Hanyang University Seoul Hospital

Recent randomized controlled trials (RCTs) regarding the outcomes of neoadjuvant chemotherapy for patients with resectable pancreatic cancer (PC) reported inconsistent results. As the survival rate of FOLFIRINOX was found to be superior to that of gemcitabine, interest in the efficacy of neoadjuvant chemotherapy with FOLFIRINOX for resectable PC is growing. In this study, we aimed to investigate the efficacy of neoadjuvant FOLFIRINOX in patients with resectable PC. This international (South Korea, Australia, and Taiwan), multicenter, phase 3, RCT will include 609 patients with resectable pancreatic ductal adenocarcinoma and ECOG performance 0–1. Resectable PC is defined as no arterial contact and no tumour contact with the superior mesenteric vein/portal vein or ≤ 180°contact without vein contour irregularity. Neoadjuvant FOLFIRINOX consisted of oxaliplatin (85 mg/m2), administered intravenously over 2 h, followed by leucovorin (400 mg/m2) over 2 h and irinotecan (180 mg/m2) over 90 min, administered concurrently. Subsequently, an intravenous bolus infusion of 5-FU (400 mg/m2) and a continuous infusion of 5-FU (2400 mg/m2) over 46 h, repeated every 2 weeks for 6 cycles. Adjuvant therapy with modified FOLFIRINOX (mFOLFIRINOX) included oxaliplatin (85 mg/m2), irinotecan (150 mg/m2), leucovorin (400 mg/m2), and fluorouracil (2400 mg/m2) over 46 h and repeated every 2 weeks, with six cycles in the neoadjuvant group and 12 cycles in the upfront surgery group. The primary endpoint is a two-year survival rate by intention-to-treat. Secondary outcomes are overall survival, disease-free survival, resection rate, R0 resection rate, lymph node negative rate, recurrence rate, response rate. When calculating with a significance level of 5% and a statistical power of 80%, 171 events (deaths) are needed. Considering the 5-year participant enrollment period and a minimum of a 2-year follow-up period, 518 patients were required to observe 171 events. A total of 609 patients were required when the dropout rate was calculated as 15%. The NeoFOL-R trial investigates the efficacy of perioperative versus adjuvant FOLFIRINOX for patients with resectable PC. The study is ongoing, starting in February 2024 in South Korea, Australia, and Taiwan. NCT 05529940. Registered in September 2022. KCT0008360 (Korean Clinical Trial Database). Registered in April 2022.

Active surveillance (AS) is recommended for low-risk papillary thyroid microcarcinoma (PTMC) in many guidelines. However, while its clinical application requires incorporation of patient values, implementing shared decision-making (SDM) in practice remains challenging. To generate reliable evidence, facilitate the integration of SDM into routine PTMC managements and improve patient satisfaction, this study developed a PTMC-specific SDM model (SM group) and aims to evaluate whether it improves patient-reported outcomes (PROs) compared to usual care (UC group) in patients with low-risk PTMC. This multicenter, parallel-group, cluster-randomized controlled trial will enroll 310 patients with low-risk PTMC across seven academic hospitals in Korea. Participants will be assigned to either the SM group (model) or the UC group (control) through cluster randomization of 26 clinicians, stratified by specialty and AS experience. The SM group will receive structured counseling using a newly developed PTMC-specific SDM model, supported by decision aids such as educational videos, web-based card news, and illustrated leaflets regarding disease-information and patients’ values. The UC group will receive standard counseling. The primary outcome is the Decisional Conflict Scale score. Secondary outcomes include satisfaction with decision-making process, decision regret, anxiety, and thyroid-specific quality of life. Data will be collected via the iCReaT v2.0 electronic Case Report Form, supplemented by electronic and paper-based PRO surveys. Assessments will be conducted at baseline, 1–4 weeks, and 6 months after the treatment decision.Trial RegistrationClinicalTrials.gov Identifier: NCT06730893

Abstract Background The risk of viral hepatitis may increase in patients with long-term inflammatory bowel disease (IBD) due to the increased frequency of procedures with a risk of infection, such as endoscopy, blood transfusion, and surgery 1,2. There are few studies on HAV, and the results regarding HCV infection have differed between studies. We investigated whether patients with IBD in Korea have an increased risk of hepatitis A virus (HAV) and hepatitis C virus (HCV) infections and sought to identify the risk factors for these infections. Methods This study used data from the Health Insurance Review and Assessment Service (HIRAS). We performed a nationwide population-based study using 2013-2021 data from the Korean National Health Insurance Claims Database. A total of 85,830 patients diagnosed with IBD (UC or CD) were enrolled between 2013 and 2021. We excluded patients who were prescribed only systemic corticosteroids, patients who had no history of prescriptions for IBD-related medications, patients whose diagnosis changed from UC to CD or vice versa, patients who had simultaneous diagnosis codes for UC and CD, and patients who were with viral hepatitis within 3 years prior to the index date. Patients with missing sex or age data were also excluded. A total of 43,513 patients, including 28,771 with UC and 14,742 with CD, were included in the study. We calculated the incidence rates and standardized incidence ratios (SIRs) of HAV and HCV infections in patients with IBD compared with the overall Korean population. Results A total of 43,513 patients were included in this study. A total of 317 cases of HAV were identified in 276,007 person-years, while 297 cases of HAV developed in the Korean general population. The SIR of HAV in the patients with IBD was 1.07 (95% Confidence Interval (CI), 0.96-1.19) and the increase of HAV infection in patients with IBD was not statistically significant. A total of 289 cases of HCV infection were identified in 276,538 person-years, while 242 cases of HCV infection developed in the Korean general population. The SIR of HCV in patients with IBD was 1.19 (95% CI, 1.06-1.34) and the increase of HCV infection in patients with Crohn’s disease (SIR 1.63; 95% CI, 1.31-2.04). Corticosteroid use was identified as a risk factor for HAV and HCV infections in patients with IBD. Conclusion HCV showed an increasing trend in Korean patients with IBD, especially those with Crohn’s disease. Corticosteroids use is a risk factor for hepatitis in patients with IBD.

IntroductionMixed pathology of Alzheimer’s disease (AD) and dementia with Lewy bodies (DLB) are frequently observed in patients with cognitive impairment, and complicate clinical diagnosis. We aimed to develop a classification model using 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) to improve diagnostic accuracy for these challenging cases.MethodsWe analyzed FDG-PET images from 277 participants who were categorized into AD, DLB, mixed disease, and healthy control (HC) groups. Deep learning-based classification models were trained on seven binary classification tasks and one multiclass classification task and subsequently integrated into an ensemble model to predict AD, DLB, mixed disease or HC groups.ResultsThe model achieved an AUROC of 0.73 (95% CI, 0.69–0.78) for AD, 0.90 (95% CI, 0.89–0.91) for DLB, 0.71 (95% CI, 0.66–0.75) for Mixed, and 0.87 (95% CI, 0.84–0.89) for HC.DiscussionThe model represents the state-of-the-art in automatic FDG-PET-based classification of AD, DLB, Mixed, and HC. This study highlights the utility of FDG-PET as a biomarker for differentiating AD, DLB, Mixed, and HC groups, resolving diagnostic challenges caused by overlapping clinical features.