• Journal of Korean Neurosurgical Society
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• v.47 no.2
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• pp.112-118
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• 2010

Objective : There have been no clinical studies regarding the epidemiology and treatment outcome for unruptured intracranial aneurysm (UIA) in South Korea yet. Thus, The Korean Society of Cerebrovascular Surgery (KSCVS) decided to evaluate the clinical and epidemiological characteristics, and outcome of the treatment of UIA in 2006, using the nationwide multicenter survey in South Korea. Methods : A total of 1,696 cases were enrolled retrospectively over one year at 48 hospitals. The following data were obtained from all patients : age, sex, presence of symptoms, location and size of the aneurysm, treatment modality, presence of risk factors for stroke, and the postoperative 3D-day morbidity and mortality. Results : The demographic data showed female predominance and peak age of seventh and sixth decades. Supraclinoid internal carotid artery was the most common site of aneurysms with a mean size of 5.6 mm. Eight-hundred-forty-six patients (49.9%) were treated with clipping, 824 (48.6%) with coiling, and 26 with combined method. The choice of the treatment modalities was related to hospital (p=0.000), age (p=0.000), presence of symptom (p=0.003), and location of aneurysm (p=0.000). The overall 30-day morbidity and mortality were 7.4% and 0.3%, respectively. The 30-day mortality was 0.4% for clipping and 0.2% for coiling, and morbidity was 8.4% for clipping and 6.3% for coiling. Age (p=0.010), presence of symptoms (p=0.034), size (p=0.000) of aneurysm, and diabetes mellitus (p=0.000) were significant prognostic factors, while treatment modality was not. Conclusion : This first nation-wide multicenter survey on UIAs demonstrates the epidemiological and clinical characteristics, outcome and the prognostic factors of the treatment of UIAs in South Korea. The 30-day postoperative outcome for UIAs seems to be reasonable morbidity and mortality in South Korea.

• Journal of Gastric Cancer
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• v.19 no.2
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• pp.157-164
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• 2019

Purpose: Although standard radical gastrectomy is recommended after noncurative resection of endoscopic submucosal dissection (ESD) for early gastric cancer in most cases, residual tumor and lymph node metastasis have not been identified after surgery. The aim of this study is to evaluate the feasibility of sentinel node navigation surgery after noncurative ESD. Materials and Methods: This trial is an investigator-initiated, multicenter prospective phase II trial. Patients who underwent ESD for clinical stage T1N0M0 gastric cancer with noncurative resections were eligible. Qualified investigators who completed the prior phase III trial (SENORITA 1) are exclusively allowed to participate. In this study, 2 detection methods will be used: 1) intraoperative endoscopic submucosal injection of dual tracer, including radioisotope and indocyanine green (ICG) with sentinel basins detected using gamma-probe; 2) endoscopic injection of ICG, with sentinel basins detected using a fluorescence imaging system. Standard laparoscopic gastrectomy with lymphadenectomy will be performed. Sample size is calculated based on the inferior confidence interval of the detection rate of 95%, and the calculated accrual is 237 patients. The primary endpoint is detection rate, and the secondary endpoints are sensitivity and postoperative complications. Conclusions: This study is expected to clarify the feasibility of laparoscopic sentinel basin dissection after noncurative ESD. If the feasibility is demonstrated, a multicenter phase III trial will be initiated to compare laparoscopic sentinel node navigation surgery versus laparoscopic standard gastrectomy in early gastric cancer after endoscopic resection.

• Asian Pacific Journal of Cancer Prevention
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• v.16 no.17
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• pp.7441-7447
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• 2015

Objective: This study evaluated the safety and objective response of combining $^{131}I$-labeled-metuximab (Licartin) with transarterial chemoembolization (TACE) in the treatment of unresectable hepatocellular carcinoma (HCC). Materials and Methods: In a multicenter open-label clinical trial, 341 enrolled patients with stage III/IV HCC according to TNM criteria were nonrandomly assigned to a trial group (n=167) and a control group (n=174), undergoing TACE following hepatic intra-arterial injection of licartin or TACE alone from July 2007 to July 2009. Radiopharmaceutical distribution was evaluated. The primary endpoint was overall survival; secondary endpoints included time-to-progression (TTP), toxicity and adverse events (AEs). Results: The radiobiological distribution demonstrated better localization of licartin in liver tumors than other tissues (P<0.01). The organ absorbed doses to liver and red marrow were $3.19{\pm}1.01Gy$ and $0.55{\pm}0.22Gy$, respectively. The 1-year survival rate was significantly higher [79.47% vs. 65.59%, hazard ratio (HR), 0.598, P=0.041] and TTP significantly improved ($6.82{\pm}1.28$ vs. $4.7{\pm}1.14months$, P=0.037) compared with the control group. Patients at stage III achieved more benefit of one year survival than stage IV in the trial group (86.9% vs. 53.8%, P<0.001). There were significant different toxicities in leukocytopenia, thrombocytopenia and increased total bilirubin level [P<0.001, P=0.013, P<0.01, relative risk (RR) 1.63, 1.33, 1.43], but no differences in severe AEs of upper GI hemorrhage and severe liver dysfunction between the groups (5.39% vs. 2.3%, P=0.136). Conclusions: Owing to excellent tumor-targeting, promised efficacy and favourable toxicity profile, the novel combination therapy of licartin and TACE could be applied in patients with unresectable HCC.

• Pediatric Gastroenterology, Hepatology & Nutrition
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• v.25 no.3
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• pp.218-227
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• 2022

Purpose: To analyze the characteristics of pediatric inflammatory bowel disease (IBD) over the past three decades in Argentina and determine if there are differences between the first two decades and the past decade. Methods: We conducted a retrospective multicenter analytical study in children with IBD between 0 and 18 years of age diagnosed between 1987 and 2017 in three tertiary health centers in Argentina. The evaluation included clinical characterization, endoscopy, histology, and imaging data together with therapeutic strategies. The patients were divided into two groups: Group 1, diagnosed between 1987 and 2007, and Group 2, diagnosed between 2008 and 2017. Results: Of the 756 patients included, 409 (54%) had ulcerative colitis (UC), 250 (33%) had Crohn's disease (CD), and 97 (13%) had IBD-unclassified (IBD-U). The positive family history was 3.8%, which was more frequent among children under two years of age (6.7%). There were no significant differences in clinical presentation and extraintestinal manifestations between periods, with hepatic manifestations being the most frequent. In the last decade, we found an upward trend in CD, a downward trend in UC/IBD-U, even after adjustment for socioeconomic status, and a decrease of 50% in surgical treatments coinciding with the advent of biological therapy. Conclusion: This is the first multicenter cohort study in a Latin American country to describe clinical, endoscopic, and therapeutic data across the past 30-year period. Although CD was responsible for the overall increase in incidence, UC was still prevalent in this region.

• Journal of Trauma and Injury
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• v.37 no.2
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• pp.140-146
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• 2024

Purpose: Despite the high incidence of abdominal stab injuries, the rate of nontherapeutic laparotomies and the predictors of therapeutic laparotomies have rarely been studied in low-income settings. Methods: This multicenter retrospective study involved three of the largest academic medical centers in central Ethiopia. All patients who sustained an anterior abdominal stab injury and underwent exploratory laparotomy, regardless of the intraoperative findings, were included over the 3-year course of the study. Results: Of the 117 patients who underwent exploratory laparotomy, 35 patients (29.9%) underwent nontherapeutic laparotomies. Three factors predicted therapeutic laparotomy: hollow viscus evisceration (adjusted odds ratio [AOR], 5.77; 95% confidence interval [CI], 1.16-28.64; P=0.032), localized and generalized peritonitis (AOR, 4.77; 95% CI, 1.90-11.93; P=0.001), and white blood cell count ≥11,500/mm³ (AOR, 2.77; 95% CI, 1.002-7.650; P=0.049). The overall positive predictive value of the therapeutic predictors was 80.2%, while the negative predictive value of all predictor-negative patients was 58.1%. The predictors would have prevented 51.4% of the nontherapeutic laparotomies. Conclusions: Close to one-third of the patients had a nontherapeutic laparotomy. The clinical predictors of therapeutic laparotomy were shown to have a high positive predictive value despite a lower negative predictive value. Further prospective studies that involve all patients who sustain anterior abdominal stab injuries are needed to potentially improve on the negative predictive value of the predictors suggested by our study.

• The Journal of KAIRB
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• v.5 no.1
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• pp.14-20
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• 2023

Purpose: To obtain fundamental data on selection tools for an internal audit and develop a new guideline. We scored the indicated points from the internal audit, identified the research progress and problems that occurred, and confirmed the validity of the risk factors involved. Methods: Of the 63 internal audits conducted by Keimyung University Dongsan Hospital from 2014 to 2021, we analyzed 55 clinical trials with an inspection checklist. We excluded 8 that failed to transfer data and refused to comply with the internal audit. The statistical summary of the collected data was verified and interpreted by using frequency analysis and a chi-square test. Result: Of total 55 cases included in the internal audit, sponsor-initiated trial (SIT) was 63.6% (vs. investigator-initiated trial [IIT]), clinical trial for investigational drug was 71.0% (vs. nonclinical or clinical trial for investigational device), domestic multicenter trial was 60.0% (vs. single center or multinational multicenter trial), and trial requisition for MFDS approval was 69.1% (vs. exception for MFDS approval). The 10 areas of the clinical trial inspection checklist (reports, protection of subjects, compliance with protocols, records, management of investigational drug and/or device, delegation of duties, qualification of investigators, management of specimen, contract-agreement and approval of protocols, and preservation of recorded documents) were weighted between 2 to 5 points. The average of the total points was 16.09±13.2 and 20 clinical trials were above the average. As a result of comparing the average of the total points weighted by year, the highest score was in 2020. The 4 factors that play significant roles in determining the internal quality were (1) principal subjects that initiated the clinical trials (p=0.049), (2) type (p=0.003), (3) phase of clinical trials (p=0.024), and (4) number of registered subjects reported at the time of continuing deliberation (p=0.019). Of the 10 areas of the clinical trial inspection checklist, 'record' was the most inappropriate and insufficient. We found more indicated points; the quality of performance declined in IIT, nonclinical trials, and other clinical trials that were not in phase I1-IV4, and the study of more than 30 registered subjects at the time of continuing review. Conclusion: If an institution has an internal audit selection tool that reflects the aforementioned risk factors, it will be possible to effectively manage high-risk studies; thereby, contributing to an efficient internal audit and improving the quality of clinical trials.

• Korean Circulation Journal
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• v.52 no.6
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• pp.444-454
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• 2022

Background and Objectives: The aim of this study was to demonstrate the efficacy and safety of treatment with drug-coated balloon (DCB) in a large real-world population. Methods: Patients treated with DCBs were included in a multicenter observational registry that enrolled patients from 18 hospitals in Korea between January 2009 and December 2017. The primary outcome was target lesion failure (TLF) defined as a composite of cardiovascular death, target vessel myocardial infarction, and clinically indicated target lesion revascularization at 12 months. Results: The study included 2,509 patients with 2,666 DCB-treated coronary artery lesions (1,688 [63.3%] with in-stent restenosis [ISR] lesions vs. 978 [36.7%] with de novo lesions). The mean age with standard deviation was 65.7±11.3 years; 65.7% of the patients were men. At 12 months, the primary outcome, TLF, occurred in 179 (6.7%), 151 (8.9%), 28 (2.9%) patients among the total, ISR, and de novo lesion populations, respectively. A history of hypertension, diabetes, acute coronary syndrome, previous coronary artery bypass graft, reduced left ventricular ejection fraction, B2C lesion and ISR lesion were independent predictors of 12 months TLF in the overall study population. Conclusions: This large multicenter DCB registry study revealed the favorable clinical outcome of DCB treatment in real-world practice in patient with ISR lesion as well as small de novo coronary lesion.

• Journal of Gastric Cancer
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• v.12 no.1
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• pp.13-17
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• 2012

Laparoscopic gastrectomy was begun in 1995 in Korea. But, there was 4 years gap to reactivate in 1999. High incidence of gastric cancer and increasing proportion of early cancer through national screening program along with huge effort and enthusiasm of laparoscopic gastric surgeon, and active academic exchange with Japanese doctors contributed development of laparoscopic gastrectomy in Korea. Study group activity of Korean Laparoscopic Gastrointestinal Surgery Study (KLASS) group and Collaborative Action for Gastric Cancer (COACT) group were paramount to evoke large scale multicenter clinical study and various well performed clinical studies. This review encompasses mainly international publications about this area so far in Korea.

• Journal of Hospice and Palliative Care
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• v.24 no.1
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• pp.66-68
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• 2021

The World Health Organization (WHO) declared the coronavirus disease 2019 (COVID-19) outbreak to be a pandemic on March 12, 2020. In Korea, there have been 24,027 confirmed cases of COVID-19 and 420 deaths as of October 3, 2020. The clinical spectrum of COVID-19 ranges from asymptomatic infection to death. Cancer care in this pandemic has radically changed. The literature was reviewed. The COVID-19 pandemic has made it urgently necessary to profoundly re-organize cancer patients' care without compromising cancer outcomes. Several important questions in regard to COVID-19 infection in cancer patients have emerged. Are patients with cancer at a higher risk of COVID-19 infection? Are they at an increased risk of mortality and severe illness when infected with COVID-19? Does anticancer treatment affect the course of COVID-19? Based on the existing research, cancer patients with immunosuppression are vulnerable to COVID-19 infection, and cancer patients are more likely to experience severe COVID-19. However, chemotherapy and major surgery do not seem to be predictors of hospitalization or severe disease. Korean background data on patients with cancer and COVID-19 are lacking. Prospective multicenter studies on the outcomes of patients with cancer and COVID-19 should be conducted.

• Korean Journal of Radiology
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• v.23 no.7
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• pp.763-772
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• 2022

Objective: Preoperative differential diagnosis of follicular-patterned lesions is challenging. This multicenter cohort study investigated the clinicoradiological characteristics relevant to the differential diagnosis of such lesions. Materials and Methods: From June to September 2015, 4787 thyroid nodules (≥ 1.0 cm) with a final diagnosis of benign follicular nodule (BN, n = 4461), follicular adenoma (FA, n = 136), follicular carcinoma (FC, n = 62), or follicular variant of papillary thyroid carcinoma (FVPTC, n = 128) collected from 26 institutions were analyzed. The clinicoradiological characteristics of the lesions were compared among the different histological types using multivariable logistic regression analyses. The relative importance of the characteristics that distinguished histological types was determined using a random forest algorithm. Results: Compared to BN (as the control group), the distinguishing features of follicular-patterned neoplasms (FA, FC, and FVPTC) were patient's age (odds ratio [OR], 0.969 per 1-year increase), lesion diameter (OR, 1.054 per 1-mm increase), presence of solid composition (OR, 2.255), presence of hypoechogenicity (OR, 2.181), and presence of halo (OR, 1.761) (all p < 0.05). Compared to FA (as the control), FC differed with respect to lesion diameter (OR, 1.040 per 1-mm increase) and rim calcifications (OR, 17.054), while FVPTC differed with respect to patient age (OR, 0.966 per 1-year increase), lesion diameter (OR, 0.975 per 1-mm increase), macrocalcifications (OR, 3.647), and non-smooth margins (OR, 2.538) (all p < 0.05). The five important features for the differential diagnosis of follicular-patterned neoplasms (FA, FC, and FVPTC) from BN are maximal lesion diameter, composition, echogenicity, orientation, and patient's age. The most important features distinguishing FC and FVPTC from FA are rim calcifications and macrocalcifications, respectively. Conclusion: Although follicular-patterned lesions have overlapping clinical and radiological features, the distinguishing features identified in our large clinical cohort may provide valuable information for preoperative distinction between them and decision-making regarding their management.