Background/Aims: Covered self-expandable metallic stents (cSEMS) have become popular for endoscopic ultrasound-guided hepaticogastrostomy with transmural stenting (EUS-HGS). We compared the time to recurrent biliary obstruction (TRBO), complications, and reintervention rates between EUS-HGS using plastic stent (PS) and cSEMS in patients with unresectable malignancies at multicenter institutions in Japan. Methods: Patients with unresectable malignant biliary obstruction who underwent EUS-HGS between April 2015 and July 2020 at any of the six participating facilities were enrolled. Primary endpoint: TRBO; secondary endpoints: rate of complications other than recurrent biliary obstruction and technical success rate of reintervention were evaluated. Results: PS and cSEMS were used for EUS-HGS in 109 and 43 patients, respectively. The TRBO was significantly longer in the cSEMS group than in the PS group (646 vs. 202 days). Multivariate analysis identified two independent factors associated with a favorable TRBO: combined EUS-guided antegrade stenting with EUS-HGS and the use of cSEMS. No significant difference was observed in the rate of complications other than recurrent biliary obstruction between the two groups. The technical success rate of reintervention was 85.7% for PS and 100% for cSEMS (p=0.309). Conclusions cSEMS might be a better option for EUS-HGS in patients with unresectable malignancies, given the longer TRBO.

Purpose: Total or proximal gastrectomy of the upper-third early gastric cancer (u-EGC) often causes severe post-gastrectomy syndrome, suggesting that these procedures are extremely invasive for patients without pathologically positive lymph node (LN) metastasis. This study aimed to evaluate the clinical applicability of a stomach function-preserving surgery, local resection (LR), with prophylactic left gastric artery (LGA)-basin dissection (LGA-BD). Materials and Methods: The data of patients with u-EGC (pathologically diagnosed as T1) were retrospectively analyzed. Total gastrectomy was performed in 30 patients, proximal gastrectomy in 45, and subtotal gastrectomy in 6; the LN status was evaluated assuming that the patients had already underwent LR + LGA-BD. This procedure was considered feasible in patients without LN metastases or in patients with cancer in the LGA basin. The reproducibility of the results was also evaluated using an external validation dataset. Results: Of the 82 eligible patients, 79 (96.3%) were cured after undergoing LR + LGA-BD, 74 (90.2%) were pathologically negative for LN metastases, and 5 (6.1%) had LN metastases, but these findings were only observed in the LGA basin. Similarly, of the 406 eligible tumors in the validation dataset, 396 (97.5%) were potentially curative. Tumors in the lesser curvature, post-endoscopic resection status, and small tumors (<20 mm) were considered to be stronger indicators of LR + LGA-BD as all subpopulation cases met our feasibility criteria. Conclusions More than 95% of the patients with u-EGC might be eligible for LR + LGA-BD.This function-preserving procedure may contribute to the development of u-EGC without pathological LN metastases, especially for tumors located at the lesser curvature.

Objective: Substantial research has revealed cognitive function impairments in patients with major depressive disorder (MDD). However, the relationship between MDD cognitive function impairment and brain activity is yet to be elucidated. This study aimed to reveal this relationship using near-infrared spectroscopy (NIRS) to extensively measure frontotemporal cortex function. Methods: We recruited 18 inpatients with MDD and 22 healthy controls. Regional oxygenated hemoglobin changes (oxy-Hb) were measured during a verbal fluency task and its relationship to cognitive function was assessed. Cognitive function was assessed using the Japanese version of the Brief Assessment of Cognition in Schizophrenia. Results: Compared to healthy controls, patients with MDD displayed poorer motor speed, attention and speed of information processing, and executive function. In the bilateral prefrontal and temporal surface regions, regional oxy-Hb changes were significantly lower in patients with MDD than in healthy individuals. Moreover, we observed a correlation between reduced activation in the left temporal region and poor motor speed in patients with MDD. Conclusion We suggest that reduced activation in the left temporal region in patients with MDD could be a biomarker of poor motor speed. Additionally, NIRS may be useful as a noninvasive, clinical measurement tool for assessing motor speed in these patients.

No abstract available.
Adolescent ; Adult ; Age Factors ; Aged ; Aged, 80 and over ; Amino Acid Sequence ; Calreticulin/*genetics ; Child ; DNA/chemistry/genetics/metabolism ; Exons ; Female ; Humans ; Janus Kinase 2/*genetics ; Male ; Middle Aged ; Molecular Sequence Data ; Polymorphism, Single Nucleotide ; Receptors, Thrombopoietin/genetics ; Sequence Analysis, DNA ; Sex Factors ; Thrombocythemia, Essential/*diagnosis/genetics ; Young Adult

Objective: Currently, Risk Management Plans (RMPs), plan that provide new risk information about drugs, are published on the Pharmaceutical and Medical Devices Agency (PMDA) website.  The aim of this study was to compare enumerated risks in RMPs to the product labeling (PL) of the drug package insert.
Methods: The risks listed in RMPs on the PMDA website were assessed on February 10, 2014.  We investigated the documentation of these risks on the PL.
Results: Seven-hundred and eighty-five risks were enumerated in the RMPs of 77 drugs.  The enumerated risks were classified as “important identified risks” (66%), “important potential risks” (22%), and “important missing information” (12%).  Ninety-four percent of risks listed in RMPs were documented on the PL.  A portion of both the “important identified risks” and “important potential risks” groups were not documented on the PL.
Conclusion: This study was clearly the relation between risks listed in RMPs and documents on the PL.  Because a portion of the risks listed in RMPs was not documented on the PL, RMPs provide more safety information.  It is necessary to better understanding their characteristics, considering RMPs are a new source of drug information.

BACKGROUND: Reconstructed human epidermal culture skin models have been developed for cosmetic and pharmaceutical research. OBJECTIVE: This study evaluated the total and carboxyl esterase activities (i.e., K(m) and V(max), respectively) and localization in two reconstructed human epidermal culture skin models (LabCyte EPI-MODEL [Japan Tissue Engineering] and EpiDerm [MatTek/Kurabo]). The usefulness of the reconstruction cultured epidermis was also verified by comparison with human and rat epidermis. METHODS: Homogenized epidermal samples were fractioned by centrifugation. p-nitrophenyl acetate and 4-methylumbelliferyl acetate were used as substrates of total esterase and carboxyl esterase, respectively. RESULTS: Total and carboxyl esterase activities were present in the reconstructed human epidermal culture skin models and were localized in the cytosol. Moreover, the activities and localization were the same as those in human and rat epidermis. CONCLUSION: LabCyte EPI-MODEL and EpiDerm are potentially useful for esterase activity prediction in human epidermis.
Animals ; Centrifugation ; Cytosol ; Epidermis ; Humans ; Rats ; Skin*

Primary repair of the tetralogy of Fallot with absent pulmonary valve syndrome (TOF/APV) is associated with high mortality rates of 17-33%, especially in neonates. Our standard strategy involves a staged repair with a first palliation, performed during the neonatal period, that includes main pulmonary septation with an ePTFE patch, pulmonary arterioplasty for reduction of vascular dilation, and a modified Blalock-Taussig shunt. We performed successful repairs on two neonates with TOF/APV, one symptomatic and the other non-symptomatic, with this strategy. Case 1 : A 7-day-old boy had TOF/APV, with progressively worsening respiratory distress. His left bronchi, superior vena cava and left atrium were compressed by a dilated pulmonary artery, which was repaired by emergency surgery. Decreasing the diameter of the pulmonary artery (PA index from 2,550 to 525) relieved the compressed organs. Case 2 : A 16-day-old boy with TOF/APV with a main pulmonary artery that increased in diameter from 8 to 17 mm in the course of a single day. He was treated in the same fashion as Case 1. At 1 year of age, an intracardiac repair with tricuspid anuuloplasty was performed successfully. This strategy is much safer than a primary repair and is a good choice for neonatal repair of TOF/APV.

A 29-year-old woman, who had been diagnosed with Ebstein's anomaly associated with paroxysmal supraventricular tachycardia due to Wolff-Parkinson-White (WPW) syndrome, was referred to our hospital for treatment of congestive heart failure and tachycardia. She had undergone a catheter ablation for WPW syndrome at the age of 28 years. Subsequently, surgical treatment for Ebstein's anomaly was indicated because of persistent symptoms of heart failure due to tricuspid regurgitation (TR). The echocardiogram and pathologic findings corresponded to Ebstein's anomaly of the Carpentier type B classification, with severe displacement of the septal and posterior leaflets resulting in moderate TR. A mobile anterior leaflet of sufficient size without a cleft enabled us to successfully perform Hetzer's procedure. In this procedure, the large mobile anterior leaflet was approximated to the opposing true tricuspid annulus with a mattress suture of 3-0 polypropylene passed from the anterior leaflet annulus to the true tricuspid annulus at the site of atrialized right ventricle near the coronary sinus. The postoperative course was uneventful, and the cardiothoracic ratio reduced from 56% to 48% with mild TR. In this adult case of Carpentier's type B adult Ebstein's anomaly, Hetzer's procedure allowed reconstruction of the tricuspid valve mechanism of “leaflet-to-septum” coaptation at the level of the true annulus by approximating the anterior leaflet. This was, effective in reducing the patient's moderate TR. We conclude that this procedure is a simple and reproducible method for repairing the tricuspid valve in Ebstein's anomaly, especially for cases with a large mobile anterior leaflet.

Objective: Taking the wrong medicine or medication error is a serious concern to patient safety.  The aim of this study was to statistically survey the relation between the placement of drugs on medicine shelf and the occurrence of error in taking a medicine.
Methods: The study comprised 2 groups.  The incident group contained 43 cases that were erroneously taken in the Obihiro Kosei General Hospital.  The control group contained 43 drug pairs matched by the similarity index of the drug names from among the drugs used in the hospital at random.  The similarity index of drug names was based on 10 quantitative indicators.  The distance of medicine shelf arrangement was represented by three variables: the horizontal distance, the vertical distance and the distance of shelf block.  Conditional logistic regression analyses of the occurrence of medication errors were performed by evaluating the three variables of the distance factor and their interaction for error in taking a similar-sounding named drugs.
Results: Conditional logistic regression analysis revealed that the vertical distance (OR: 0.64, 95%CI: 0.42-0.99) and the distance of the shelf block (OR: 0.74, 95%CI: 0.57-0.97) were significant risk-reduction factors of medication errors.  Four variables were extracted as the most suitable logistic regression model in terms of the interaction between them.  As the interaction between 3 variables (the horizontal distance, the vertical distance and the distance of shelf block) was significant (OR: 0.93, 95%CI: 0.86-0.99), they may be considered as synergistic risk-reduction factors.  Moreover, the horizontal distance was found to be a risk-enhancement factor (OR: 1.52, 95%CI: 0.93-2.48).
Discussion: In order to reduce the risk of medication errors due to similar-sounding drug names, placement of drug on the medicine shelf should take into consideration the three coordinates of the distance factor.

Introduction: Mirtazapine is a noradrenergic and specific serotonergic antidepressant (NaSSA) and the previous reports show that may reduce nausea by inhibition of the serotonin 5-HT3receptor. Case report: A 38-year-old woman with advanced renal cancer with distant metastases was administered by sunitinib and oxycodone. Refractory nausea and vomiting developed during the course and mirtazapine at a daily dose of 1.875 mg was begun. The patient's nausea improved during the next day, and furthermore, by increasing the daily dose to 3.75 mg, vomiting was also improved on the third day. The therapy could be continued without withdrawal of sunitinib and oxycodone due to digestive symptoms. Although somnolence might be induced at a daily dose of 15 mg, the present low-dose mirtazapine could improve digestive symptoms without somnolence. Conclusion: We conclude that low-dose mirtazapine is one effective option for refractory nausea and vomiting during administration of sunitinib and oxycodone.