Background: Patients with malignant brain tumors are often accompanied by progressive loss of consciousness, aphasia, and paralysis, and often miss the time to make decisions on their own. Methods: In an acute neurosurgical unit, a multidisciplinary conference was held to support decision-making, and a brain tumor-specific advance care planning (ACP) leaflet was created and operated. The attainment rate of the five steps of ACP and the number of times the ACP process was repeated during hospitalization were evaluated for 79 inpatients before and after the introduction of the leaflet. Results: Forty-eight patients received decision-making support with the leaflet, while 31 did not. The rate of achievement of the discussion (38.7% vs 89.6%, p<0.001) and writing down (6.5% vs 33.3%, p=0.006) in ACP significantly increased after the introduction of the leaflet. Conclusion: The newly developed brain tumor-specific ACP leaflet was useful in promoting ACP for patients with brain tumors and providing decision support. In addition, a multidisciplinary ACP support framework for brain tumor patients has been established through ACP conferences.

Although the recent revision of the ministerial ordinance on Good Post-marketing Study Practice (GPSP) included the utilization of medical information databases for post-marketing surveillance, there has been limited research on the validity of diagnosis codes and other outcome definitions in Japanese databases such as administrative claims (“receipt”) database. This task force proposed how to conduct good validations studies, based on the narrative review on around 100 published papers around the world. The established check list consists of ： (ⅰ) understanding the type of the database (e.g. administrative claims data, electronic health records, disease registry) ； (ii) understanding the setting of the validation study (e.g. “population-based” or not) ； (iii) defining the study outcome ； (iv) determining the way of linkage between databases ； (v) defining the gold standard ； (vi) selecting the sampling method (e.g. using the information of all patients in the database or a hospital, random sampling from all patients, random sampling from patients satisfying the outcome definition, random sampling from patients satisfying and not satisfying the outcome definition, “all possible cases” method) and sample size ； (vii) calculating the measures of validity (e.g. sensitivity, specificity, positive predictive value, negative predictive value) ； and (viii) discussing how to use the result for future studies. In current Japan, where the linkage between databases is logistically and legally difficult, most validation studies would to be conducted on a hospital basis. In such a situation, detailed description of hospital and patient characteristics is important to discuss the generalizability of the validation study result to the entire database. This report is expected to encourage and help to conduct appropriate validation studies.

BACKGROUND: Both endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) and tumor ablation using ethanol are very common procedures, and the utility of these therapies has already been reported in prominent journals. However, their effectiveness appears temporary and insufficient, especially EUS-CPN. We therefore have to consider new reagents for improving the results. The present study examined the best concentration of ethanol and povidone iodine mixed with atelocollagen for more effective therapies. METHODS: The effects of the new reagents were confirmed in three live pigs. At first, we injected three kinds of reagents (including indigo carmine) in three separate areas of para-aortic tissue under EUS guidance in one pig. At more than 4 hours after injection, we checked ethanol injection sites after dissection. In next study, we performed EUS-guided injection of a total of six kinds of reagents (two kinds of ethanol, three kinds of povidone iodine, and control atelocollagen) into the livers of two living pigs. After 2 weeks, we examined tissue damage to the liver in the two pigs. RESULTS: The 75% ethanol (absolute ethanol 3.75 mL + 1% atelocollagen 1.25 mL + a very small amount of indigo carmine) was seen like blue gel, and still remained in the para-aortic tissue. Brownish areas of povidone iodine mixed with 3% atelocollagen exhibited clear, regular borders with greatly reduced infiltration into surrounding tissue compared to others. CONCLUSION: We concluded that 75% ethanol mixed with 1% atelocollagen appears optimal for EUS-CPN. Povidone iodine mixed with 3% atelocollagen may be suitable for small tumor ablation therapy.
Celiac Plexus* ; Endoscopic Ultrasound-Guided Fine Needle Aspiration ; Endosonography ; Ethanol ; Indicators and Reagents ; Indigo Carmine ; Liver ; Povidone-Iodine ; Swine

Background: Because generic medicines reduce the financial burden on patients and medical insurance providers, they become more popular year after year.  However, there are still few reports that analyze the efficacy and safety of generic medicines, especially in terms of their characteristics and side effects.
Methods: Paclitaxel is an antineoplastic frequently used with good results in the treatment of breast cancer, ovarian cancer, gastric cancer, and angiosarcoma, but fat solubility is high and various kinds of adverse events, such as myelosuppression and arthralgia, peripheral neuropathy, and alcohol hypersensitivity are known to develop.  We investigated the efficacy, characteristics, and the incidence of adverse events for the generic product of paclitaxel.
Results: Differences were found for the generic version in terms of the characteristics and preparation time.
Conclusion: The incidence of adverse events was not significant, suggesting that the generic version could be a reasonable substitute.