Background: A novel botulinum toxin type A (Protoxin; Protox Inc.) has been developed. Objective: To evaluate the efficacy and safety of the newly developed Protoxin compared to the approved drug onabotulinumtoxinA (OBoNT) in moderate to severe glabellar lines. Methods: Adults with a glabellar line Facial Wrinkle Scale (FWS) score of 2 (moderate) or 3 (severe) were enrolled in the study. Subjects were randomized in a 1:1 ratio to receive either Protoxin or OBoNT. A total of 20 units of botulinum toxin was injected at five sites in the glabellar region (4 units at each site). FWS scores were assessed at baseline and at weeks 4, 8, 12, and 16 post-injection. The primary endpoint was the proportion of subjects at week 4 who had a reduction of 2 or more points in FWS and a final score of 0 (none) or 1 (mild). Results: A total of 274 subjects were randomized, of whom 78.1% were female. At week 4 post-treatment, the improvement rate of glabellar lines was 62.22% in the Protoxin group and 62.96% in the OBoNT group. The lower limit of the two-sided 95% confidence interval (−12.24%) exceeded the −15% margin, confirming the non-inferiority of the new drug. Safety profiles were comparable between the two groups. Conclusion Protoxin demonstrated efficacy and safety profiles comparable to those of OBoNT in the treatment of moderate to severe glabellar lines.

Background: As nationwide government-led whole-genome sequencing (WGS) projects progress, optimizing the clinical integration of large-scale WGS results is crucial. We explored how the initial analysis from Korea’s First WGS Pilot Study for Rare Diseases was applied in clinical practice, and then we reanalyzed the data comprehensively at Samsung Medical Center (SMC) Seoul, Korea. Methods: A prospective cohort study designed to collect WGS data under a Korean national initiative was conducted from August 2020 to December 2021. We focused on patients with rare diseases recruited from 16 university hospitals. The participants included 5,000 individuals (2,200 probands and 2,800 family members). The initial WGS data and diagnostic reference reports (from 682 probands and 484 family members), generated based on the First Korean WGS Pilot Study for Rare Diseases, were subsequently reanalyzed by SMC. Results: The initial analysis of the First Korean WGS Pilot Study data revealed a diagnostic rate of 17%. Upon receiving these results, the SMC conducted two rounds of reanalysis, increasing the diagnostic rate from 15% in the first analysis, to 18% in the second, and finally to 24% in the third (P = 1.6 × 10 −5 ). Key factors in improving the genetic diagnosis included increased detection of novel (likely) pathogenic variants (P = 1.0 × 10 −4 ), improved diagnostic rates with larger family recruitment (P = 0.004), and refined clinical information for more precise genotype–phenotype correlation analysis (40%). Conclusions Although national WGS projects lay a foundation for rare disease diagnosis, hospital-level reanalysis and multidisciplinary collaborations are crucial for optimizing diagnostic outcomes.

Background: The 2020 European Society of Cardiology (ESC) 0-hr/1-hr algorithm using high-sensitivity cardiac troponin I (hs-cTnI) for non-ST-segment elevation acute coronary syndrome (NSTE-ACS) aims at early diagnosis and shorter emergency department (ED) stays. While this algorithm has been well-established in controlled studies, real-world implementation remains challenging. We evaluated the algorithm’s clinical performance and risk stratification capability in patients with chest pain or discomfort. Methods: We measured hs-cTnI in 4,678 patients suspected of NSTE-ACS between August 2022 and July 2023, using an Atellica IM Analyzer (Siemens Healthineers, Erlangen, Germany). We categorized patients into rule-in, observe, or rule-out groups according to the algorithm and assessed its diagnostic performance for NSTE-ACS. The final diagnosis of NSTE-ACS was adjudicated by two independent physicians. Additionally, we evaluated 30-day all-cause mortality, hazard risk, and ED length of stay across the three groups. Results: The algorithm categorized 3,408 (72.9%), 573 (12.2%), and 697 (14.9%) patients into the rule-out, observe, and rule-in groups, respectively. Among 90 patients diagnosed as having NSTE-ACS, none were falsely categorized into the rule-out group. Survival analysis revealed significant differences (P < 0.001), with Cox hazard ratios of 2.38 (95% confidence interval: 1.20–4.71) and 6.39 (3.45–11.86) in the observe and rule-in groups, respectively. ED stays shortened in the order of rule-out, observe, and rule-in groups (P < 0.001). Conclusions The 2020 ESC 0-hr/1-hr algorithm demonstrates excellent diagnostic accuracy without false rule-outs and effective risk stratification, and contributes to efficient ED throughput, supporting its clinical utility in real-world emergency settings.

Background: Fusion genes are major drivers of acute leukemia. Conventional diagnostics are limited in detecting the diverse fusions included in recently updated acute leukemia classifications. We evaluated the fusion detection performance of RNA sequencing (RNAseq) compared with that of conventional diagnostics in patients with acute leukemia. Methods: We retrospectively obtained the data of 101 patients with acute leukemia who underwent conventional diagnostics (i.e., karyotyping, FISH, or multiplex reverse transcription PCR) at diagnosis at Samsung Medical Center, Seoul, Korea, between September 2022 and September 2023. Whole RNA-seq was performed using the Illumina Stranded mRNA Prep kit (Illumina, San Diego, CA, USA). The concordance, sensitivity, and specificity of RNA-seq for fusion gene detection were compared with those of conventional diagnostics. Results: RNA-seq helped identify 52 fusion genes in 51 (50.5%) of 101 patients, with detection rates of 40.7%, 70.3%, 37.5%, and 50% in acute myeloid leukemia, B-cell acute lymphoblastic leukemia, T-cell acute lymphoblastic leukemia, and mixed-phenotype acute leukemia, respectively. RNA-seq showed 83.3% sensitivity and 80.8% concordance with conventional diagnostics; it missed eight fusions, likely because of low transcript abundance or enhancer hijacking. RNA-seq also helped clarify three previously unspecified rearrangements and detected 12 fusions (21.4%) in 56 cases that tested negative with conventional diagnostics, including four novel (KMT2A::THAP12 , RUNX1::PRPF19 , MLLT10::UBE2L6, and FUS::ZNF362) and three rare (HNRNPH1::ERG, RUNX1::USP42, and ETV6::NCOA2) fusions. Conclusions This was the first study to evaluate the performance of whole RNA-seq in fusion detection in patients with acute leukemia in Korea. Incorporating RNA-seq into diagnostic workflows may facilitate earlier and more precise therapeutic decisions and improve prognostic assessment in patients with acute leukemia.

Objective: This study aimed to evaluate the feasibility, safety, and oncologic outcomes of irreversible electroporation (IRE) using a clustered electrode in patients with locally advanced pancreatic cancer (LAPC). Materials and Methods: In this single-center prospective cohort study, 13 patients with LAPC (median age, 60 years; range, 48–78 years) underwent clustered electrode IRE between September 2022 and September 2024. Patient characteristics, procedural details, and clinical outcomes were recorded. Endpoints included technical success, procedure-related complications, overall survival (OS), and progression-free survival (PFS). Results: Tumors were located in the pancreatic head in four patients (30.8%) and in the body/tail in nine (69.2%). The median tumor size was 2.4 cm (1.5–4.0 cm), and vascular invasion was present in all patients. Technical success was achieved in all patients. Intraoperative IRE was performed in 11 (84.6%) patients, and 2 (15.4%) patients underwent percutaneous IRE. Gastrointestinal bleeding events as major complications occurred in two patients (15.4%) and, both were successfully controlled by embolization. No 60-day mortality was observed. At a median follow-up of 24.5 months (range, 9.9–33.4 months) after IRE, median OS and PFS from IRE were 20.1 and 14.5 months, respectively. Conclusion IRE using clustered electrodes for LAPC appears to be a feasible therapeutic approach, offering reliable technical success and acceptable safety. Survival outcomes are encouraging; however, larger, controlled studies are required.

Background: Postoperative liver regeneration is essential for maintaining hepatic function. This study evaluated the rate, determinants, and volumetric patterns of early liver regeneration after hemihepatectomy. Methods: A retrospective review was conducted of 50 patients who underwent right or left hemihepatectomy between April 2019 and March 2025. Liver and spleen volumes (SV) were assessed preoperatively, at postoperative day (POD) 1 week, and at POD 3 months. Early liver regeneration rate (LRR) was defined as the percentage increase in remnant liver volume at POD 1 week relative to the preoperative future liver remnant (FLR), and patients were categorized into low (<50%) and high (≥50%) LRR groups. Clinical, biochemical, and volumetric variables were compared, and predictors of regeneration were identified using multivariable analyses. Regeneration patterns were also examined according to whether the FLR/standard liver volume (SLV) ratio was <50% or ≥50%. Results: FLR/SLV was the strongest independent predictor of rapid early liver regeneration (p<0.001). Remnants with FLR/SLV <50% exhibited rapid and sustained regeneration, whereas those with FLR/SLV ≥50% showed slower regrowth that plateaued after reaching approximately 90% of SLV. SV increased at POD 1 week in all patients; however, only the FLR/SLV ≥50% group showed a reduction by POD 3 months, whereas the <50% group maintained elevated volumes. Conclusions FLR/SLV reliably predicts early postoperative liver regeneration. Smaller remnants regenerate more rapidly, whereas persistent splenic enlargement suggests a sustained portal hemodynamic burden. Combined evaluation of FLR/SLV and SV may enhance perioperative risk assessment and surgical planning.

Purpose: Distant metastasis of breast cancer significantly affects the prognosis. Serum markers such as CEA and cancer antigen (CA) 15-3 are used for surveillance. However, the nonspecificity and nonmalignant elevation of CEA limit its absolute value in predicting metastatic recurrence. We reevaluated the clinical value of CEA kinetics in predicting metastatic recurrence in breast cancer. Methods: In this multicenter retrospective cohort study, we utilized electronic medical record data from eight institutions (2008–2023), including 4,872 surgically treated patients with invasive breast cancer. Novel CEA kinetic indices were defined.Predictive capabilities were assessed using logistic regression, Kaplan-Meier survival curves, and Cox proportional hazards models. Results: CEA velocity (vCEA) and last-interval vCEA (vCEA-L) showed higher accuracy and sensitivity in predicting distant metastasis than absolute CEA indices. All tumor marker indices were independent predictors; vCEA, vCEA-L, and maximum vCEA (vCEAmax) showed the highest association. In the 5-year distant disease-free survival analysis of patients, vCEA showed the most significant difference based on whether its cutoff value was exceeded (84.1% vs. 47.2%) (P < 0.001).Cox analysis showed that vCEA was the strongest predictor (hazard ratio, 4.509; P < 0.001). vCEAmax remained prognostic even when CEAmax was below its cutoff value. Conclusion Analysis of dynamic CEA changes, particularly velocity-based indices, offers superior predictive power than the static-based CEA indices for metastatic recurrence in breast cancer. These kinetic markers enhance prognostic accuracy when combined with CA 15-3. Future research should integrate these markers with imaging, liquid biopsy, and artificial intelligence for personalized follow-up.

Purpose: The aim of this study is to compare the detection ability of quality of life (QoL) changes and responsiveness of the KOrean QUality of life in Stomach cancer patients Study group (KOQUSS)-40 and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ). Materials and Methods: A multicenter prospective observational study was conducted to evaluate QoL changes after various gastrectomies between January 2021 and April 2022. Participants were instructed to complete the KOQUSS-40 and EORTC QLQ-C30/STO22 preoperatively and at 1, 3, 6, and 12 months postoperatively. QoL changes over time and QoL responsiveness were assessed for each questionnaire. Results: Data from 491 patients who underwent curative gastrectomy for gastric cancer at 22 institutions were analyzed. The summary scores of the KOQUSS-40 and EORTC QLQ-STO22 showed significant differences between the total and proximal gastrectomy groups (p=0.044 and p=0.038, respectively), but no difference was observed for the EORTC QLQ-C30. Dysphagia on the KOQUSS-40 was significantly different between the total and proximal gastrectomy groups (p=0.031); however, dysphagia on the EORTC QLQ-STO22 did not differ. The responsiveness of the KOQUSS-40 was similar to that of the EORTC QLQ in patients who experienced ≥ 10% body weight loss, but approximately 10% less in patients receiving adjuvant chemotherapy than the EORTC QLQ. Conclusion KOQUSS-40 has several advantages over EORTC QLQ-C30/STO22 when comparing QoL between the total and proximal gastrectomy groups. The findings provide information for researchers investigating the QoL of patients who have undergone curative gastrectomy for gastric cancer.

Background: Blunt trauma is a major cause of mortality in the working-age population. Patients who develop hypotension shortly after an injury are at a particularly high risk of death. This nationwide study aimed to identify the factors associated with mortality in patients with hypotension after blunt trauma. Methods: We analyzed nationwide data from the National Emergency Department Information System for patients aged 15 to 69 years who presented to regional or higher-level emergency medical centers between 2019 and 2023 after blunt trauma. Patients with an initial systolic blood pressure ≤90 mmHg and classified as high acuity (Korean Triage and Acuity Scale ≤3) were included. Results: Among the 2,713,014 trauma cases, 25,107 met the inclusion criteria, and 16,823 (67.0%) were male. Traffic accidents were the most common reason for injury (38.8%). Mortality was significantly associated with brain injury (hazard ratio, 1.906; 95% confidence interval, 1.661–2.186). The median time from emergency department visit to death was 45.0 hours (interquartile range [IQR], 9.0–188.0 hours), and non-survivors had a median hospital stay of 2.0 days (IQR, 0.0–8.0 days). Conclusion Most deaths following blunt trauma occurred within 48 hours of injury, with brain injury being strongly associated with mortality. However, the contribution of other injured body regions may not have been fully captured. These findings underscore the importance of early recognition and comprehensive management of patients with hypotensive blunt trauma.