Ise Red Cross Hospital

Abstract Introduction Maintaining dose intensity is essential for the efficacy of adjuvant S-1 chemotherapy in gastric cancer. Although pharmacist interventions can reduce toxicity and improve adherence, multicenter evidence regarding their impact on dose maintenance is limited. Aim This study aimed to evaluate the impact of continuous pharmacist intervention on treatment completion and relative performance (RP) value in patients receiving adjuvant S-1 chemotherapy for gastric cancer. Methods This multicenter retrospective study analysed 225 patients across 12 institutions, categorised into continuous intervention (n=97) and non-continuous intervention (n=128) groups. Continuous intervention was defined as systematic monitoring and management for at least 50% of the treatment duration. Inverse probability of treatment weighting adjusted for baseline covariates. The primary and secondary endpoints were the eight-cycle completion rate and the RP value, respectively. Results Eight-cycle completion rate did not differ significantly between the continuous and non-continuous intervention groups (53.0% vs. 55.2%, p = 0.775), nor did the frequency of treatment modification events, including discontinuation or dose reduction. However, the RP value was significantly higher in the continuous intervention group than in the non-continuous intervention group (73.7% vs. 64.9%, p = 0.038), a finding robustly supported by sensitivity analysis between these two groups (75.1% vs. 61.1%, p = 0.0008). The continuous group maintained a high intervention rate (89.1%) throughout the final cycle, providing significantly more supportive care interventions than the non-continuous intervention group (53.2% vs. 4.9%, p < 0.001). Conclusion Although continuous pharmacist intervention did not improve the binary completion rate, it was essential for maintaining RP values above the clinically essential 70% threshold through proactive toxicity management and dynamic dose optimization. These findings suggest that systematic pharmaceutical care contributes significantly to ensuring the quality and intensity of adjuvant chemotherapy.

Although eating habits of "vegetables first" have been reported to be effective in suppressing postprandial hyperglycemia, its association with complications in diabetic patients remains unknown. This study aimed to examine the relationship between the habit of eating vegetables first and complications in diabetic patients. This cross-sectional study included diabetic patients who were examined as outpatients at the Ise Red Cross Hospital from June to August 2023 and from June to August 2024. The complications were diagnosed according to the clinical guidelines of the Japan Diabetes Society. Participants completed a questionnaire about their eating order, classified into four groups: no order, vegetables first, protein first, and carbohydrates first. Logistic regression analysis was used to calculate odds ratios for complications based on eating order. The results revealed that 204 patients ate in no order, 438 patients ate vegetables first, 59 patients ate protein first, and 131 patients ate carbohydrates first. The adjusted odds ratios for diabetic retinopathy, diabetic neuropathy, diabetic nephropathy, and cardiovascular disease for vegetables first with no order of eating as the reference were 0.64 (95% confidence interval [CI], 0.41-0.98; P = 0.043), 0.80 (95% CI, 0.53-1.20; P = 0.289), 0.47 (95% CI, 0.30-0.71; P < 0.001), and 1.28 (95% CI, 0.76-2.15; P = 0.351), respectively. Neither the protein first nor carbohydrates first groups showed a significant association with complications. In diabetic patients, the habit of eating vegetables first may indicate a reduced risk of diabetic retinopathy and nephropathy.

Non-operative management (NOM) has become the standard of care for blunt solid organ injury, with angioembolization (AE) playing a key role in achieving hemostasis, particularly in liver trauma. Although the dual blood supply to the liver provides relative protection against ischemia, AE can disrupt this balance and lead to major hepatic necrosis (MHN), a life- threatening complication associated with significant morbidity and mortality. Early identification of patients at risk of developing MHN is critical but remains challenging. While treatment strategies for MHN have been explored, early predictive markers, especially angiographic findings, remain underreported and are not yet established in the literature. We report a rare intrahepatic hemodynamic phenomenon observed on angiography that may serve as an early predictor of MHN. A 32-year-old man sustained a Grade III liver injury predominantly involving the left hepatic lobe following a motor vehicle collision. Contrast-enhanced CT showed hepatic parenchymal injury with hemoperitoneum. Although no active extravasation was observed, contrast enhancement was noted in the left portal vein branch during the arterial phase. Selective angiography via the left hepatic artery revealed parenchymal enhancement of the left hepatic lobe, followed by retrograde opacification of the left portal vein branch. Notably, contrast did not proceed into the left hepatic vein, suggesting impaired hepatic venous outflow. This hemodynamic pattern, characterized by trans-sinusoidal arterial-to-portal flow without venous drainage, can be termed traumatic outflow block (TOFB), a phenomenon not previously reported in trauma. Despite this atypical flow pattern, AE was performed using gelatin sponge particles. The patient subsequently developed abdominal pain and fever, and CT showed non-perfusion of the lateral liver segment. Emergency surgery confirmed massive hepatic necrosis and lateral segmentectomy was performed. Intraoperatively, there were no observable lacerations or disruptions of the portal vein or hepatic veins. However, the liver parenchyma near the root of the left hepatic vein exhibited substantial contusion and hematoma, suggesting possible venous compression. The patient made an uneventful recovery and was discharged on postoperative day nine. TOFB is a novel angiographic finding suggestive of hepatic venous congestion and may serve as an early predictor of MHN after embolization. While therapeutic strategies for TOFB remain undefined, early recognition of this hemodynamic pattern could guide selective embolization, prompt monitoring and potentially improve outcomes in patients with severe liver trauma.

Chronic postoperative inguinal pain (CPIP) is a major complication of inguinal hernia repair and significantly affects patients' quality of life. Despite the widespread use of transabdominal preperitoneal repair (TAPP), CPIP still occurs. In TAPP, nerves are not directly exposed, and surgeons avoid complications by identifying the trapezoid of disaster (ToD) using anatomical landmarks. This study evaluates an AI-based system that displays these landmarks on intraoperative endoscopic images. We analyzed 62 randomly selected TAPP cases (73 hernias) from 188 procedures (222 hernias) performed at our institution. A total of 3323 images of the myopectineal orifice were labeled for training. We developed a Feature Pyramid Network (FPN) segmentation model using EfficientNetB7. The model was tested on 10 new cases to identify three key landmarks: vas deferens, gonadal vessels, and inferior epigastric vessels. Expert surgeons validated the prototype system. Postoperative pain was observed in 5.4% (12 cases) for Numerical rating scale (NRS) ≥ 1 and 2.2% (5 cases) for CPIP (NRS ≥ 3). The model achieved Dice coefficients of 0.67 (vas deferens), 0.68 (gonadal vessels) and 0.70 (inferior epigastric vessels). Anatomical landmarks were successfully displayed on surgical images. Expert evaluation confirmed correct recognition in 90% of cases. The AI model accurately identified key anatomical landmarks in TAPP and demonstrated anatomical validity. Surgical safety may be improved by avoiding nerve damage through visualization of key structures.

To evaluate the utility of the Geriatric Nutritional Risk Index (GNRI) in predicting nonhome discharge (NHD) and delayed discharge after elective thoracic endovascular aortic repair (TEVAR). The study population included patients undergoing elective simple TEVAR for intact thoracic aortic aneurysm or subacute or chronic aortic dissection between January 2009 and December 2022 and not experiencing neurological complications or re-interventions during hospitalization. The primary outcome measure was NHD and significantly delayed discharge. GNRI was calculated using the following equation: GNRI = 14.89 × serum albumin (g/dL) + 41.7 × (body mass index [kg/m2] / 22). A univariable logistic regression model was used to determine the odds ratio for GNRI. The predictive performance of GNRI was evaluated using the area under the receiver operating characteristic curve (AUC). A total of 229 patients were analyzed and the overall rate of the primary outcome was 5.7% (NHD, n = 6; delayed discharge, n = 10; both, n = 3). Patients with the primary outcome were more likely to have a lower GNRI (98 vs 103; P = .01) than those without. The logistic regression model showed that a high GNRI was protective against NHD (odds ratio, 0.38; 95% confidence interval, 0.18-0.76; P = .008). The AUC for GNRI was 0.710 (95% confidence interval, 0.602-0.821). The sensitivity, specificity, positive predictive value, and negative predictive value of GNRI < 92 were 23%, 89%, 11%, and 95%, respectively. Preoperative evaluation of GNRI may be useful in predicting NHD and delayed discharge.

BackgroundUnresectable malignant bile duct stricture (often caused by unresectable pancreatic cancer and cholangiocarcinoma) can be drained via insertion of self-expandable metal stents (SEMS) during endoscopic retrograde cholangiopancreatography (ERCP). Because recurrent biliary obstruction (RBO) and complications following stent insertion can delay chemotherapy and other treatments, a longer time to RBO (TRBO) is desirable. Although a longer TRBO has been reported among patients who undergo insertion with larger diameter SEMS, patients who undergo insertion with smaller diameter fully covered SEMS (FCSEMS) may have a lower incidence of complications than those with larger diameter FCSEMS. The aim of this study is to determine the TRBO and incidence of complications with 6-mm FCSEMS vs 10-mm FCSEMS in patients with unresectable malignant distal bile duct stricture.MethodsIn this multicenter, open-label, randomized controlled, non-inferiority trial (COSMIC UNISON), a target of 250 patients over 23 locations in Japan will receive either the 6-mm FCSEM or the standard 10-mm FCSEM during ERCP, with 125 patients in each group. The observation period will be 24 months, and patients will be enrolled from 15 March 2024 and assessed until the date of RBO or the study end (31 March 2029). The primary endpoint is TRBO, with RBO defined as the coexistence of abnormal liver enzyme values and dilation of the common bile duct and intrahepatic bile duct upstream of the stent. The secondary endpoints are the incidence and rates (at 3, 6, and 12 months) of non-RBO events, overall survival, cause of RBO, and symptomatic stent deviation. Adverse events from endoscopic procedures will be classified by the Lexicon Classification from the American Society of Endoscopy, and all other adverse events will be classified per the Japanese translation of the Common Terminology Criteria for Adverse Events version 5.0.DiscussionThe COSMIC UNISON study is anticipated to provide evidence regarding the efficacy and safety of 6-mm vs 10-mm FCSEMS to inform the use of 6-mm FCSEMS for the treatment of unresectable malignant distal bile duct stricture.Trial registrationJapan Registry of Clinical Trials identifier: jRCT1042230170. Prospectively registered on 15 March 2024.

It is sometimes difficult to secure the airway in cases of head and neck cancer spreading to the mediastinum. We report 2 such cases in which we prevented airway obstruction by using an airway stent.

ObjectiveFutile recanalization (FR)—a poor functional outcome despite successful reperfusion after mechanical thrombectomy (MT)—remains a significant issue in acute ischemic stroke owing to large vessel occlusion. This study aimed to identify predictors of FR, focusing on CT perfusion (CTP) parameters using our institutional retrospective data.MethodsPatients who underwent MT at our institution between April 2015 and February 2023 were retrospectively reviewed. FR was defined as a 90-day modified Rankin Scale (mRS) score of 3–6 despite successful reperfusion (modified thrombolysis in cerebral infarction ≥2b). Patients with internal carotid artery (ICA) or M1 segment of the middle cerebral artery occlusion, pre-stroke mRS 0–2, stroke etiology classified as cardioembolic or embolic stroke of undetermined source, and available CTP were included. The ischemic core was defined as cerebral blood volume (CBV) <1.0 mL/100 g on CTP, and the Alberta Stroke Program Early CT Score (ASPECTS) was also evaluated. Clinical, imaging, and procedural variables were compared between the FR group and those with a favorable outcome (mRS 0–2) after successful reperfusion. Multivariable logistic regression was performed, including imaging markers and variables with p <0.1 in univariate analyses as covariates. Receiver-operating characteristic (ROC) analyses determined thresholds for ASPECTS and CBV-defined core volume, followed by sensitivity analyses.ResultsA total of 531 patients underwent MT during the study period, of whom 136 met the inclusion criteria (mean age 78 ± 11 years, 70 women, 46 ICA occlusions, median ASPECTS 9; interquartile range, 7–10). FR was observed in 69 patients (50.8%). Compared with the favorable outcome group, the FR group had significantly older age, higher baseline NIHSS scores, higher prevalence of diabetes mellitus, lower ASPECTS, larger CBV-defined core volumes, and a greater total number of device passes. Multivariable logistic regression identified older age, higher NIHSS, diabetes mellitus, and a greater total number of device passes as consistently independent predictors of FR. ROC analysis identified CBV-defined core volume ≥28.5 mL as an independent predictor of FR (area under the curve [AUC] 0.62, p = 0.013; adjusted odds ratio [aOR] 3.09, 95% confidence interval [CI] 1.23–8.28; p = 0.02); this association remained significant at ≥30 mL (aOR 2.82, 95% CI 1.14–7.33; p = 0.02) but not at ≥40 mL. ASPECTS ≤8 was also associated with FR (AUC 0.64, p = 0.002; aOR 2.92, 95% CI 1.20–7.44; p = 0.02).ConclusionOlder age, baseline stroke severity, diabetes mellitus, and multiple device passes were major predictors of FR. Among imaging markers, a CBV-defined core volume of approximately 30 mL emerged as a clinically relevant threshold associated with increased FR risk. These findings suggest that integrating clinical, procedural, and imaging factors may help optimize patient selection, although validation in larger, multicenter studies is warranted.

Japan has adopted its own reimbursement system, which differs from other countries in terms of its diagnostic procedure combination (DPC) methods. However, there are few reports on the cost analysis of open repair and endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms in Japan. We aimed to evaluate the long-term outcomes and cost-effectiveness of these two procedures. This study included patients who underwent open repair (n = 224) and EVAR (n = 87) between January 2012 and December 2022. After propensity score matching, we compared the two groups. The drug and blood products, procedures, and DPC costs were significantly higher in the open repair group (p < 0.001) than in the EVAR group. The surgical equipment and total costs were significantly higher in the EVAR group than in the open repair group (p < 0.001). There was no significant difference in the 5-year survival rate (88.5% in the open repair group vs. 72.0% in the EVAR group; p = 0.33) and freedom from re-intervention rate at 5years (93.1% in the open repair group vs. 89.9% in the EVAR group; p = 0.15) between the two groups. Open repair is more cost-effective than EVAR. The cost-effectiveness of EVAR may therefore depend on the cost of the endograft.

Background/Objectives: FVIII reagent activity varies across different assays, as well as activated partial thromboplastin time (APTT) reagents. The hemostatic ability of various FVIII reagents was examined via clot waveform analysis (CWA). Methods: APTT was measured using 12 APTT reagents, a small amount of tissue factor-induced FIX activation (sTF/FIXa) and a small amount of thrombin time (sTT) in order to examine 10 FVIII reagents and reference plasma (RP) using CWA. FVIII activity was measured using CWA-APTT, a chromogenic assay, or CWA-sTT. Results: Although the peak time (PT) and peak height (PH) of the CWA-APTT were markedly different in different FVIII reagents using several APTT reagents, the PTs of CWA-APTT were generally normal or shortened and the PHs of CWA-APTT were generally lower than those of RP. The FVIII activity varied, as evaluated using APTT, and was higher when using the CWA-sTT method than the APTT or chromogenic methods. CWA-sTT showed an elevated second peak of first DPH in all FVIII reagents, and both CWA-sTF/FIXa and CWA-sTT were enhanced using APTT reagents. Conclusions: Our evaluation of the hemostatic ability of FVIII reagents varied among APTT reagents. CWA-sTT can be used to further evaluate the hemostatic ability of an FVIII concentrate based on thrombin burst.