The Clinical Features of Late Postoperative Cholangitis After Hepaticojejunostomy Brought on by Conditions other than Cancer Recurrence.

PURPOSE: Postoperative cholangitis and anastomotic strictures (AS) are long-term complications of biliary-enteric anastomosis (BEA). METHODS: We retrospectively reviewed data of patients who underwent bile duct resection with or without hepatectomy and investigated the risk factors for postoperative cholangitis, benign AS, and incidence of Clavien-Dindo (C-D) >Grade III complications. RESULTS: Overall, data of 189 patients (115 men and 74 women) were retrospectively analyzed. The median patient age was 73 years. Thirty-five patients (18.5%) developed postoperative cholangitis, and 16 (8.4%) developed postoperative AS. Male sex and serious postoperative complications (C-D ≥ Grade III) were independent risk factors for cholangitis. The incidence of serious postoperative complications was 32.3%. Hypertension, preoperative biliary drainage, C-reactive protein-albumin ratio ≥.22, and bile duct resection with hepatectomy were potential risk factors for serious postoperative complications. CONCLUSIONS: The incidence rates of postoperative cholangitis and AS after BEA were 18.5% and 8.4%, respectively. Male sex and serious postoperative complications (C-D ≥ Grade III) were independent risk factors for postoperative cholangitis.

Evolving partnership: A National Center for Global Health and Medicine Resilient Training Model for clinical research professionals during the COVID-19 pandemic.

The clinical trial industry has encountered challenging circumstances in which the increasing number of trials outpaces the number of trial specialists. For instance, there has been an unprecedented demand for clinical trials following the Covid-19 pandemic, which has worsened the global shortage of qualified personnel. It is therefore imperative to produce more qualified clinical trial professionals. An adaptive and collaborative training model was implemented by the National Center for Global Health and Medicine through the Department of International Trials. This aimed at building capacity among health workers in developing countries and providing them with the skills to be able to conduct all phases of the clinical trial from protocol design to publication of results. It also seeks to foster collaboration and partnership between local health workers and international experts. Since 2016, we have implemented a Japan-led training program, and since 2020, the COVID-19 pandemic has ushered in a shift from a single Train-the-trainer model (ToT) to a mixed model, the Evolving Partnership Training (ePT). In this model, we applied four different methods: train-the-trainer, needs-oriented training, open symposiums, and advanced learning. The total number of training participants increased exponentially from a total of 41 between 2016-2020 to 2,810 in 2021. Our experience has proven that despite the constraint of the pandemic, the ePT is a viable approach compared to a single method for providing quality training and increasing the number of participants.

Knowledge, attitude, perception, and factors associated with the risk perception of COVID-19 among nursing college students in Japanese universities: A cross-sectional study.

Background and Aim: The spread of coronavirus disease 2019 (COVID-19) in the world has brought different attitudes and perceptions among social strata. Nursing students being future first-line healthcare workers are more at risk of being infected and exposed to various stressors from shared information. The objectives of this study were to evaluate the knowledge, attitude, and perception of COVID-19 among nursing students and to estimate predictors of their risk perception. Methods: We conducted an online survey among undergraduate nursing students at three selected Japanese Universities. Data on knowledge, attitude, and perception toward COVID-19 were collected using a structured questionnaire. We performed multiple logistic regression analyses to identify factors associated with the risk perception toward COVID-19 infection. Results: Of the 414 nursing students who participated in the study, 368 (90.4%) reported that the media including radio, television, internet, and/or social media were the main source of knowledge. Fever (96.1%) and dry cough (89.6%) were reported as the main symptoms. Regarding the attitude toward the treatment and preventive measures, almost 92.8% of participants recommended the use of vaccines. Being female appeared to be three times associated with the fear of getting infected (adjusted odds ratio [aOR]:3.03; 95% confidence interval [CI]: 1.21-7.58). Students who took part in extracurricular activities reported that they feared being infected with COVID-19 (aOR:2.62; 95% CI:1.33-5.16). Other factors did not show an association. Conclusion: Knowledge and attitude of nursing students toward COVID-19 were accurate for the majority of them, with the main source of information being the media. Practicing extracurricular activities and being female were associated with the fear of the disease. Efficient and controlled communication is needed during widespread disease outbreaks.

Possibility of Neoadjuvant Treatment for Radiologically Judged Resectable Pancreatic Cancer.

Survival remains poor even after resection of pancreatic cancer and the postoperative recurrence rate is extremely high. Thus, neoadjuvant treatment may improve outcomes for resectable pancreatic cancer (RPC). This study evaluated the efficacy of neoadjuvant therapy for radiologically judged RPC. A prospectively maintained institutional database was reviewed to identify patients who underwent potentially curative resection of radiologically judged RPC. Patient characteristics and intermediate-term outcomes were compared between groups that received neoadjuvant treatment or upfront surgery (UFS). We identified 353 eligible patients, including 55 patients who received neoadjuvant chemoradiotherapy (CRT group), 53 patients who received neoadjuvant gemcitabine plus nab-paclitaxel (GnP group), and 245 patients who underwent UFS (UFS group). The cumulative rates of pancreatic cancer recurrence at 2 years after pancreatic surgery were 49.5% in the UFS, 48.1% in the CRT group, and 52.7% in the GnP group. The recurrence rate tended to be improved after neoadjuvant treatment, although the difference was not significant at this follow-up point. While the clinical TNM classifications were noticeably different from the final pathological findings, the clinical and pathological TNM classifications were more similar in the groups that underwent neoadjuvant treatment. Neoadjuvant treatment can help identify good surgical candidates and avoid unnecessary laparotomy. Our results also suggest that neoadjuvant therapy might help improve the preoperative diagnostic accuracy for patients with RPC.

Proposal for the revision of guidelines for clinical trials of vaccines to prevent infectious diseases in Japan.

The development of vaccines against infectious diseases requires a different approach from that of therapeutics, because vaccines are inoculated into healthy individuals and have a preventive effect by activating the immunity of the inoculated human. In Japan, "The Guideline for Clinical Trials of Vaccines for the Prevention of Infectious Diseases" was published in 2010 before changes occurred in the vaccine development environment in Japan, such as the introductions of foreign vaccines and simultaneous global development. This study aimed to identify current challenges in vaccine development through a questionnaire-based survey of pharmaceutical companies in Japan and by comparing the domestic and international guidelines and surveying review reports of 35 vaccines approved in Japan between April 2010 and December 2020. Identified challenges included the requirement for protective efficacy trials, efficacy evaluation of combination vaccines, development of multiregional and foreign clinical trials, and immunization of older adults and immunocompromised patients. We propose that new vaccines against infectious diseases should be evaluated for the protective efficacy, preferably through multiregional clinical trials. Additionally, differences in the incidence of infectious diseases or in epidemic virus strains between regions may affect the trials, when multiregional clinical trials are conducted, but immunogenicity-based studies can be conducted if a correlation between protective efficacy and immunogenicity has been established. We suggest that licensed combination vaccines can be used as comparators when an antigen is added to a licensed combination vaccine. We also proposed that the efficacy of a vaccine in non-major subjects, such as older adults or immunocompromised patients could be evaluated by comparing immunogenicity in major subjects with the confirmed protective effects of the vaccine. It is expected that these revisions will lead to the rapid advancement of vaccine development, which should contribute to the improvement of public health.

Boosting multiregional clinical trials (MRCT) in Asia through the establishment of the Japan-led network for clinical research, the ARO alliance for ASEAN & East Asia (ARISE).

There is an increasing demand for clinical research, and this demand has particularly increased during the novel coronavirus infection (COVID-19) pandemic. In the light of these events, fostering international cooperation has become essential. The ARO Alliance for ASEAN & East Asia (ARISE) is a Japan-led international network for clinical research in Asia that was established to encourage and facilitate multiregional clinical trials. The Department of International Trials of the National Center for Global Health and Medicine (NCGM) launched ARISE in December 2021 to pursue efficacious, high-quality clinical research and ensure rapid responses to health emergencies, with the timely provision of new medicinal products to patients in Asia.

Reconsideration of indications for third hepatectomy for colorectal liver metastases.

BACKGROUND: It is unclear which patients with recurrence after a second hepatectomy will benefit from a third hepatectomy. METHODS: Patients who underwent hepatectomy for colorectal liver metastasis (CRLM) between April 2005 and July 2021 were included. Factors affecting recurrence after each hepatectomy were analyzed. RESULTS: Sixty-four of the 167 patients who had recurrence after the first hepatectomy underwent a second hepatectomy. Then, 46 patients had recurrence and 18 patients did not have recurrence after the second hepatectomy. Sixteen patients who underwent a third hepatectomy had better overall survival (OS) than those who did not (52 vs. 31 months, p = 0.043). However, the multivariate analysis demonstrated that only tumor size (>5 cm) during the second hepatectomy (p = 0.022) and carbohydrate antigen 19-9 (CA 19-9) level (>50 U/ml) (p = 0.041) at recurrence after the second hepatectomy were poor prognostic factors for OS. CONCLUSION: While a third hepatectomy can be performed if it is technically and oncologically appropriate, tumor size >5 cm and CA 19-9 >50 U/ml should be considered in terms of long-term outcomes before proceeding to surgery.

Clinicopathological Features and Surgical Outcomes of Small Bowel Metastasis from Renal Cell Carcinoma.

Small bowel metastasis from renal cell carcinoma (RCC) is rare, and its clinicopathological characteristics are unclear; thus, we revisited the concept of this tumor and reviewed its diagnostic and treatment modalities. We filtered MEDLINE searches of articles published in English between 1950 and 2019, and identified 100 patients who had undergone treatment, including 1 patient from our clinic. We extracted patient characteristics, treatment, and prognostic data, resulting in clinicopathological data on 100 patients (83 men, 17 women). Mean age was 63 years (range, 16-86 years). Tumor sites were duodenum, jejunum, ileum, and multiple sites in 30, 37, 25, and 7 patients, respectively. The 1-, 3-, and 5-year overall survival rates after diagnosis were 53.0%, 36.0%, and 36.0%. Curative resection patients showed 62.1% 5-year survival after surgery, vs. 27.5% in noncurative surgical management cases. Good prognoses can be expected if these tumors are identified early for complete removal. Surgery is the only curative option. To determine the best management strategy and improve prognostic accuracy, we continue to collect and analyze epidemiological and pathological data. Although this condition is rare, surgery should be considered if curative resection is expected. Prognosis after curative resection is not poor, but recurrence is not unlikely.

The efficacy and adverse effects of favipiravir on patients with COVID-19: A systematic review and meta-analysis of published clinical trials and observational studies.

OBJECTIVES: This study aimed to evaluate the efficacy and adverse events of favipiravir in patients with COVID-19. METHODS: Our protocol was registered on PROSPERO (CRD42020206305). Fourteen databases were searched until February 8th, 2021. An update search for new RCTs was done on March 2nd, 2022. Meta-analysis was done for randomized controlled trials (RCTs) and non-RCTs. RESULTS: Overall, 157 studies (24 RCTs, 1 non-RCT, 21 observational studies, 2 case series, and 106 case reports) were included. On hospitalized patients, in comparison to standard of care, favipiravir showed a higher rate of viral clearance at day 5 (RR = 1.60, p = 0.02), defervescence at day 3-4 (RR = 1.99, p <0.01), chest radiological improvement (RR = 1.33, p <0.01), hospital discharge at day 10-11 (RR = 1.19, p <0.01), and shorter clinical improvement time (MD = -1.18, p = 0.05). Regarding adverse events, favipiravir groups had higher rates of hyperuricemia (RR = 9.42, p <0.01), increased alanine aminotransferase (RR = 1.35, p <0.01) but lower rates of nausea (RR = 0.42, p <0.01) and vomiting (R R= 0.19, p=0.02). There were no differences regarding mortality (RR=1.19, p=0.32), and increased aspartate aminotransferase (RR = 1.11, p = 0.25). On nonhospitalized patients, no significant differences were reported. CONCLUSIONS: Adding favipiravir to the standard of care provides better outcomes for hospitalized patients with COVID-19. Pregnant, lactating women, and patients with a history of hyperuricemia should avoid using favipiravir.

Proposal for the revision of the guidelines for Non-clinical studies of vaccines for the prevention of infectious diseases in Japan.

The efficacy and safety of vaccines for the prevention of infectious diseases are mostly evaluated based on the induction of an immune response against antigens, and do not necessarily depend on the dose administered. Therefore, there are some specific aspects that need to be considered in the development of vaccines and have been described in "The Guidelines for the non-clinical studies of vaccines for the prevention of infectious disease" in Japan. Recent changes in the vaccine development field, such as the introduction of vaccines developed overseas in Japan and vaccine development on a global scale have increased the need for revision of these guidelines. In this study, we identified the current challenges in the development of vaccines through comparison of Japanese and international guidelines. We conducted a questionnaire-based survey of pharmaceutical industries in Japan, and found issues related to non-clinical studies, such as the necessity of safety pharmacology studies and repeated-dose toxicity studies for each route of administration. We examined international guidelines on these issues as well as review reports by regulatory authorities, and determined that the results of repeated-dose toxicity studies can be used to decide whether safety pharmacology studies are required, and that studies to evaluate toxicity due to systemic effects may not be necessary for both intramuscular and subcutaneous administration. We propose revision of the guidelines for the non-clinical studies of vaccines in Japan taking international harmonizaion into account. We expected that the revised guidelines will promote smooth and rational vaccine development.

Association between nausea and vomiting of pregnancy and postpartum depression: the Japan Environment and Children's Study.

OBJECTIVE: Postpartum depression (PPD) is a global emotional distress that affects women and their offspring regardless of their culture. The association between nausea and vomiting of pregnancy (NVP) and PPD has been widely described only for the severe form of NVP. We aimed to assess the relationship between PPD and NVP with regards to its severity. METHODS: Data from the Japan Environment and Children's Study (JECS), a birth cohort study, were analyzed. PPD was assessed using the Edinburgh Postnatal Depression Scale (EPDS). Multiple logistic regression models were performed to assess the association between NVP and PPD. RESULTS: Out of the 80,396 women included in the study 14% had PPD. Among them 4,640 (42.1%) had mild NVP; 3,295 (29.9%) had moderate NVP whereas 1,481 (13.4%) had severe NVP. All forms of NVP were associated with PPD and the association gradually increased with the severity of NVP symptoms with odd ratio (OR): 1.26; 95% confidence interval (CI): 1.18-1.35 for mild, OR: 1.28; 95% CI: 1.19-1.38 for moderate and OR: 1.54; 95% CI: 1.42-1.68 for severe NVP. CONCLUSION: Japanese women with NVP were more susceptible to develop PPD and the more severe the NVP symptoms were, the greater the risk of PPD. Thus, close monitoring of NVP-affected women is recommended.

A proposal to modify the 8th edition of the UICC staging system for pancreatic adenocarcinoma.

PURPOSE: The aim of this study was to validate and improve the 8th edition of the Union for International Cancer Control (UICC) staging system for pancreatic ductal adenocarcinoma (PDAC). METHODS: Prognostic impact of the pathological tumor (pT) and lymph node (pN) stages between the 7th and 8th editions were compared using a single-center cohort of 311 patients who underwent curative pancreatic resection for PDAC. RESULTS: Applying the 7th edition T staging system resulted in a clustering of pT3 cases (92.3%) and failed to show significant prognostic differences between the three pT stages. However, applying the 8th edition T staging system yielded a more even distribution and resulted in an excellent prognostic separation between the pT stages based on decreases in median survival (month [pT1: 69.4, pT2: 27.6, pT3: 16.7], p=0.001). In pN staging system, the 8th edition provided more precise prognostication in median survival (month [pN0: 41.7, pN1: 25.6, pN2: 14.4], p<0.001). Moreover, in the 8th edition pT2 category, patients with portal vein invasion (PVI) showed significantly worse survival than those without PVI (median survival months [without PVI: 38.2, with PVI: 17.1], p<0.001). CONCLUSIONS: The 8th edition provides a more even distribution among stages and better stage discriminations compared to the 7th edition. The 8th edition pT2 category should be subdivided according to PVI status of the patient to allow for more precise patient prognostication.

Indications for pancreaticoduodenectomy affected postoperative outcomes in octogenarians.

AIMS: The safety and efficacy of pancreaticoduodenectomy (PD) in patients over the age of 80 years remain controversial. We aimed to examine post-PD outcomes and to determine the age limit for PD. METHODS: Patients were divided into two subgroups: the younger (<80 years) group and octogenarian (≥80 years) group. We retrospectively evaluated the clinical benefit of PD for periampullary diseases in the younger and octogenarian groups, focusing on short- and long-term outcomes. RESULTS: From March 2005 to December 2018, 586 consecutive surgically curable patients with diagnosed periampullary diseases were studied, among whom 122 (20.8%) were ≥80 years old. The general preoperative physical condition (G8 screening, instrumental activities of daily living, and Charlson comorbidity index) and nutritional status were significantly worse in the octogenarian group. However, there were no significant differences between the younger and octogenarian groups in postoperative severe complication rates (34% vs 36%) or perioperative mortality rates (1.5% vs 0.0%). We observed significantly poorer 3-, 5-, and 10-year overall survivals in the octogenarian group than in the younger group (P = .007). In the younger group, the main cause of death (89.6%) was cancer recurrence. However, only 60% of patients in the octogenarian group developed and died from cancer recurrence. Increased neutrophilic/lymphocyte ratio and elevated Controlling Nutritional Status score were associated with worse outcomes. CONCLUSIONS: It is important to carefully determine the indication for PD in octogenarian patients with periampullary diseases, although patient age over 80 years should not be a contraindication for PD.

l-Carnitine Improves Postoperative Liver Function in Hepatectomized Patients.

BACKGROUND AND AIMS: The effect of perioperative treatment with l-carnitine in hepatectomized patients is unclear. The objective of the current study is to evaluate the short-term outcomes after liver cancer surgery in patients treated with l-carnitine compared with nontreated patients. METHODS: Patients with primary liver malignancies scheduled to undergo a hepatectomy were randomly assigned to receive either perioperative treatment with l-carnitine (carnitine group) or usual intake (control group). The primary endpoint of this study was the short-term outcome after liver surgery. RESULTS: The study participants were randomly assigned into 2 groups: 106 patients in the control group and 102 patients in the perioperative l-carnitine supplementation group. The restoration of serum ammonia levels, prothrombin time, and peripheral neutrophil count at 3 days after the operation was significantly faster in the carnitine group than in the control group. Fewer patients in the carnitine group developed grade B posthepatic liver failure, according to the grading system of the International Study Group of Liver Surgery, than patients in the control group (20% vs 76%). The length of hospitalization was significantly shorter in patients in the carnitine group than in those in the control group. CONCLUSIONS: We found that perioperative treatment with l-carnitine was significantly better than ordinary treatment in reducing postoperative serum ammonia levels, suggesting that l-carnitine may serve as a pivotal regulator of liver injury and repair and result in shorter postoperative hospitalization (ClinicalTrials.gov trial registration no. NCT03021876).

Effect of Neoadjuvant Chemotherapy in Patients with Colorectal Cancer Liver Metastases.

BACKGROUND: This study was performed to evaluate the relationships between potential prognostic factors and post-surgery survival in patients with colorectal cancer liver metastasis (CRLM). In particular, this study investigated the value of neoadjuvant chemotherapy as an independent predictor of cancer-specific survival. METHODS: The study participants included 147 patients who underwent resection for CRLM. Demographics, treatments, and relationships between potential prognostic factors and the survival rate were analyzed using a prospective database. RESULTS: The overall 1-, 3- and 5-year cancer-specific survival rates for post-surgery CRLM patients were 94.3%, 71.2%, and 53.5%, respectively. Multivariate analysis revealed that a positive surgical margin and extrahepatic metastasis were independent negative prognostic factors. The administration of neoadjuvant chemotherapy prior to liver surgery did not significantly improve post-surgery outcomes of patients with CRLM. In a subgroup analysis, the time to recurrence in the remnant liver after hepatectomy for CRLM was significantly less in the neoadjuvant group than in the upfront surgery group. CONCLUSIONS: Neoadjuvant chemotherapy was not predictive of cancer-specific survival. The achievement of macroscopically and microscopically negative resection remains the main aim of surgery.

A Novel Physiobiological Parameter-Based Grading System for Resectable Pancreatic Cancer.

BACKGROUND: Preoperative methods to estimate disease-specific survival (DSS) for resectable pancreatic cancer are limited. OBJECTIVE: The aim of this study was to develop and validate a pretreatment physiobiological prognostic model in patients with radiologically resectable pancreatic cancer. METHODS: A retrospective review of a prospectively maintained institutional database was undertaken to identify patients who underwent potentially curative resection for radiologically resectable pancreatic cancer. Demographics, treatments, and relationships between the potential prognostic factors and survival rate were analyzed, and prognostic nomograms were established. RESULTS: We identified 240 patients who fulfilled our eligible criteria. The 1-, 3-, and 5-year DSS rates after surgery were 77.8, 40.9, and 31.3%, respectively. On multivariate analysis, increased neutrophil/lymphocyte ratio [hazard ratio (HR) 1.60, 95% confidence interval (CI) 1.17-2.17; p < 0.01], reduced Prognostic Nutritional Index (HR 2.08, 95% CI 1.68-3.20; p < 0.01), and elevated preoperative serum carbohydrate antigen 19-9 level (HR 2.12, 95% CI 1.55-2.88; p < 0.01) were associated with worse DSS. Although curative resection was the operative aim for all patients, 131 (54.6%) patients had recurrence within 12 months after curative resection of resectable pancreatic cancer. There was a significant correlation between recurrence pattern and physiobiological characteristics. CONCLUSION: We developed a new grading system for radiologically resectable pancreatic cancer. This system is simple and reliably predicts differences in survival after pancreatic resection.

Incidence and Risk Factors of Cholangitis after Hepaticojejunostomy.

BACKGROUND: After hepatobiliary-pancreatic surgery, hepaticojejunostomy cholangitis is a rare condition; the true incidence rate of postoperative cholangitis is unknown. Therefore, our study aimed to determine the incidence rate and timing of postoperative cholangitis after biliary-enteric anastomosis, and to evaluate risk factors and management strategies. METHODS: Our single-center retrospective study included 583 patients who had undergone biliary-enteric anastomosis for hepatobiliary-pancreatic diseases. Demographic and treatment data were extracted from the medical records, and the association between potential risk factors and the development of postoperative cholangitis evaluated using a prospectively collected database. RESULTS: Postoperative cholangitis developed in 45/583 patients (incidence rate, 7.7%), on average 18.3 ± 27.4 months (median = 6.9 months) after surgery. On multivariate analysis, the following factors were independently associated with postoperative cholangitis after biliary-enteric anastomosis: male sex, benign condition, and postoperative complication with a Clavien-Dindo classification grade > III. Among patients with postoperative cholangitis, a biliary stricture developed in 57.8% (26/45) of cases. Percutaneous balloon dilatation (73.1%) and endoscopic stenting (11.5%) were used as initial treatment of the stricture, with surgical revision being required in only 15.4% of cases of hepaticojejunostomy stricture. CONCLUSION: Biliary-enteric anastomotic cholangitis after hepaticojejunostomy is a distinct disease process. Although non-operative management of postoperative cholangitis is successful in many cases, further research is required to better understand patient- and physician-related factors that predispose patients to postoperative cholangitis.

Correlation between the skeletal muscle index and surgical outcomes of pancreaticoduodenectomy.

PURPOSES: Sarcopenia is known to be associated with a worse prognosis following abdominal operations; however, the relationship between sarcopenia and the outcomes of pancreaticoduodenectomy remains unclear. MATERIALS: We measured body composition parameters, including total abdominal muscle area, using preoperative staging computed tomography (CT), in patients undergoing pancreaticoduodenectomy for periampullary cancer. The incidence of sarcopenia among these patients was evaluated and multivariable analysis was performed to identify independent predictors of postoperative pancreatic fistula. RESULTS: We identified 335 consecutive patients who were eligible for the study. Patients with sarcopenia had significantly poorer 5-year survival rates than those without sarcopenia (32.4 vs. 51.6%, respectively, P = 0.009). Interestingly, the incidence of Grade B/C pancreatic fistula was significantly lower in the sarcopenia group than in the non-sarcopenia group. Multivariate analysis identified high body mass index and soft pancreatic texture as independent predictors of postoperative pancreatic fistula. CONCLUSION: Sarcopenia may have an independent prognostic effect on the survival of patients with periampullary cancer. Preoperative nutritional intervention and rehabilitation may improve the postoperative outcomes of pancreaticoduodenectomy for periampullary cancer.

Characterization of Prognostic Factors and the Efficacy of Adjuvant S-1 Chemotherapy in Patients with Post-surgery Extrahepatic Bile Duct Cancer.

BACKGROUND/AIM: There is no clear consensus on the type of adjuvant therapy that should be used for patients with extrahepatic bile duct cancer. PATIENTS AND METHODS: Two hundred and seventy-one patients that had undergone surgical resection for extrahepatic bile duct cancer composed the study cohort. Demographics, treatments, and relationships between the potential prognostic factors and survival rates were analyzed. RESULTS: The overall 3-year and 5-year survival rates for post-surgery extrahepatic bile duct cancer patients were 49.0% and 35.4%, respectively. Multivariate analysis revealed that regional lymph node metastasis was an independent negative prognostic factor. We observed a significant correlation between node-positive extrahepatic bile duct cancer and postoperative local recurrence, liver metastasis, peritoneal dissemination, and post-surgery lymph node metastasis. Adjuvant S-1 chemotherapy showed a favorable hazard ratio in patients with lymph node metastases or positive vascular invasion. CONCLUSION: We recommend the use of adjuvant S-1 therapy in patients with lymph node metastases or microvascular invasion.

Liver Function Assessment Using Technetium 99m-Galactosyl Single-Photon Emission Computed Tomography/CT Fusion Imaging: A Prospective Trial.

BACKGROUND: The prediction of postoperative liver function remains a largely subjective practice based on CT volumetric analysis. However, future liver volume after a hepatectomy is not the only factor that contributes to postoperative liver function and outcomes. STUDY DESIGN: In this prospective trial, 185 consecutive patients who underwent liver operations between 2014 and 2015 were studied. Volumetric and functional rates of remnant liver were measured using technetium 99m-galactosyl human serum albumin single-photon emission computed tomography/CT fusion imaging to evaluate post-hepatectomy remnant liver function. Remnant indocyanine green clearance rate using galactosyl (KGSA) (KGSA × functional rate) was used to predict future remnant liver function. Hepatectomy was considered safe for patients with remnant KGSA values ≥0.05, and the primary end point was to determine the accuracy and reliability of this criteria. The prediction of the 90-day major complication and mortality rates was assessed. RESULTS: Median hospital stay was 9 days and median ICU stay was 1 day, with only 1 in-hospital death (90-day mortality rate 0.5%). Overall morbidity rate evaluated according to the Clavien-Dindo classification was 9%. For post-hepatectomy liver failure definitions, the International Study Group of Liver Surgery definition was fulfilled in 14 patients (8%), with the majority being grade B (50%), compared with 2 patients (1%) fulfilling the "50-50" criteria, and 0 patients (0%) fulfilling the PeakBili >7 criteria. CONCLUSIONS: Results of this study showed that remnant KGSA provided information that allowed us to predict remnant liver function. This information will be important for surgeons when deciding on a treatment plan for patients with liver diseases. (ClinicalTrials.gov ID: NCT02013895).