Background/Aims Endoscopic retrograde cholangiopancreatography with stone extraction is the standard treatment for common bile duct (CBD) stones. However, few studies have evaluated medical strategies to reduce CBD stone recurrence after endoscopic clearance. We performed a prospective, multicenter, randomized pilot trial to explore the potential effect of a terpene preparation in this setting. Methods Thirty patients who had undergone endoscopic management of CBD stones within 4 weeks were enrolled from four Korean university hospitals and randomized 1:1 to receive either the terpene preparation (200 mg three times daily for 24 weeks) or no medication. The primary outcome was the recurrence of CBD stones at 48 weeks confirmed by imaging. The analysis was performed according to the per-protocol principle. Results Twenty-one patients (9 in the treatment group and 12 in the control group) completed the study; attrition was 40.0% and 20.0%, respectively. Baseline characteristics were comparable between the groups, although the maximal CBD diameter was numerically greater in the treatment group (12.3 mm vs 9.3 mm; p=0.074). No CBD stone recurrence occurred in the treatment group, whereas recurrence occurred in two patients in the control group. The absolute risk difference was -16.7% (95% confidence interval, -37.8% to 4.4%; Fisher exact, p=0.486). Conclusions In this pilot trial, no CBD stone recurrence occurred in the treatment group despite a numerically higher baseline anatomic risk, whereas two of 12 control-group patients experienced recurrence. The trial was not powered to detect a treatment effect; therefore, no conclusions regarding efficacy can be drawn. The primary contribution is to inform the feasibility and design of a confirmatory trial. (cris.nih.go.kr, KCT0002289).
Background/Aims Most data on adverse events (AEs) following gastric endoscopic submucosal dissection (ESD) originate from high-volume expert centers, limiting their generalizability to routine clinical practice. Population-level claims-based evidence on AEs after gastric ESD remains limited, although such data cannot fully account for lesion- and procedure-specific risk factors. Methods We conducted a nationwide, retrospective cohort study using claims data from the Korean Health Insurance Review and Assessment Service. All patients who underwent ESD for gastric neoplastic lesions between 2013 and 2017 were included. Claims-defined AEs-including bleeding, perforation, pneumonia, and intensive care unit (ICU) admission within 30 days-were assessed, along with subsequent gastric surgery within 90 days. Multivariable logistic regression was used to identify factors associated with each outcome. Results A total of 83,871 gastric ESD procedures were performed in 76,181 patients. The incidence of bleeding was 16.6%, whereas perforation (0.17%), pneumonia (0.65%), and ICU admission (0.94%) were uncommon. Older age was associated with a lower risk of bleeding but a higher risk of pneumonia and ICU admission, particularly among patients aged ≥80 years. Among the antithrombotic agents included in the analysis, warfarin was associated with bleeding and clopidogrel was associated with ICU admission. Procedures performed at general hospitals were associated with higher risks of multiple AEs compared with those performed at tertiary centers. Overall, 3.9% of patients underwent additional gastric surgery, almost exclusively among those with gastric cancer. Conclusions In this nationwide population-based claims study, claims-defined AEs after standard-indication gastric ESD were associated with patient-level and institution-level variables available in administrative data (cris.nih.go.kr, KCT0011604).
