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: To evaluate the impact of severe erectile dysfunction (ED) on future major adverse cardiovascular events (MACE) in men on dialysis. Materials and Methods: This prospective cohort study included 71 men on dialysis. ED was assessed using the Sexual Health Inventory for Men (SHIM). Men were divided into the mild/moderate ED (SHIM score ≥8) and severe ED (SHIM score ≤7) groups. The primary endpoint was MACE-free survival. MACE was a composite of myocardial infarction, cardiovascular death, and stroke. The secondary endpoints were cardiac event-free survival and overall survival (OS). Moreover, the predictive abilities of severe ED for 5-year MACE, 5-year cardiac events, and 5-year overall mortality were evaluated. Results: The median age and follow-up period of the included men were 64 years and 58 months, respectively. The median SHIM score was 4.0; all had a degree of ED, and 64.7% had severe ED. In the background-adjusted multivariable analyses, severe ED was not significantly associated with shorter MACE-free survival (hazard ratio [HR], 1.890; 95% confidence interval [CI], 0.533–6.706; p=0.324), cardiac event-free survival (HR, 2.081; 95% CI, 0.687–6.304; p=0.195), and OS (HR, 0.817; 95% CI, 0.358–1.863; p=0.630). Severe ED did not significantly improve the predictive abilities for 5-year MACE, 5-year cardiac events, and 5-year overall mortality (p=0.110, p=0.101, and p=0.740, respectively). Conclusions ED severity was not associated with shorter MACE-free survival, cardiac event-free survival, or OS, and ED severity could not improve the predictive abilities for these outcomes in men undergoing dialysis.

Objective：Although prediction of functional recovery after lacunar infarction is challenging, quantitative evaluation of brain imaging may be promising. In this article, we investigate association of the amount of corticospinal tract (CST) injury on Computed Tomography (CT) and functional recovery of lacunar infarction in the corona radiata.Methods：In 24 patients with lacunar infarction of the corona radiata, we investigated association of the amount of virtual CST injury with upper and lower limb motor function at 90 days after the stroke onset. The optimal area of the virtual CST to predict motor function was also determined. Finally, we evaluated whether the quantitative CST injury predicted practical motor function regarding activities of daily living.Results：The amount of virtual CST injury, evaluated with Hounsfield unit value of CT, was significantly associated with upper and lower limb function at 90 days after stroke onset. Among them, 6 mm radius CST circle for upper limb had the highest regression coefficient to predict Brunnstrom stage for the upper extremity (R2＝0.69), grip strength (R2＝0.52) and Simple Test for Evaluating Hand function (R2＝0.75). Also, 7 mm radius CST circle for lower limb had the highest regression coefficient to predict Brunnstrom stage for the lower extremity (R2＝0.51), weight bearing index (R2＝0.53) and Berg Balance Scale (R2＝0.52). These virtual CSTs predicted practical function including practical upper limb and ambulation.Conclusion：Quantitative evaluation of CST on CT predicted functional recovery after lacunar infarction of the corona radiata.

Objective：Although prediction of functional recovery after lacunar infarction is challenging, quantitative evaluation of brain imaging may be promising. In this article, we investigate association of the amount of corticospinal tract (CST) injury on Computed Tomography (CT) and functional recovery of lacunar infarction in the corona radiata.Methods：In 24 patients with lacunar infarction of the corona radiata, we investigated association of the amount of virtual CST injury with upper and lower limb motor function at 90 days after the stroke onset. The optimal area of the virtual CST to predict motor function was also determined. Finally, we evaluated whether the quantitative CST injury predicted practical motor function regarding activities of daily living.Results：The amount of virtual CST injury, evaluated with Hounsfield unit value of CT, was significantly associated with upper and lower limb function at 90 days after stroke onset. Among them, 6 mm radius CST circle for upper limb had the highest regression coefficient to predict Brunnstrom stage for the upper extremity (R2＝0.69), grip strength (R2＝0.52) and Simple Test for Evaluating Hand function (R2＝0.75). Also, 7 mm radius CST circle for lower limb had the highest regression coefficient to predict Brunnstrom stage for the lower extremity (R2＝0.51), weight bearing index (R2＝0.53) and Berg Balance Scale (R2＝0.52). These virtual CSTs predicted practical function including practical upper limb and ambulation.Conclusion：Quantitative evaluation of CST on CT predicted functional recovery after lacunar infarction of the corona radiata.

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.

Central venous lesions are suspected in dialysis patients who present with increased venous pressure and severe swelling of the shunt arm. Here, we report a case where contrast computed tomography (CT) was useful for diagnosis. Iopamidol 300 (20 mL) was diluted 2-fold, 30 mL of which was injected into the vein in the shunt arm at 2.0 mL/s. Imaging was started 10 s later. Fixed stenosis caused by intimal proliferation can be assessed just as effectively using contrast CT and shunt angiography. However, contrast CT is more useful than shunt angiography in the assessment of stenosis due to compression by surrounding organs and lesions, because the position of vessels relative to surrounding organs can be depicted. Contrast CT allows for safer and shorter examination compared with shunt angiography, and the diagnostic performance of a single examination can be improved using 3-dimensional reconstruction (3D) and multiplanar reformation images. Precise information obtained using contrast CT will contribute to safe and effective percutaneous transluminal angioplasty.

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.