cells were significantly increased in the TIE group. Conclusions The suppression of tumor recurrence induced by preoperative TIE might be induced by intratumoral M1 macrophages that are activated by OK-432 and fibrinogen.

Biologic or biomechanical therapy capable of replacing the β cell mass has the potential to positively impact the health and well being of millions of people with insulindependent diabetes. Research in this area stands at a pivotal moment at which a number of viable strategies exist or are under development. Broad application depends on achieving both technical and financial feasibility. The ultimate goal of a "true cure," in which diabetic individuals achieve euglycemia with a single procedure associated with minimal risk, without long-termtoxic drugs, and unfettered by external devices and/or frequent monitoring, appears to still be some years away. However, dramatic progress has been achieved toward themore proximate objectives of improved glycemic control and elimination of hypoglycemia and long-term vascular complications. Long-term whole organ pancreas and isolated islet results have improved significantly over the last decade,with the latter now approaching the success of the former in insulin independence rates at the 5-year mark. It seems likely that allogeneic pancreas and islet transplantation will remain a treatment of choice for the foreseeable future in kidney recipients already obligated to lifelong immunosuppression until a more complete and permanent restoration of euglycemia is available. Nascent tolerance promoting protocols could aid in improving the risk-to-benefit balance for both islets and whole organ pancreas. With the present supply of transplantable pancreases used optimally, nomore than 13% of the annual incident cases of T1D can be cured. In practical terms though, today, fewer than 5% of the annual incident cases are transplanted. The reality of the limited supply of deceased donor organs ultimately constrains the impact of islet and pancreas transplantation and compels researchers to press forward to develop broader strategies such as the AP, xenogeneic islets, and stem cell-derived β cells for which the supply will be limitless; in these areas, recent progress has been most impressive. The AP continues to be refined withmore sophisticated delivery algorithms, improved sensors and exploration of mobile device control. For xenogeneic islets, dramatic progress is evident in the long-term survival of porcine islets in primates using genetically modified donors and/or improved biologic immunosuppressants. Microencapsulation and macroencapsulation devices that exclude direct immunity by physical means may further aid in fostering xenogeneic islet graft survival but will likely find their primary place in the containment and protection of early versions of stem cell-derived allogeneic β cells. Deriving functional β cells from stem cells has experienced the most celebrated recent advances. Improved differentiation protocols that permit large scale/ unlimited production of IPCs are nowavailable, and although "normal" β-cell function has not yet been achieved, the ever quickening pace of progress suggests they are not far off. Importantly, this therapeutic modality will ultimately need to confront the likely requirement for a containment device and the need to be retransplanted periodically. These blemishes notwithstanding, the tremendous perceived potential of the approach for clinical application is evident in the huge venture capital investment that was rapidly garnered after the report of the most recent advance in embryonic stem cell differentiation into proper β cells. Consistent with the informal survey we conducted, iPS-derived β cells, which currently suffer from regulatory hurdles and the lack of a viable business model, and the seemingly more remote regeneration of native β cells,may offer the ultimate chance for a personalized true cure of insulin-dependent diabetes by avoidance of barrier devices and toxic immunosuppressive drugs. The research agenda we have detailed is designed to facilitate full exploration of the potential of each proposed β-cell replacement solution so the optimal therapy is advanced as quickly as possible. Success in this endeavor will require broad and deep financial support from philanthropic (JDRF, Diabetes Research and Wellness Foundation, ADA, and so on) and public funding agencies worldwide; the investment needed is large but the potential reward will be profound. It is imperative that high impact, scientifically sound approaches are not overwhelmed by industry, private, or venture capital-supported priorities just because they hold a more lucrative near-term business model; scientific merit should dictate the course. The adherence of the historical funding agencies to traditional peer-reviewed methodology will be the incubator of novel approaches. This is a rapidly evolving landscape, and new data and novel ideas may radically divert the path forward. However, the diverse recent progress is tangible and undeniable, and the next decade is bound to witness a fascinating unfolding of competing solutions to cure insulin-dependent diabetes. Our assessment of the data presented creates the opportunity for IPITA/TTS to endorse the following broad agenda for specific support by the peer-reviewed agencies.

Crizotinib, the first clinically available inhibitor of anaplastic lymphoma kinase (ALK) gene rearrangement, is generally well tolerated. In contrast, neutropenia induced by crizotinib is a commonly reported grade 3 or 4 adverse event. In such cases, interruption and dose reduction of crizotinib might be necessary for some patients with severe neutropenia. However, information concerning clinical experience and management of severe neutropenia is currently limited. In this report, the successful management of crizotinib-induced neutropenia by dose reduction of crizotinib in a patient with ALK-positive non-small cell lung cancer is described.

Radiofrequency ablation (RFA) is a useful tool for local control of unresectable pulmonary neoplastic lesions. However, RFA is limited to tumors smaller than 4 cm and peripheral lesions. The sensitivity and specificity of FDG-PET are higher than those of computed tomography. FDG-PET at 3 to 6 months after RFA is important for predicting recurrence. Complications associated with RFA, such as infection and abscess formation, which concentrate glucose in the ablation area, can cause false-positive findings in PET examination. Knowledge of the morphologic imaging features of these complications is important in avoiding these potential pitfalls.

The current status of site-specific cancer registry has not been elucidated, but sufficient system is found in some societies. The purpose of this study was to clear the present condition of site-specific cancer registries in Japan and to suggest for the improvement. The questionnaire was conducted by the study group of the Ministry of Health, Labor, and Welfare. It consisted of 38 questions, conflicts of interest, clinical research method, informed consent and funding for registry. We distributed this questionnaire to 28 academic societies, which had published the clinical practice guideline(s) assessed under Medical Information Network Distribution Service (MINDS). The concept of the importance in assessment for medical quality by the data of the site-specific cancer registry was in good consensus. But the number of the society with the mature registry was limited. The whole-year registry with the scientific researches in the National Clinical Database (NCD) and in the Translational Research Informatics Center (TRI) might seem to be in success, because assured enhancement may be estimated. Now, academic societies have the structural factors, i.e., the financial limitation in the registry maintenance and the data analysis, and in the difficulty of employment of the researchers with skill and talent. To manage the site-specific cancer registry effectively, the scientific registry system will be essentially important. Each academic society had much experienced highly qualified clinical researches in past. Accordingly, the scientific suggestion and co-operation should be of great importance for the improvement.

There is a risk of developing a fatal trachea-innominate artery fistula following laryngotracheal separation for the prevention of intractable aspiration pneumonia. We developed a novel technique of surgical closure of the larynx to avoid this complication and provide long-term cannula-free care.

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

Personalized therapy for non-small cell lung cancer (NSCLC), particularly lung adenocarcinoma, has recently been significantly improved by the discovery of various molecular targets. However, this has not been the case for lung squamous cell carcinoma (SCC). In the present study, we identified the family with sequence similarity 83, member B (FAM83B) as a candidate marker for SCC through a comprehensive gene expression analysis and examined its correlations with various clinicopathological factors. The subjects of this study consisted of 215 patients with NSCLC who underwent complete resection from 2005 to 2011 at the Fukushima Medical University Hospital (Fukushima, Japan). They included 102 patients with adenocarcinoma and 113 with SCC. FAM83B expression was first examined in some of the samples by gene expression analysis and western blotting, and then all clinical specimens were evaluated by immunohistochemistry (IHC). The relationship between the quantitative values for IHC and clinicopathological factors was statistically analyzed. The results showed that FAM83B mRNA expression was significantly higher in SCC than in normal lung or adenocarcinoma (P10% positive area for FAM83B were judged as ‘positive’; 94.3% (107/113) of SCC and 14.7% (15/102) of adenocarcinoma were positive. Patients were divided into two subgroups according to expression (54 high-expression and 53 low-expression patients); the high-expression group was associated with a better disease-free survival (DFS) rate (P=0.042, log-rank test). In conclusion, FAM83B may be a reliable diagnostic and prognostic biomarker for SCC. Detailed analyses of FAM83B function in lung cancer are required to understand how its expression is associated with better prognosis in SCC.

Highlights • A graft hepatic artery we experienced too short to rotate a microclamp in living donor liver transplantation. • We performed two-step hepatic artery reconstruction. • In the first step, we cut the recipient right hepatic artery and used it as an arterial graft. • The graft hepatic artery was coapted to the distal stump of the arterial graft without a microclamp. • In the second step, the proximal stump of the arterial graft was coapted to the recipient right hepatic artery., Introduction We describe successful two-step hepatic artery reconstruction in a patient whose graft site hepatic artery was too short for the use of a microclamp in living donor liver transplantation. Presentation of case A 57-year-old woman was diagnosed as having hepatitis C and liver cirrhosis. Her 26-year-old son was the living liver donor. The living donor underwent right lobectomy. The dissected graft hepatic artery was too short for the use of a microclamp. The recipient right hepatic artery was cut and used as an arterial graft. The graft right hepatic artery was sutured to the right hepatic artery of the arterial graft and the graft posterior branch of the right hepatic artery was sutured to the middle hepatic artery of the arterial graft. After reconstruction of the portal vein and hepatic vein was completed, anastomosis was performed between the graft right hepatic artery and right hepatic artery. The patency of the vessels was checked using color Doppler ultrasonography for 1 week postoperatively. No postoperative complications involving blood flow of the hepatic artery were observed. Discussion In our case, the recipient hepatic artery was cut and used as an arterial graft. Although the number of anastomotic sites of the hepatic artery increased, we could perform hepatic artery reconstruction safely and easily. Conclusion Two-step hepatic artery reconstruction is a useful method in cases where the recipient hepatic artery does not have enough length.

A 55-year old man underwent distal gastrectomy with lymphadenectomy for gastric cancer(T1N0M0, Stage I A). Six months after the radical operation, he presented with multiple liver metastases. Based on immunohistochemical examination, he was diagnosed with AFP-producing gastric cancer and metachronous liver metastases. He underwent a surgery to remove the liver metastases. Two months after the surgery, recurrent tumors were found in the lung and remnant liver. He received chemotherapy(S-1/CDDP and CPT-11/CDDP)for the recurrent tumor and lived for 15 months after the surgical intervention.

A 67-year-old man suffered from obstructive jaundice due to distal bile duct cancer. He underwent surgery after percutaneous biliary drainage and did not received adjuvant chemotherapy afterwards. Two years after surgery, some subcutaneous nodules were detected in the left axilla and the lateral chest on enhanced CT imaging. The nodules were diagnosed as metachronous distant metastases from bile duct cancer based on pathological findings. He was treated postoperatively with S-1 and new lesions have not been detected during the 3 months after the surgery. Surgical intervention in combination with chemotherapy might be beneficial in selected patients with recurrent bile duct cancer.

The cancer registry is an essential part of any rational program of evidence-based cancer control. The cancer control program is required to strategize in a systematic and impartial manner and efficiently utilize limited resources. In Japan, the National Clinical Database (NCD) was launched in 2010. It is a nationwide prospective registry linked to various types of board certification systems regarding surgery. The NCD is a nationally validated database using web-based data collection software; it is risk adjusted and outcome based to improve the quality of surgical care. The NCD generalizes site-specific cancer registries by taking advantage of their excellent organizing ability. Some site-specific cancer registries, including pancreatic, breast, and liver cancer registries have already been combined with the NCD. Cooperation between the NCD and site-specific cancer registries can establish a valuable platform to develop a cancer care plan in Japan. Furthermore, the prognosis information of cancer patients arranged using population-based and hospital-based cancer registries can help in efficient data accumulation on the NCD. International collaboration between Japan and the USA has recently started and is expected to provide global benchmarking and to allow a valuable comparison of cancer treatment practices between countries using nationwide cancer registries in the future. Clinical research and evidence-based policy recommendation based on accurate data from the nationwide database may positively impact the public.

The health-care system, homogenous ethnicity, and operative strategy for lower rectal cancer surgery in Japan are to some extent unique compared to those in Western countries. The National Clinical Database is a newly established nationwide, large-scale surgical database in Japan.To illuminate Japanese national standards of clinical care and provide a basis for efforts to optimize patient care, we used this database to construct a risk model for a common procedure in colorectal surgery-low anterior resection for lower rectal cancer.Data from the National Clinical Database on patients who underwent low anterior resection during 2011 were analyzed. Multiple logistic regression analyses were performed to generate predictive models of 30-day mortality and operative mortality. Receiver-operator characteristic curves were generated, and the concordance index was used to assess the model's discriminatory ability.During the study period, data from 16,695 patients who had undergone low anterior resection were collected. The mean age was 66.2 years and 64.5% were male; 1.1% required an emergency procedure. Raw 30-day mortality was 0.4% and operative mortality was 0.9%. The postoperative incidence of anastomotic leakage was 10.2%. The risk model showed the following variables to be independent risk factors for both 30-day and operative mortality: BMI greater than 30 kg/m, previous peripheral vascular disease, preoperative transfusions, and disseminated cancer. The concordance indices were 0.77 for operative mortality and 0.75 for 30-day mortality.The National Clinical Database is newly established and data entry depends on each hospital.This is the first report of risk stratification on low anterior resection, as representative of rectal surgery, with the use of the large-scale national surgical database that we have recently established in Japan. The resulting risk models for 30-day and operative mortality from rectal surgery may provide important insights into the delivery of health care for patients undergoing GI surgery worldwide.

Background Pancreatic islet transplantation has emerged as an effective treatment for type 1 diabetes mellitus, but its use is limited due to an insufficient supply of cadaveric pancreata. In Japan, uncontrolled donors after cardiac death (DCD) are not deemed to be suitable for whole-organ pancreatic transplantation, and can provide a source of pancreas for islet transplantation. However, the long-term outcomes and utility of uncontrolled DCD in the clinical setting remain controversial. Here, we summarize the long-term outcomes of islet transplantation employing uncontrolled DCD as reported to the Japan Islet Transplantation Registry. Methods Sixty-four isolations and 34 transplantations of pancreatic islets were conducted in 18 subjects with type 1 diabetes mellitus under the cover of immunosuppression with basiliximab, sirolimus, and tacrolimus. All donors were uncontrolled DCD at the time of harvesting. The mean follow-up time was 76 months. Results Of the 18 recipients, 8, 4, and 6 recipients received 1, 2, and 3 islet infusions, respectively. Overall graft survivals (defined as a C-peptide level ≥0.3 ng/mL) were 72.2%, 44.4%, and 22.2% at 1, 2, and 5 years, respectively, whereas the corresponding graft survivals after multiple infusions were 90.0%, 70.0%, and 30.0%, respectively. Three of these recipients achieved insulin independence in 14, 79, and 215 days. HbA1c levels and the requirement of exogenous insulin were improved before loss of graft function. All recipients became free of severe hypoglycemia unawareness, however, at least 5 of 14 patients who had graft failure experienced recurrence of severe hypoglycemia after the loss of graft function. Conclusions Islet transplantation from DCD can relieve glucose instability and problems with hypoglycemia when the graft is functioning. However, islets from uncontrolled DCD may be associated with reduced long-term graft survival. Further improvements in the clinical outcome by modification of islet isolation/transplantation protocols are necessary to establish islet transplantation using DCD.

Computed tomography (CT)-guided radiofrequency ablation (RFA) is safe and effective for patients with unresectable primary, recurrent, or metastatic thoracic malignancies. Several studies have shown the benefit of employing 18-fluoro-deoxyglucose positron-emission tomography (FDG-PET) to follow thoracic malignancies treated with RFA. In this prospective study, we show the safety and therapeutic efficacy of RFA and the utility of FDG-PET as tool for early detection of local recurrence. Twenty patients were enrolled in this study, and 24 lesions were ablated. Seven lesions were primary lung cancer, and 17 lesions were recurrent tumors or metastases from extrathoracic sites. Tumor size was in the range of 0.4–3.3 cm in diameter (mean: 1.5 cm). CT and FDG-PET scans were scheduled 7–14 days and 3–6 months after RFA treatment. There were 17 adverse events (70.8 %) in 24 ablations included 13 pneumothoraces, two cases of chest pain, and two episodes of fever. With a median follow-up of 35.9 months (range 1–62 months), the overall 2-year survival rate was 84.2 %. Local recurrence occurred at four sites (2-year local control rate was 74.3 %). The FDG-PET results 7–14 days after RFA did not predict recurrence, whereas positive findings 3–6 months after RFA significantly correlated with local recurrence (p = 0.0016). We confirmed the effectiveness of RFA for unresectable primary and secondary thoracic malignancies. FDG-PET analysis 3–6 months after ablation is a useful tool to assess local control.