Background: As the number of large-scale studies involving multiple organizations producing data has steadily increased, an integrated system for a common interoperable format is needed. In response to the coronavirus disease 2019 (COVID-19) pandemic, a number of global efforts are underway to develop vaccines and therapeutics. We are therefore observing an explosion in the proliferation of COVID-19 data, and interoperability is highly requested in multiple institutions participating simultaneously in COVID-19 pandemic research. Results: In this study, a laboratory information management system (LIMS) approach has been adopted to systemically manage various COVID-19 non-clinical trial data, including mortality, clinical signs, body weight, body temperature, organ weights, viral titer (viral replication and viral RNA), and multiorgan histopathology, from multiple institutions based on a web interface. The main aim of the implemented system is to integrate, standardize, and organize data collected from laboratories in multiple institutes for COVID-19 non-clinical efficacy testings. Six animal biosafety level 3 institutions proved the feasibility of our system. Substantial benefits were shown by maximizing collaborative high-quality non-clinical research. Conclusions This LIMS platform can be used for future outbreaks, leading to accelerated medical product development through the systematic management of extensive data from non-clinical animal studies.

Background/Aims: Untreated rupture of the thoracic aorta is associated with a high mortality rate. We aimed to review the clinical results of endovascular treatment for ruptured thoracic aortic disease. Methods: We retrospectively reviewed data on 37 patients (mean age, 67.0 ± 15.18 years) treated for ruptured thoracic aortic disease from January 2005 to May 2016. The median follow-up duration was 308 days (interquartile range, 61 to 1,036.5). The primary end-point of the study was the composite of death, secondary intervention, endoleak, and major stroke/paraplegia after endovascular treatment. Results: The etiologies of ruptured thoracic aortic disease were aortic dissection (n = 11, 29.7%), intramural hematoma (n = 7, 18.9%), thoracic aortic aneurysm (n = 14, 37.8%), and traumatic aortic transection (n = 5, 13.5%). Three patients died within 24 hours of thoracic endovascular aortic repair, and one showed type I endoleak. The technical success rate was 89.2% (33/37). The in-hospital mortality rate was 13.5% (5/37); no deaths occurred during follow-up. The composite outcome rate during follow-up was 37.8% (14/37), comprising death (n = 5, 13.5%), secondary intervention (n = 5, 13.5%), endoleak (n = 5, 13.5%), and major stroke/paraplegia (n = 3, 8.1%). Left subclavian artery revascularization and proximal landing zone were not associated with the composite outcome. Low mean arterial pressure (MAP; ≤ 60 mmHg, [hazard ratio, 13.018; 95% confidence interval, 2.435 to 69.583, p = 0.003]) was the most significant predictor and high transfusion requirement in the first 24 hours was associated with event-free survival (log rank p = 0.018). Conclusions Endovascular treatment achieves high technical success rates and acceptable clinical outcome. High transfusion volume and low MAP were associated with poor clinical outcomes.

PURPOSE: To date, the parameters for evaluating enucleation efficiency have only considered enucleation time, although operators simultaneously consume both time and energy during holmium laser enucleation of the prostate. This study was undertaken to find a better way of assessing enucleation skills, considering both enucleation time and consumed energy. MATERIALS AND METHODS: One hundred (n=100) consecutive patients who underwent holmium laser enucleation of the prostate from April 2012 to April 2014 by a single surgeon were enrolled. Ten groups of 10 consecutive cases were used to analyze the parameters of enucleation efficiency. RESULTS: The mean enucleation time, consumed energy, and enucleated weight were 41.3±19.2 minutes, 66.2±36.0 kJ, and 26.6±21.8 g, respectively. Concerning learning curves, like enucleation time-efficacy (=enucleated weight/enucleation time), enucleation energy-efficacy (=enucleated weight/consumed energy) also had an increasing tendency. Enucleation ratio efficacy (=enucleated weight/transitional zone volume/enucleation time) plateaued after 30 cases. However, enucleation time-energy-efficacy (=enucleated weight/enucleation time/consumed energy) continued to increase after 30 cases and plateaued at 61 to 70 cases. Furthermore, one-way analysis of variance showed that group means for enucleation time-energy-efficacy (F=3.560, p=0.001) were significantly different, but that those of enucleation ratio efficacy (F=1.931, p=0.057) were not. CONCLUSIONS: When both time and energy were considered, enucleation skills continued to improve even after 30 cases and plateaued at 61 to 70 cases. Therefore, we propose that enucleation time-energy-efficacy should be used as a more appropriate parameter than enucleation ratio efficacy for evaluating enucleation skills.
Holmium ; Humans ; Lasers, Solid-State ; Learning Curve ; Prostate ; Prostatic Hyperplasia

Gastrointestinal endoscopy plays an important diagnostic and therapeutic role in the field of gastrointestinal disease. As endoscopies have become more common due to the nationwide screening program for digestive cancer and an increasing interest in health among the general public, the risk of infection transmission between patients has emerged as a clinical challenge. Although endoscopes can become highly contaminated with secretions and blood during use, the thorough reprocessing of an endoscope before it is reused in subsequent patients can be difficult due to its complicated structure. Although the incidence of endoscopy-associated infections has been reported to be extremely low, compelling evidence suggests that the actual incidence is underestimated. It has been well established that endoscopes reprocessed appropriately, in accordance with standard guidelines, have no risk of infection transmission. Although revised guidelines for endoscope reprocessing were released in Korea in 2015, suboptimal infection prevention practices during endoscope reprocessing have been reported. Under these circumstances, the Korean Society of Digestive Endoscopy developed the ‘Guidelines of cleaning and disinfection in gastrointestinal endoscope for clinicians’ based on the currently available evidence. These guidelines provide accurate and updated information on reprocessing techniques, and can help improve the quality of reprocessing and compliance by health care personnel. As a result, infection control during gastrointestinal endoscopies can be expected to be achieved in Korea.
Compliance ; Delivery of Health Care ; Disease Transmission, Infectious ; Disinfection ; Endoscopes ; Endoscopes, Gastrointestinal ; Endoscopy ; Endoscopy, Gastrointestinal ; Gastrointestinal Diseases ; Humans ; Incidence ; Infection Control ; Korea ; Mass Screening

Gastrointestinal endoscopy plays an important diagnostic and therapeutic role in the field of gastrointestinal disease. As endoscopies have become more common due to the nationwide screening program for digestive cancer and an increasing interest in health among the general public, the risk of infection transmission between patients has emerged as a clinical challenge. Although endoscopes can become highly contaminated with secretions and blood during use, the thorough reprocessing of an endoscope before it is reused in subsequent patients can be difficult due to its complicated structure. Although the incidence of endoscopy-associated infections has been reported to be extremely low, compelling evidence suggests that the actual incidence is underestimated. It has been well established that endoscopes reprocessed appropriately, in accordance with standard guidelines, have no risk of infection transmission. Although revised guidelines for endoscope reprocessing were released in Korea in 2015, suboptimal infection prevention practices during endoscope reprocessing have been reported. Under these circumstances, the Korean Society of Digestive Endoscopy developed the ‘Guidelines of cleaning and disinfection in gastrointestinal endoscope for clinicians’ based on the currently available evidence. These guidelines provide accurate and updated information on reprocessing techniques, and can help improve the quality of reprocessing and compliance by health care personnel. As a result, infection control during gastrointestinal endoscopies can be expected to be achieved in Korea.

BACKGROUND/AIMS: The objective of this study was to investigate the value of cyst fluid carcinoembryonic antigen (CEA) in combination with cytology and viscosity for the differential diagnosis of pancreatic cysts. METHODS: We retrospectively reviewed our data for patients who underwent endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) and cyst fluid analysis. We investigated the sensitivity, specificity and accuracy of the combination of cyst fluid CEA, cytology and viscosity testing. RESULTS: A total of 177 patients underwent EUS-FNA and cyst fluid analysis. Of these, 48 subjects were histologically and clinically confirmed to have pancreatic cysts and were therefore included in the analysis. Receiver operator curve analysis demonstrated that the optimal cutoff value of cyst fluid CEA for differentiating mucinous versus nonmucinous cystic lesions was 48.6 ng/mL. The accuracy of cyst fluid CEA (39/48, 81.3%) was greater than the accuracy of cytology (23/45, 51.1%) or the string sign (33/47, 70.2%). Cyst fluid CEA in combination with cytology and string sign assessment exhibited the highest accuracy (45/48, 93.8%). CONCLUSIONS: Cyst fluid CEA was the most useful single test for identifying mucinous pancreatic cysts. The addition of cytology and string sign assessment to cyst fluid CEA increased the overall accuracy for the diagnosis of mucinous pancreatic cysts.
Carcinoembryonic Antigen* ; Cyst Fluid* ; Diagnosis ; Diagnosis, Differential ; Endoscopic Ultrasound-Guided Fine Needle Aspiration ; Humans ; Mucins* ; Pancreatic Cyst* ; Retrospective Studies ; Sensitivity and Specificity ; Viscosity*

BACKGROUND/AIMS: Chronic thromboembolic pulmonary hypertension (CTEPH) is a life-threatening complication after acute pulmonary embolism (APE) and is associated with substantial morbidity and mortality. This study aimed to investigate the incidence of CTEPH after APE in Korea and to determine echocardiographic predictors of CTEPH. METHODS: Among 381 patients with APE confirmed by chest computed tomography (CT) between January 2007 and July 2013, 246 consecutive patients with available echocardiographic data were enrolled in this study. CTEPH was defined as a persistent right ventricular systolic pressure (RVSP) greater than 35 mmHg on echocardiography during follow-up and persistent pulmonary embolism on the follow-up CT. RESULTS: Fifteen patients (6.1%) had CTEPH. The rate of right ventricular (RV) dilatation (66.7% vs. 28.1%, p = 0.002) and the RVSP (75.5 mmHg vs. 39.0 mmHg, p < 0.001) were significantly higher in the CTEPH group. D-dimers, RV dilatation, RV hypertrophy, RVSP, and intermediate-risk APE were associated with the risk of CTEPH after APE (odds ratio [OR] 0.59, 5.11, 7.82, 1.06, and 4.86, respectively) on univariate analysis. RVSP remained as a significant predictor of CTEPH on multivariate analysis (OR, 1.056; 95% confidence interval, 1.006 to 1.109; p = 0.029). CONCLUSIONS: This study showed that the incidence of CTEPH after APE in Korea was 6.1% and that initial RVSP by echocardiography was a strong prognostic factor for CTEPH.
Blood Pressure ; Dilatation ; Echocardiography* ; Follow-Up Studies ; Hominidae ; Humans ; Hypertension, Pulmonary* ; Hypertrophy ; Incidence ; Korea* ; Mortality ; Multivariate Analysis ; Pulmonary Embolism* ; Thorax

BACKGROUND AND OBJECTIVES: Statins remain the mainstay of secondary coronary artery disease (CAD) prevention, but n-3 polyunsaturated fatty acids (ω-3 PUFA) display biological effects that may also reduce the risk of atherosclerosis and CAD. However, data on the possible antiatherosclerotic benefits of adding ω-3 PUFA to statin therapy are limited. This study aimed to investigate the potential additive effects of ω-3 PUFA on regression of atherosclerosis in CAD patients receiving statin therapy and stent implantation. SUBJECTS AND METHODS: Seventy-four CAD patients undergoing percutaneous coronary intervention (PCI) with stent implantation were enrolled, prescribed statins, and randomly assigned to two groups: n-3 group (ω-3 PUFA 3 g/day, n=38) or placebo group (placebo, n=36). All patients completed the study follow-up consisting of an intravascular ultrasound at baseline and at 12 months. RESULTS: There was no difference in the baseline characteristics and distribution of other medications. No significant differences were observed in primary endpoints, including changes in atheroma volume index (-12.65% vs. -8.51%, p=0.768) and percent atheroma volume (-4.36% vs. -9.98%, p=0.526), and in secondary endpoints including a change in neointimal volume index (7.84 vs. 4.94 mm3/mm, p=0.087). CONCLUSION: ω-3 PUFA had no definite additional effect on the regression of coronary atherosclerosis when added to statin in CAD patients undergoing PCI.
Atherosclerosis ; Coronary Artery Disease* ; Fatty Acids, Omega-3* ; Follow-Up Studies ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors* ; Percutaneous Coronary Intervention* ; Plaque, Atherosclerotic ; Stents ; Ultrasonography

PURPOSE: The objective of this study was to explore the relationship between the circulating lymphocyte level during preoperative chemoradiotherapy (CRT) and pathologic complete response (pCR) in locally advanced rectal cancer. MATERIALS AND METHODS: From May 2010 to May 2013, 52 patients treated with preoperative CRT followed by surgery, were analysed. Patients received conventional fractionated radiotherapy (50-54 Gy) with fluorouracil-based chemotherapy. Surgical resection was performed at 4 to 8 weeks after the completion of preoperative CRT. Absolute blood lymphocyte counts and their relative percentage in total white blood cell counts were obtained from complete blood count tests performed prior to and after 4, 8, and 12 weeks of CRT. We analysed the association between achieving pCR and change in blood lymphocyte level during CRT, as well as clinical parameters. RESULTS: Among 52 patients, 14 (26.9%) had evidence of pCR. Sustaining the blood lymphocyte count during CRT (lymphocyte count at 4 weeks/baseline lymphocyte count > 0.35; odds ratio, 8.33; p=0.02) and initial carcinoembryonic antigen < 4.4 ng/mL (odds ratio, 6.71; p=0.03) were significantly associated with pCR in multivariate analyses. CONCLUSION: Sustaining blood lymphocyte count during preoperative CRT was predictive for pCR in rectal cancer. Further studies are warranted to investigate the association between pathologic responses and circulating lymphocyte count with its subpopulation during preoperative CRT.
Blood Cell Count ; Carcinoembryonic Antigen ; Chemoradiotherapy* ; Drug Therapy ; Humans ; Leukocyte Count ; Lymphocyte Count* ; Lymphocytes* ; Multivariate Analysis ; Neoadjuvant Therapy ; Odds Ratio ; Polymerase Chain Reaction ; Radiotherapy ; Rectal Neoplasms*

PURPOSE: Adipose-derived stem cells (ADSCs) are known to be potentially effective in regeneration of damaged tissue. We aimed to assess the effectiveness of intracoronary administration of ADSCs in reducing the infarction area and improving function after acute transmural myocardial infarction (MI) in a porcine model. MATERIALS AND METHODS: ADSCs were obtained from each pig's abdominal subcutaneous fat tissue by simple liposuction. After 3 passages of 14-days culture, 2 million ADSCs were injected into the coronary artery 30 min after acute transmural MI. At baseline and 4 weeks after the ADSC injection, 99mTc methoxyisobutylisonitrile-single photon emission computed tomography (MIBISPECT) was performed to evaluate the left ventricular volume, left ventricular ejection fraction (LVEF; %), and perfusion defects as well as the myocardial salvage (%) and salvage index. At 4 weeks, each pig was sacrificed, and the heart was extracted and dissected. Gross and microscopic analyses with specific immunohistochemistry staining were then performed. RESULTS: Analysis showed improvement in the perfusion defect, but not in the LVEF in the ADSC group (n=14), compared with the control group (n=14) (perfusion defect, -13.0+/-10.0 vs. -2.6+/-12.0, p=0.019; LVEF, -8.0+/-15.4 vs. -15.9+/-14.8, p=0.181). There was a tendency of reducing left ventricular volume in ADSC group. The ADSCs identified by stromal cell-derived factor-1 (SDF-1) staining were well co-localized by von Willebrand factor and Troponin T staining. CONCLUSION: Intracoronary injection of cultured ADSCs improved myocardial perfusion in this porcine acute transmural MI model.
Adipose Tissue/cytology ; Animals ; Bone Marrow Cells/cytology/*metabolism ; Chemokine CXCL12 ; Coronary Vessels ; Female ; Heart/physiopathology ; Heart Ventricles ; *Mesenchymal Stromal Cells ; Myocardial Infarction/physiopathology/radionuclide imaging/*therapy ; *Stem Cell Transplantation ; Swine ; Technetium Tc 99m Sestamibi/*pharmacology ; Tomography, Emission-Computed, Single-Photon/*methods ; Troponin T ; *Ventricular Function, Left