Tele-proctoring for minimally invasive surgery across Japan: An initial step toward a new approach to improving the disparity of surgical care and supporting surgical education.

Aim: The aim of this study was to verify the clinical feasibility of tele-proctoring using our ultra-low latency communication system with shared internet access. Methods: Connections between two multiple remote locations at various distances were established through the TELEPRO® tele-proctoring system. The server records the latency between the two locations for tele-proctoring using the annotations. Questionnaires were administered to the surgeons, assistants, and medical staff. Respondents rated the quickness and quality of communication in terms of latency and disturbances in the audio, video, and usefulness of the live telestrations with annotation. Results: Seven hospitals tele-proctored with Sapporo Medical University between January 2021 and September 2022. The median latency of annotation between the two locations ranged from 24.5 to 48.5 ms. No major technological problems occurred, such as streaming interruption, loss of video or audio, poor resolution. The video encoding time was 10 ms, and its decoding time was 0.8 ms. The total latency positively correlated with the distance between two locations (R = 0.55, p < 0.01). The quality of communication regarding latency, disturbance, and surgical education with intraoperative annotative instructions showed similar trends, with perfectly fine being the most common response. No significant differences in surgical quality, educational effect, or social impact were observed between the latency ≥30 and <30 ms groups for whether the size of latency affects surgical education. Conclusion: The feasibility of the tele-proctoring system is expected to be a sustainable approach to help education for young surgeons and surgical supports in rural areas, thereby reducing disparities in health care.

Gender equity in surgical instruments: ergonomics of ring-handled forceps.

INTRODUCTION: Female surgeons have ergonomic issues with commercialized instruments tailored for male surgeons. The purpose of this study was to identify satisfaction levels and ergonomic problems of female surgeons while using laparoscopic forceps with ring-handles and suggest improvement measures. MATERIAL AND METHODS: A questionnaire was sent to 19,405 members of the Japanese Society of Gastroenterological Surgery via email between 1 August 2022 and 30 September 2022. It included demographic information and specific questions regarding the use of laparoscopic forceps with ring- handles (ergonomic evaluation, influence of the negative aspects of laparoscopic forceps during surgery, physical discomfort in the hands and fingers, degree of satisfaction, and handle size). RESULTS: Valid responses were received from 1,030 respondents (131 female and 899 male surgeons). The ergonomics of the laparoscopic forceps with ring-handles were rated lower by female surgeons in all ten categories (all p value < 0.05). They also reported a negative impact on surgical manipulation and discomfort to their hands and fingers. CONCLUSIONS: Female surgeons had a wide variety of ergonomic problems when using laparoscopic forceps with ring-handles, and showed lower levels of satisfaction. Developing a different model tailored to female surgeons with smaller hands and a weaker grip could be a viable solution.

Cost-Effectiveness of Universal Asymptomatic Preoperative SARS-CoV-2 Polymerase Chain Reaction Screening: A Cost-Utility Analysis.

BACKGROUND: An early report has shown the clinical benefit of the asymptomatic preoperative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) screening test, and some clinical guidelines recommended this test. However, the cost-effectiveness of asymptomatic screening was not evaluated. We aimed to investigate the cost-effectiveness of universal preoperative screening of asymptomatic patients for SARS-CoV-2 using polymerase chain reaction (PCR) testing. METHODS: We evaluated the cost-effectiveness of asymptomatic screening using a decision tree model from a payer perspective, assuming that the test-positive rate was 0.07% and the screening cost was 8500 Japanese yen (JPY) (approximately 7601 US dollars [USD]). The input parameter was derived from the available evidence reported in the literature. A willingness-to-pay threshold was set at 5 000 000 JPY/quality-adjusted life-year (QALY). RESULTS: The incremental cost of 1 death averted was 74 469 236 JPY (approximately 566 048 USD) and 291 123 368 JPY/QALY (approximately 2 212 856 USD/QALY), which was above the 5 000 000 JPY/QALY willingness-to-pay threshold. The incremental cost-effectiveness ratio fell below 5 000 000 JPY/QALY only when the test-positive rate exceeded 0.739%. However, when the probability of developing a postoperative pulmonary complication among SARS-CoV-2-positive patients was below 0.22, asymptomatic screening was never cost-effective, regardless of how high the test-positive rate became. CONCLUSIONS: Asymptomatic preoperative universal SARS-CoV-2 PCR screening is not cost-effective in the base case analysis. The cost-effectiveness mainly depends on the test-positive rate, the frequency of postoperative pulmonary complications, and the screening costs; however, no matter how high the test-positive rate, the cost-effectiveness is poor if the probability of developing postoperative pulmonary complications among patients positive for SARS-CoV-2 is sufficiently reduced.

Specialty-Certified Colorectal Surgeons Demonstrate Favorable Short-term Surgical Outcomes for Laparoscopic Low Anterior Resection: Assessment of a Japanese Nationwide Database.

BACKGROUND: There are few studies on the impact of a colorectal-specific technically certified surgeon on good surgical outcomes for laparoscopic low anterior resection in the real world. OBJECTIVE: To evaluate the short-term outcomes of laparoscopic low anterior resection with the participation of a certified colorectal surgeon. DESIGN: This was a retrospective cohort study using a Japanese nationwide database. SETTING: This study was conducted as a project for the Japan Society of Endoscopic Surgery and the Japanese Society of Gastroenterological Surgery. PATIENTS: This study included 41,741 patients listed in the National Clinical Database who underwent laparoscopic low anterior resection performed by certified, noncertified, and colorectal-specific certified surgeons, according to the Endoscopic Surgical Skill Qualification System, from 2016 to 2018. MAIN OUTCOME MEASURES: Operative mortality rate and anastomotic leak rate were the primary outcome measures. RESULTS: Overall 30-day mortality and operative mortality were 0.2% and 0.3%, respectively, without significant differences between all kinds of certified and noncertified surgeon groups. Overall anastomotic leak rate was 9.3%, with a significant difference between the 2 groups. Colorectal- and stomach-certified groups had lower 30-day mortality and operative mortality than the biliary-certified and noncertified groups. The anastomotic leak rate was the lowest in the colorectal-certified group. Based on a logistic regression analysis using the risk-adjusted model, operative mortality was significantly higher in the biliary-certified group than in the colorectal-certified group. Moreover, anastomotic leak rate was significantly lower in the colorectal-certified group than in the stomach-certified and noncertified groups. LIMITATIONS: This study was a retrospective study, and there was a possibility of different definitions of anastomotic leak due to the use of a nationwide database. CONCLUSIONS: The participation of a colorectal-specific certified surgeon may decrease the risk of operative mortality and anastomotic leak for laparoscopic low anterior resection. CIRUJANO COLORRECTAL ALTAMENTE CALIFICADO PROVOCA RESULTADOS QUIRRGICOS FAVORABLES A CORTO PLAZO PARA LA RESECCIN ANTERIOR BAJA LAPAROSCPICA EVALUACIN DE LA BASE DE DATOS NACIONAL JAPONESA: ANTECEDENTES:Hay pocos estudios sobre el impacto de un cirujano certificado técnicamente especializado en cáncer colorrectal con un buen resultado quirúrgico para la resección anterior baja laparoscópica en el mundo real.OBJETIVO:Evaluar los resultados a corto plazo de la resección anterior baja laparoscópica con la participación de un cirujano colorrectal certificado.DISEÑO:Este fue un estudio de cohorte retrospectivo que utilizó una base de datos nacional japonesa.AJUSTE:Este estudio se realizó como un proyecto para la Sociedad Japonesa de Cirugía Endoscópica y la Sociedad Japonesa de Cirugía Gastroenterológica.PACIENTES:este estudio incluyó a 41 741 pacientes incluidos en la base de datos clínica nacional que se sometieron a una resección anterior baja laparoscópica realizada por cirujanos certificados, no certificados y certificados específicamente colorrectales, según el Sistema de calificación de habilidades quirúrgicas endoscópicas de 2016 a 2018.PRINCIPALES MEDIDAS DE RESULTADO:La tasa de mortalidad operatoria y la tasa de fuga anastomótica fueron los resultados primarios.RESULTADOS:La mortalidad general a los 30 días y la mortalidad operatoria fueron del 0,2 % y el 0,3 %, respectivamente, sin diferencias significativas entre los grupos de todos los tipos de cirujanos certificados y no certificados. La tasa global de fuga anastomótica fue del 9,3 %, con una diferencia significativa entre los dos grupos. Los grupos con certificación colorrectal y estomacal tuvieron una mortalidad a los 30 días y una mortalidad operatoria más bajas que los grupos con certificación biliar y sin certificación. La tasa de fuga anastomótica fue la más baja en el grupo certificado colorrectal. Con base en un análisis de regresión logística utilizando el modelo ajustado por riesgo, la mortalidad operatoria fue significativamente más alta en el grupo con certificación biliar que en el grupo con certificación colorrectal. Además, la tasa de fuga anastomótica fue significativamente más baja en el grupo con certificación colorrectal que en los grupos con certificación estomacal y sin certificación.LIMITACIONES:Este estudio fue retrospectivo y existía la posibilidad de diferentes definiciones de fuga anastomótica debido al uso de una base de datos nacional.CONCLUSIONES:La participación de un cirujano certificado en video específico colorrectal puede disminuir el riesgo de mortalidad operatoria y fuga anastomótica para la resección anterior baja laparoscópica. (Traducción-Dr. Mauricio Santamaria ).

Risk Assessment of Liver Transplantation After Kasai Portoenterostomy in Children and Adults.

INTRODUCTION: Reports of liver transplantation (LT) after Kasai portoenterostomy (KPE) in adult patients with biliary atresia are scarce. The aim of this study was to evaluate the outcomes and investigate the risk factors of LT after KPE in both pediatric and adult patients. METHODS: We retrospectively reviewed a prospective database of patients with biliary atresia who underwent LT after KPE. Eighty-nine consecutive patients were included, and risk factors for in-hospital mortality after LT were assessed. RESULTS: The median age of the patients was 2 y (range, 0-45 y). Forty-six patients (51.7%) had a history of upper abdominal surgery after KPE. The in-hospital mortality rate was 5.6% (5 patients). Of these, 80% of patients with mortality were aged ≥17 y, and all patients with mortality had a history of two or more upper abdominal surgeries. In the univariate and receiver operating characteristic curve analyses, age ≥17 y and the number of previous upper abdominal surgeries ≥2 were identified as possible risk factors. CONCLUSIONS: Our study suggests that older age and multiple previous upper abdominal surgeries are important risk factors for mortality after LT following KPE. We believe that these findings will serve as indications for safe LT in future patients.

A multicenter survey of effects and challenges of an 8K ultra-high-definition endoscopy system compared to existing endoscopy systems for endoscopic surgery.

INTRODUCTION: 8K ultra-high-definition (UHD) images enabling clearer recognition of anatomical structures could contribute to further development of surgical techniques and advanced applications in endoscopic surgery fields. This study aimed to clarify effects and challenges of endoscopic surgery with 8K UHD endoscopy compared to existing endoscopy systems. METHODS: In this multicenter, cross-sectional, questionnaire survey, data were collected from surgical participants who newly used and observed 8K UHD endoscopy in patients undergoing surgery from February 2020 to February 2021. Survey items included sense of presence, reality, depth perception, visibility of tissue, eyestrain, and degree of satisfaction for operators and observers, and weight, operability, focus adjustment, physical fatigue, eyestrain, and satisfaction for camera assistants. Participants rated each 8K UHD endoscopic surgery on a one-to-five scale (definitively inferior, relatively inferior, equivalent, relatively superior, definitively superior) compared to the existing endoscopy system of each facility. RESULTS: Overall, questionnaire responses from 139 participants assessing 8K UHD endoscopic surgery were collected from surgeries performed in 46 patients. Respective ratings of operators and observers included sense of presence: "superior or relatively superior", 97.8% and 91.5%; reality: "superior or relatively superior", 76.1% and 72.3%; and visibility of tissue: "superior or relatively superior", 93.5% and 87.2%. Weight was rated as "inferior or relatively inferior" by 73.9% of camera assistants and focus adjustment as "inferior" by 60.9% of them. CONCLUSIONS: 8K UHD endoscopic surgery enabled identification of surgical anatomies more clearly, provided a sense of presence and reality, and might improve educational effect. Technological development is expected to reduce the burden of camera assistants.

Surgical Experience Disparity Between Male and Female Surgeons in Japan.

Importance: Women are vastly underrepresented in surgical leadership and management in Japan. The lack of equal opportunities for surgical training is speculated to be the main reason for this disparity; however, this hypothesis has not been investigated thus far. Objective: To examine gender disparity in the number of surgical experiences among Japanese surgeons. Design, Setting, and Participants: This retrospective, multicenter cross-sectional study used data from the National Clinical Database, which contains more than 95% of all surgical procedures in Japan. Participants included male and female gastroenterological surgeons who performed appendectomy, cholecystectomy, right hemicolectomy, distal gastrectomy, low anterior resection, and pancreaticoduodenectomy between January 1, 2013, and December 31, 2017. Exposures: Differences in the number of surgical experiences between male and female surgeons. Main Outcomes and Measures: The primary outcomes were the total number of operations and number of operations per surgeon by gender and years of experience. Data were analyzed from March 18 to August 31, 2021. Results: Of 1 147 068 total operations, 83 354 (7.27%) were performed by female surgeons and 1 063 714 (92.73%) by male surgeons. Among the 6 operative procedures, the percentage of operations performed by female surgeons were the highest for appendectomy (n = 20 648 [9.83%]) and cholecystectomy (n = 41 271 [7.89%]) and lowest for low anterior resection (n = 4507 [4.57%]) and pancreaticoduodenectomy (n = 1329 [2.64%]). Regarding the number of operations per surgeon, female surgeons had fewer surgical experiences for all 6 types of operations in all years after registration, except for appendectomy and cholecystectomy in the first 2 years after medical registration. The largest gender disparity for each surgical procedure was 3.17 times more procedures for male vs female surgeons for appendectomy (at 15 years after medical registration), 4.93 times for cholecystectomy (at 30-39 years), 3.65 times for right hemicolectomy (at 30-39 years), 3.02 times for distal gastrectomy (at 27-29 years), 6.75 times for low anterior resection (at 27-29 years), and 22.2 times for pancreaticoduodenectomy (at 30-39 years). Conclusions and Relevance: This cross-sectional study found that female surgeons had less surgical experience than male surgeons in Japan, and this gap tended to widen with an increase in years of experience, especially for medium- and high-difficulty operations. Gender disparity in surgical experience needs to be eliminated, so that female surgeons can advance to leadership positions.

Cost of postoperative complications of lower anterior resection for rectal cancer: a nationwide registry study of 15,187 patients.

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.

Safe implementation of robotic gastrectomy for gastric cancer under the requirements for universal health insurance coverage: a retrospective cohort study using a nationwide registry database in Japan.

BACKGROUND: Robotic gastrectomy (RG) has increased since being covered by universal health insurance in 2018. However, to ensure patient safety the operating surgeon and facility must meet specific requirements. We aimed to determine whether RG has been safely implemented under the requirements for universal health insurance in Japan. METHODS: Data of consecutive patients with primary gastric cancer who underwent minimally invasive total or distal gastrectomy-performed by a surgeon certified by the Japan Society for Endoscopic Surgery (JSES) endoscopic surgical skill qualification system (ESSQS) between October 2018 and December 2019-were extracted from the gastrointestinal surgery section of the National Clinical Database (NCD). The primary outcome was morbidity over Clavien-Dindo classification grade IIIa. Patient demographics and hospital volume were matched between RG and laparoscopic gastrectomy (LG) using propensity score-matched analysis (PSM), and the short-term outcomes of RG and LG were compared. RESULTS: After PSM, 2671 patients who underwent RG and 2671 who underwent LG were retrieved (from a total of 9881), and the standardized difference of all the confounding factors reduced to 0.07 or less. Morbidity rates did not differ between the RG and LG patients (RG, 4.9% vs. LG, 3.9%; p = 0.084). No difference was observed in 30-day mortality (RG, 0.2% vs. LG, 0.1%; p = 0.754). The reoperation rate was greater following RG (RG, 2.2% vs. LG, 1.2%; p = 0.004); however, the duration of postoperative hospitalization was shorter (RG, 10 [8-13] days vs. LG, 11 [9-14] days; p < 0.001). CONCLUSIONS: Insurance-covered RG has been safely implemented nationwide.

Intraoperative Perfusion Assessment in Enhanced Reality Using Quantitative Optical Imaging: An Experimental Study in a Pancreatic Partial Ischemia Model.

To reduce the risk of pancreatic fistula after pancreatectomy, a satisfactory blood flow at the pancreatic stump is considered crucial. Our group has developed and validated a real-time computational imaging analysis of tissue perfusion, using fluorescence imaging, the fluorescence-based enhanced reality (FLER). Hyperspectral imaging (HSI) is another emerging technology, which provides tissue-specific spectral signatures, allowing for perfusion quantification. Both imaging modalities were employed to estimate perfusion in a porcine model of partial pancreatic ischemia. Perfusion quantification was assessed using the metrics of both imaging modalities (slope of the time to reach maximum fluorescence intensity and tissue oxygen saturation (StO2), for FLER and HSI, respectively). We found that the HSI-StO2 and the FLER slope were statistically correlated using the Spearman analysis (R = 0.697; p = 0.013). Local capillary lactate values were statistically correlated to the HSI-StO2 and to the FLER slope (R = -0.88; p < 0.001 and R = -0.608; p = 0.0074). HSI-based and FLER-based lactate prediction models had statistically similar predictive abilities (p = 0.112). Both modalities are promising to assess real-time pancreatic perfusion. Clinical translation in human pancreatic surgery is currently underway.

Assessment of lymphatic flow based on the sentinel node concept in early gastric adenocarcinoma that satisfies expanded endoscopic resection criteria.

BACKGROUND: Even though indications for endoscopic resection (ER) in early gastric cancer are determined based on the potential risk of lymph node metastasis, the criteria for ER remain controversial. Sentinel node (SN) mapping for early gastric cancer can help determine regional lymphatic flow patterns. The aim of this study was to assess lymphatic flow according to the SN concept in patients with early gastric cancer, especially those who satisfy the expanded criteria for ER. METHODS: We retrospectively enrolled 301 patients diagnosed with pT1 adenocarcinoma who had undergone gastrectomy with SN mapping and had no lymphovascular invasion. Patients were categorized into six groups based on oncological assessment. We analyzed lymphatic flow, including the number of identified SN and SN basin, and the rate of SN metastasis in each group. RESULTS: Of the 301 patients, 128 (42.5%) met the criteria for ER, with 18 in the absolute group and 110 in the expanded group; 173 (57.5%) were assigned to the surgical group. SN metastasis rate tended to be higher in surgical group patients than in ER criteria patients. In the expanded criteria group, the sub-group of patients with intramucosal, undifferentiated adenocarcinoma measuring 20 mm or less had a significantly greater number of identified SNs (p = 0.013) and SN basins (p = 0.032). Furthermore, SN metastasis was observed only in this group. CONCLUSIONS: Patients with intramucosal, nonulcerated, undifferentiated adenocarcinoma measuring 20 mm or less could develop a lymphatic network. For these patients, careful follow-up is required after ER.

Salivary metabolomics with alternative decision tree-based machine learning methods for breast cancer discrimination.

PURPOSE: The aim of this study is to explore new salivary biomarkers to discriminate breast cancer patients from healthy controls. METHODS: Saliva samples were collected after 9 h fasting and were immediately stored at - 80 °C. Capillary electrophoresis and liquid chromatography with mass spectrometry were used to quantify hundreds of hydrophilic metabolites. Conventional statistical analyses and artificial intelligence-based methods were used to assess the discrimination abilities of the quantified metabolites. A multiple logistic regression (MLR) model and an alternative decision tree (ADTree)-based machine learning method were used. The generalization abilities of these mathematical models were validated in various computational tests, such as cross-validation and resampling methods. RESULTS: One hundred sixty-six unstimulated saliva samples were collected from 101 patients with invasive carcinoma of the breast (IC), 23 patients with ductal carcinoma in situ (DCIS), and 42 healthy controls (C). Of the 260 quantified metabolites, polyamines were significantly elevated in the saliva of patients with breast cancer. Spermine showed the highest area under the receiver operating characteristic curves [0.766; 95% confidence interval (CI) 0.671-0.840, P < 0.0001] to discriminate IC from C. In addition to spermine, polyamines and their acetylated forms were elevated in IC only. Two hundred each of two-fold, five-fold, and ten-fold cross-validation using different random values were conducted and the MLR model had slightly better accuracy. The ADTree with an ensemble approach showed higher accuracy (0.912; 95% CI 0.838-0.961, P < 0.0001). These prediction models also included spermine as a predictive factor. CONCLUSIONS: These data indicated that combinations of salivary metabolomics with the ADTree-based machine learning methods show potential for non-invasive screening of breast cancer.

[The 2nd Japan Public-Private Dialogue Forum-A Multi-Stakeholder Dialogue on Universal Health Coverage for Cancer in Asia-Seeking an Approach to Asia Health and Wellbeing Initiative].

On 5 September 2018 the UICC-Asia Regional Office(UICC-ARO)convened the second Japan Public-Private Dialogue Forum at the House of Councilors Members' Building as a follow-up to the previous meeting held at United Nations University in Tokyo in April 2018. Senior representatives of government, academia and industry met to discuss the progress made since April, noting the significance of the Japanese government having included specific reference to cancer in its revised basic policy on the Asia Health and Wellbeing Initiative, which was adopted in July 2018. The meeting provided an opportunity for all stakeholders to discuss ways forward for improving access to cancer care, with the WHO Cancer Report and other global initiatives in mind.

Assessment of the Safety of the New Hybrid Pencil Type Energy (NP) Device Used Close to the Recurrent Laryngeal Nerve in a Porcine Model: Comparison With a Conventional Electrosurgical Knife.

BACKGROUND: Recurrent laryngeal nerve (RLN) paralysis is mainly associated with esophagectomy, and it may result in not only other morbidities, such as aspiration pneumonia, but also in long-term issues. Therefore, an approach to prevent RLN paralysis is necessary. The present study was designed to determine the technical usability of the new hybrid pencil type energy (NP) device developed by Olympus Corporation (Tokyo, Japan) and compare it with a conventional electrosurgical knife (EK) for resection around the RLN lymph nodes. METHODS: This nonsurvival (acute) study included 10 pigs (20 RLNs) and investigated the threshold for thermal RLN damage with the NP device and a conventional EK. To obtain basic information for our study, a preliminary experiment for heat spread was performed. RESULTS: When using the EK device, the amplitude value disappeared at a distance of 1 mm from the RLN, but when using the NP device, the amplitude value was maintained up to a distance of 0.5 mm. There were significant differences at distances of 0 mm, 0.5 mm, and 1 mm between the NP and EK devices. Furthermore, heat spread was lower with the NP device than with the EK device. CONCLUSIONS: The new energy device developed by Olympus Corporation was found to be technically safe for resection of the RLN lymph nodes in a porcine model. To the best of our knowledge, this is the first study to demonstrate the potential advantages of using this new energy device in a clinical aspect.

Effectiveness of Antiemetic Regimens for Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: A Systematic Review and Network Meta-Analysis.

BACKGROUND: It is important to control chemotherapy-induced nausea and vomiting (CINV) to maintain dose intensity and patients' quality of life. The National Comprehensive Cancer Network guidelines suggest combination therapy of antiemetic agents. The growing number of antiemetic regimens, and in particular the growing use of regimens containing antagonists to the Nk-1 receptor (NK1RAs) and the antipsychotic drug olanzapine (OLZ), call for the re-evaluation of the optimal regimen for CINV. This study assessed the efficacy and safety of antiemetic regimens for highly emetogenic chemotherapy, using Bayesian network meta-analysis. METHODS: Randomized trials that compared different antiemetic regimens were included. We strictly followed Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. The main outcomes were the odds ratio (OR) for overall complete response (absence of vomiting). We conducted network meta-analysis within a Bayesian model to combine the direct and indirect evidence. Safety was assessed from the trial description. All statistical tests were two-sided. RESULTS: We systematically reviewed 27 randomized control trials (13,356 participants), which compared 12 different antiemetic regimens: serotonin-3 receptor antagonist (5HT3), 5HT3 + dexamethasone (Dex), palonosetron (PAL), PAL + Dex, PAL at 0.75 mg (PAL0.75), PAL0.75 + Dex, NK1RA + 5HT3 + Dex, NK1RA + PAL + Dex, an oral combination of netupitant and palonosetron (NEPA) + Dex, OLZ + 5HT3 + Dex, OLZ + PAL + Dex, and OLZ + NK1RA + 5HT3 + Dex. An NK1RA + 5HT3 + Dex regimen and an NK1RA + palonosetron + Dex regimen gave a higher complete response (CR) rate than the reference regimen, 5HT3 + Dex (OR, 1.75; 95% credibility interval [95% CrI], 1.56-1.97, and OR, 2.25; 95% CrI, 1.66-3.03, respectively). A regimen containing NEPA was more effective in producing CR than conventional regimens without NEPA or olanzapine. Further analysis, based on the surface under the cumulative ranking probability curve, indicated that olanzapine-containing regimens were the most effective in producing CR. CONCLUSION: Our meta-analysis supports the conclusion that olanzapine-containing regimens are the most effective for CINV of highly emetogenic chemotherapy. We confirmed that NK1RA + PAL + Dex is the most effective of conventional regimens. Substituting olanzapine for an Nk-1 receptor antagonist may offer a less costly and more effective alternative for patients. IMPLICATIONS FOR PRACTICE: Nausea and vomiting during chemotherapy often pose difficulties for patients and doctors, making it hard to continue the proper therapy and to maintain the quality of life. This article gives insights into the optimal choice of medicine to treat nausea during chemotherapy. The findings reported here provide readers with a robust efficacy ranking of antinausea medicine, which can be used as a reference for the best possible treatment. Furthermore, the 70% less costly drug, olanzapine, is suggested to be equally effective to aprepitant in reducing nausea and vomiting. The possibility of offering a cost-effective treatment to a wider range of the population is discussed.

Treatment selection for esophageal cancer: evaluation from a nationwide database.

BACKGROUND: Most elderly patients poorly tolerate the standard treatment for esophageal cancer; however, little information is available regarding the appropriateness of non-standard esophageal cancer treatments for those patients. This study aims to analyze the treatment costs and completion rates of patients undergoing a real-world treatment for esophageal cancer to elucidate the treatment selection and its quality. MATERIALS AND METHODS: We analyzed treatment costs and completion rates for patients with esophageal cancer and analyzed these data relative to patient age and center volumes. Patients with esophageal cancer [UICC, TMN, Clinical stage II/III (excluding T4)] who were diagnosed in 2013 were analyzed. Patients were classified into five groups defined as follows: surgical therapy, chemotherapy, concurrent chemoradiotherapy (CCRT), modified concurrent chemoradiotherapy (mCRT), and radiotherapy (RT). RESULTS: Mean and median age of patients who received surgery and CCRT were comparable; however, patients who underwent mCRT and RT tended to be older. Medical costs associated with surgery were higher than costs associated with other non-surgical treatments. Cost and completion rate of chemoradiotherapy did not differ between CCRT and mCRT; however, both had higher completion rates compared to that of RT. Surgical expenses tended to be the highest in low-volume centers and the lowest in high-volume centers. CONCLUSION: Treatment of esophageal cancer at high-volume centers seems well balanced compared with medium- to low-volume centers. mCRT was widely performed and comparable in medical cost to CCRT, although additional clinical impacts were unclear.

Clinical utility of the Revised Cardiac Risk Index in non-cardiac surgery for elderly patients: a prospective cohort study.

PURPOSE: We investigated the association between the Revised Cardiac Risk Index (RCRI) and postoperative outcomes in patients undergoing non-cardiac surgery. METHODS: The predictive value of the RCRI for the risk of perioperative complications, length of hospital stay and hospital cost were evaluated from a prospective cohort of 119 patients aged ≥65 years undergoing elective major digestive, breast or vascular surgery. RESULTS: Comparing three groups RCRI 0, 1 and ≥2, the morbidity rates were 0, 30 and 68 %; the median length of hospitalization was 5, 14 and 28 days; and the median cost was 665,000, 1,480,000 and 2,160,000 yen, respectively. The mortality rate was 0 % in all groups. The RCRI 0 group included only non-high-risk (breast and peripheral vascular) surgeries. In addition, comparing the two groups by excluding non-high-risk surgeries (RCRI 1 and ≥2), the median morbidity rates were 31 and 67 %, the median length of hospitalization was 15 and 28 days, and the median cost was 1,550,000 and 2,130,000 yen, respectively. The RCRI score was the only independent predictor of the perioperative complications. CONCLUSIONS: In the case of non-cardiac surgery, the RCRI can identify patients at higher risk of perioperative complications, a prolonged hospital stay and higher hospital cost.

Risk model for right hemicolectomy based on 19,070 Japanese patients in the National Clinical Database.

BACKGROUND: Right hemicolectomy is a very common procedure throughout the world, although this procedure is known to carry substantial surgical risks. The present study aimed to develop a risk model for right hemicolectomy outcomes based on a nationwide internet-based database. METHODS: The National Clinical Database (NCD) collected records on over 1,200,000 surgical cases from 3,500 Japanese hospitals in 2011. After data cleanup, we analyzed 19,070 records regarding right hemicolectomy performed between January 2011 and December 2011. RESULTS: The 30-day and operative mortality rates were 1.1 and 2.3 %, respectively. The 30-day mortality rates of patients after elective and emergency surgery were 0.7 and 6.0 %, respectively (P < 0.001). The odds ratios of preoperative risk factors for 30-day mortality were: platelet <50,000/µl, 5.6; ASA grade 4 or 5, 4.0; acute renal failure, 3.2; total bilirubin over 3 mg/dl, 3.1; and AST over 35 U/l, 3.1. The odds ratios for operative mortality were: previous peripheral vascular disease, 3.1; cancer with multiple metastases, 3.1; and ASA grade 4 or 5, 2.9. Sixteen and 26 factors were selected for risk models of 30-day and operative mortality, respectively. The c-index of both models was 0.903 [95 % confidence interval (CI) 0.877-0.928; P < 0.001] and 0.891 (95 % CI 0.873-0.908; P < 0.001), respectively. CONCLUSION: We performed the first reported risk stratification study for right hemicolectomy based on a nationwide internet-based database. The outcomes of right hemicolectomy in the nationwide population were satisfactory. The risk models developed in this study will help to improve the quality of surgical practice.

Experience of risk-reducing salpingo-oophorectomy for a BRCA1 mutation carrier and establishment of a system performing a preventive surgery for hereditary breast and ovarian cancer syndrome in Japan: our challenges for the future.

BACKGROUND: Risk-reducing salpingo-oophorectomy is currently regarded as the most certain primary method for preventing ovarian cancer among BRCA1/2 mutation carriers with hereditary breast and ovarian cancer syndrome. However, risk-reducing salpingo-oophorectomy has rarely been performed in Japan. METHODS: We developed the first system in Japan for performing risk-reducing salpingo-oophorectomy for BRCA1/2 mutation carriers at our university hospital in 2008. RESULTS: The indication for risk-reducing salpingo-oophorectomy for patients with hereditary breast/ovarian cancer syndrome is currently limited in Japan. This situation may be because of the limited number of genetic counseling units, the limited number of facilities that can perform BRCA1/2 genetic testing and the fact that prophylactic surgery is not covered by health insurance in Japan. CONCLUSIONS: Recent treatment guidelines for breast cancer in Japan recommended risk-reducing salpingo-oophorectomy for BRCA1/2 mutation carriers. Risk-reducing salpingo-oophorectomy should be performed in the framework of the standard therapeutic modality for BRCA1/2 mutation carriers in the near future.