Objective: Burr hole trephination is a common treatment for chronic subdural hematoma, intracranial hematoma, and intraventricular hematoma due to its effective drainage of hematoma, minimal invasiveness and short operation time. However, cosmetic complications such as scalp depression can occur. The aim of this study was to evaluate the usefulness of an allogenic acellular dermal matrix (ADM) to prevent scalp depression at the burr hole site. Methods: A retrospective analysis was performed with 75 cases in 66 patients who were treated with burr hole trephination from January 2018 to December 2019. These cases divided into 2 groups; based on the method used to cover the burr hole site: Gelfoam packing only (GPO) and ADM. The degree of the scalp depression was measured from the more recent follow-up brain computed tomography scan. Results: There was a significant difference in the degree of scalp depression between GPO and ADM groups (p=0.003). No significant correlation between patient's age and the degree of scalp depression (GPO: p=0.419, ADM: p=0.790). There were no wound infection complication in either group. Conclusion ADM is a suitable material to prevent scalp depression after burr hole trephination.

Purpose: To provide a wider choice of treatment opportunities for patients with neuroendocrine tumor (NET) in Korea, we have conducted a phase 1, open-label, single-arm, dose-escalation study of SNU-KB-01, a no-carrier added (NCA) 177Lu-labeled DOTATATE. Materials and Methods: Seven patients with inoperable, progressive, metastatic, or locally advanced, somatostatin receptor-positive NET with Ki67 index ≤ 20% were enrolled according to the rolling six design. The study consisted of two cohorts to receive 4 cycles of SNU-KB-01 every 8 weeks for the first dose of 5.55 GBq (n=3) and 7.40 GBq (n=4). We assessed the incidence of dose-limiting toxicity (DLT) and adverse event, absorbed dose of kidneys and bone marrow, and objective tumor response. Results: Seven patients completed 4 cycles (21.3-30.1 GBq total dose) of SNU-KB-01. The mean absorbed doses to kidneys and bone marrow were 0.500 mGy/MBq and 0.053 mGy/MBq, respectively, and the total body effective dose was 0.115 mSv/MBq. No DLT was observed and the maximum tolerated dose was 7.40 GBq/cycle. Grade 3 thrombocytopenia occurred in one patient, but no other grade 3 or 4 major hematologic or renal toxicity was observed. The best objective response to SNU-KB-01 was partial response. Overall response rate was 42.9% and disease control rate was 85.7%. Conclusion Treatment with 4 cycles of SNU-KB-01 was well tolerated and resulted in control of disease in most of the patients. Our results indicate SNU-KB-01, an NCA 177Lu-labeled DOTATATE, as a potentially safe and efficacious treatment option for NET patients in Korea.

BACKGROUND: The numbers of patients on dialysis and their life expectancies are increasing. Reduced renal function is associated with an increased risk of cancer, but the cancer incidence and sites in dialysis patients compared with those of the general population require further investigation. We investigated the incidences of various cancers in dialysis patients in Korea and used national health insurance data to identify cancers that should be screened in dialysis clinics. METHODS: We accessed the Korean National Health Insurance Database and excerpted data using the International Classification of Disease codes for dialysis and malignancies. We included all patients who commenced dialysis between 2004 and 2013 and selected the same number of controls via propensity score matching. RESULTS: A total of 48,315 dialysis patients and controls were evaluated; of these, 2,504 (5.2%) dialysis patients and 2,201 (4.6%) controls developed cancer. The overall cancer risk was 1.54-fold higher in dialysis patients than in controls (adjusted hazard ratio, 1.71; 95% confidence interval, 1.61–1.81). The cancer incidence rate (incidence rate ratio [IRR], 3.27) was especially high in younger dialysis patients (aged 0–29 years). The most common malignancy of end-stage renal disease patients and controls was colorectal cancer. The major primary cancer sites in dialysis patients were liver and stomach, followed by the lung, kidney, and urinary tract. Kidney cancer exhibited the highest IRR (6.75), followed by upper urinary tract (4.00) and skin cancer (3.38). The rates of prostate cancer (0.54) and oropharyngeal cancer (0.72) were lower than those in the general population. CONCLUSION: Dialysis patients exhibited a higher incidence of malignancy than controls. Dialysis patients should be screened in terms of colorectal, liver, lung, kidney and urinary tract malignancies in dialysis clinics.
Colorectal Neoplasms ; Dialysis ; Epidemiology ; Humans ; Incidence ; International Classification of Diseases ; Kidney ; Kidney Failure, Chronic ; Kidney Neoplasms ; Korea ; Life Expectancy ; Liver ; Lung ; National Health Programs ; Oropharyngeal Neoplasms ; Propensity Score ; Prostatic Neoplasms ; Renal Dialysis ; Skin Neoplasms ; Stomach ; Urinary Tract

BACKGROUND: The converging epidemics of tuberculosis (TB) and end-stage renal disease (ESRD) have generated a significant public health burden, however, previous studies have been limited to a small number of patients. This nationwide cohort study aimed to assess the rate of developing active TB among patients receiving dialysis for ESRD. METHODS: The Korean national health insurance database was used to identify patients receiving dialysis for new-onset ESRD during 2004–2013, who were propensity score matched to an equivalent number of non-dialysis subjects from the general population. The incidences of active TB in the ESRD and control cohorts were calculated for 2004–2013, and multivariable Cox proportional hazards model was used to evaluate the ESRD-related risk of active TB. RESULTS: During 2004–2013, 59,584 patients received dialysis for newly diagnosed ESRD. In the dialysis and control cohorts, 457 (0.8%) and 125 (0.2%) cases of active TB were detected, respectively. Patients with ESRD were associated with a significantly higher risk of active TB compared to the controls (incidence rate ratio, 4.80). The ESRD cohort had an independently elevated risk of active TB (adjusted hazard ratio, 4.39; 95% confidence interval, 3.60–5.37). CONCLUSION: We found that patients receiving dialysis for ESRD had an elevated risk of active TB. These results highlight the need for detailed and well-organised guidelines for active TB screening among patients with ESRD.
Cohort Studies* ; Dialysis ; Humans ; Incidence ; Kidney Failure, Chronic* ; Korea ; Mass Screening ; National Health Programs ; Propensity Score ; Proportional Hazards Models ; Public Health ; Renal Insufficiency, Chronic ; Tuberculosis*

Background: We investigated the incidence and risk of retinal vein occlusion (RVO) in endstage renal disease (ESRD) patients on dialysis in Korea. Methods: In this nationwide cohort study, we used Korean National Health Insurance Service data between 2004 and 2013 for analysis. ESRD patients who started dialysis from 2004 to 2013 and an equal number of controls were selected through propensity score matching. RVO incidence in both cohorts were calculated for 2004–2013 using washout data from 2003. The multivariable Cox proportional hazards model was used to assess the risk of RVO in dialysis cohort. The Kaplan-Meier method was used to generate the cumulative RVO incidence curve.Whether the dialysis modality affects the development of RVO was also evaluated. Results: In this study, 74,551 ESRD patients on dialysis and the same number of controls were included. The incidence of RVO was significantly higher in the dialysis cohort than in the control cohort (dialysis = 7.3/1,000 person-years [PY]; control = 1.9/1,000 PY; P < 0.001). The cumulative-incidence of RVO was also significantly higher in the dialysis cohort than in the control cohort (P < 0.001; log-rank test). However, there was no significant difference in the incidence of RVO between the two dialysis methods (P = 0.550; log-rank test). Conclusion This study provided epidemiological evidence that receiving dialysis for ESRD could increase the risk of developing RVO. We also found a rapid increase in the incidence of RVO with a longer dialysis period. These results strengthen the relationship between retinal vascular disease and renal function.

Background: We investigated the incidence and risk of retinal vein occlusion (RVO) in endstage renal disease (ESRD) patients on dialysis in Korea. Methods: In this nationwide cohort study, we used Korean National Health Insurance Service data between 2004 and 2013 for analysis. ESRD patients who started dialysis from 2004 to 2013 and an equal number of controls were selected through propensity score matching. RVO incidence in both cohorts were calculated for 2004–2013 using washout data from 2003. The multivariable Cox proportional hazards model was used to assess the risk of RVO in dialysis cohort. The Kaplan-Meier method was used to generate the cumulative RVO incidence curve.Whether the dialysis modality affects the development of RVO was also evaluated. Results: In this study, 74,551 ESRD patients on dialysis and the same number of controls were included. The incidence of RVO was significantly higher in the dialysis cohort than in the control cohort (dialysis = 7.3/1,000 person-years [PY]; control = 1.9/1,000 PY; P < 0.001). The cumulative-incidence of RVO was also significantly higher in the dialysis cohort than in the control cohort (P < 0.001; log-rank test). However, there was no significant difference in the incidence of RVO between the two dialysis methods (P = 0.550; log-rank test). Conclusion This study provided epidemiological evidence that receiving dialysis for ESRD could increase the risk of developing RVO. We also found a rapid increase in the incidence of RVO with a longer dialysis period. These results strengthen the relationship between retinal vascular disease and renal function.

Patients on dialysis have numerous gastrointestinal problems related to uremia, which may represent concealed cholecystitis. We investigated the incidence and risk of acute cholecystitis in dialysis patients and used national health insurance data to identify acute cholecystitis in Korea. Methods: The Korean National Health Insurance Database was used, with excerpted data from the insurance claim of the International Classification of Diseases code of dialysis and acute cholecystitis treated with cholecystectomy. We included all patients who commenced dialysis between 2004 and 2013 and selected the same number of controls via propensity score matching. Results: A total of 59,999 dialysis and control patients were analyzed; of these, 3,940 dialysis patients (6.6%) and 647 controls (1.1%) developed acute cholecystitis. The overall incidence of acute cholecystitis was 8.04-fold higher in dialysis patients than in controls (95% confidence interval, 7.40–8.76). The acute cholecystitis incidence rate (incidence rate ratio, 23.13) was especially high in the oldest group of dialysis patients (aged ≥80 years) compared with that of controls. Dialysis was a significant risk factor for acute cholecystitis (adjusted hazard ratio, 8.94; 95% confidence interval, 8.19–9.76). Acute cholecystitis developed in 3,558 of 54,103 hemodialysis patients (6.6%) and in 382 of 5,896 patients (6.5%) undergoing peritoneal dialysis. Conclusion: Patients undergoing dialysis had a higher incidence and risk of acute cholecystitis than the general population. The possibility of a gallbladder disorder developing in patients with gastrointestinal problems should be considered in the dialysis clinic.

PURPOSE: Stool exams are a useful tool for the early presumptive diagnosis of infectious bacterial diarrhea in the Emergency Department (ED). CT scans are often used to increase the physician's level of certainty and to facilitate patient triage by identifying the source of pain in most patients with an acute abdomen in the ED. This study was designed to investigate the correlation between stool exams and abdominal CT in patients with acute diarrhea visiting the ED. METHODS: We conducted a retrospective study in the emergency department of a national university hospital from January 1, 2012 to June 30, 2013. The subjects consisted of 156 patients with acute diarrhea and abdominal pain who had stool exam results and abdominal CT findings. We divided the patients into three groups according to the stool exam results. Simultaneously, we evaluated their CT findings of the bowel and adjacent structures. RESULTS: A total of 156 patients were enrolled. Frequency of abnormal CT findings showed statistically significant correlation with stool exams (p-value <0.001). Abnormal CT findings increased as WBCs and RBCs in stool increased (p-value <0.001). CONCLUSION: The stool exam was a statistically significant predictive variable in indirectly determining the severity of acute diarrhea and it showed correlation with the frequency of abnormal CT findings. It is suggested that stool exams can be used as a susceptible marker for predicting the probability of severe infectious colitis, and for making an early decision regarding close medical attention.
Abdomen, Acute ; Abdominal Pain ; Colitis ; Diagnosis ; Diarrhea* ; Emergency Service, Hospital* ; Humans ; Retrospective Studies ; Tomography, X-Ray Computed ; Triage

OBJECTIVES: To circumvent the limitations of the current golden standard method, colony-forming unit (CFU) assay, for viability of Bacille Calmette–Guérin (BCG) vaccines, we developed a new method to rapidly and accurately determine the potency of BCG vaccines. METHODS: Based on flow cytometry (FACS) and fluorescein diacetate (FDA) as the most appropriate fluorescent staining reagent, 17 lots of BCG vaccines for percutaneous administration and 5 lots of BCG vaccines for intradermal administration were analyzed in this study. The percentage of viable cells measured by flow cytometry along with the total number of organisms in BCG vaccines, as determined on a cell counter, was used to quantify the number of viable cells. RESULTS: Pearson correlation coefficients of FACS and CFU assays for percutaneous and intradermal BCG vaccines were 0.6962 and 0.7428, respectively, indicating a high correlation. The coefficient of variation value of the FACS assay was less than 7%, which was 11 times lower than that of the CFU assay. CONCLUSION: This study contributes to the evaluation of new potency test method for FACS-based determination of viable cells in BCG vaccines. Accordingly, quality control of BCG vaccines can be significantly improved.
Administration, Cutaneous ; BCG Vaccine ; Cell Count ; Flow Cytometry* ; Fluorescein ; Methods ; Mycobacterium bovis ; Quality Control ; Stem Cells ; Vaccine Potency ; Vaccines*

Objective: 68 Ga-NGUL is a novel prostate-specific membrane antigen (PSMA)-targeting tracer based on Glu-Urea-Lys derivatives conjugated to a 1,4,7-triazacyclononane-N,N’,N’’-triacetic acid (NOTA) chelator via a thiourea-type short linker. This phase I clinical trial of 68 Ga-NGUL was conducted to evaluate the safety and radiation dosimetry of 68 Ga-NGUL in healthy volunteers and the lesion detection rate of 68 Ga-NGUL in patients with prostate cancer. Materials and Methods: We designed a prospective, open-label, single-arm clinical trial with two cohorts comprising six healthy adult men and six patients with metastatic prostate cancer. Safety and blood test-based toxicities were monitored throughout the study. PET/CT scans were acquired at multiple time points after administering 68 Ga-NGUL (2 MBq/kg; 96–165 MBq). In healthy adults, absorbed organ doses and effective doses were calculated using the OLINDA/EXM software. In patients with prostate cancer, the rates of detecting suspicious lesions by 68 Ga-NGUL PET/CT and conventional imaging (CT and bone scintigraphy) during the screening period, within one month after recruitment, were compared. Results: All 12 participants (six healthy adults aged 31–32 years and six prostate cancer patients aged 57–81 years) completed the clinical trial. No drug-related adverse events were observed. In the healthy adult group, 68 Ga-NGUL was rapidly distributed, with the highest uptake in the kidneys. The median effective dose coefficient was calculated as 0.025 mSv/MBq, and cumulative activity in the bladder had the highest contribution. In patients with metastatic prostate cancer, 229 suspicious lesions were detected using either 68 Ga-NGUL PET/CT or conventional imaging. Among them, 68 Ga-NGUL PET/CT detected 199 (86.9%) lesions and CT or bone scintigraphy detected 114 (49.8%) lesions. Conclusion 68 Ga-NGUL can be safely applied clinically and has shown a higher detection rate for the localization of metastatic lesions in prostate cancer than conventional imaging. Therefore, 68 Ga-NGUL is a valuable option for prostate cancer imaging.