Background: s/Aims: Reported incidence of extrahepatic bile duct cancer is higher in Asians than in Western populations. Korea, in particular, is one of the countries with the highest incidence rates of extrahepatic bile duct cancer in the world. Although research and innovative therapeutic modalities for extrahepatic bile duct cancer are emerging, clinical guidelines are currently unavailable in Korea. The Korean Society of Hepato-Biliary-Pancreatic Surgery in collaboration with related societies (Korean Pancreatic and Biliary Surgery Society, Korean Society of Abdominal Radiology, Korean Society of Medical Oncology, Korean Society of Radiation Oncology, Korean Society of Pathologists, and Korean Society of Nuclear Medicine) decided to establish clinical guideline for extrahepatic bile duct cancer in June 2021. Methods: Contents of the guidelines were developed through subgroup meetings for each key question and a preliminary draft was finalized through a Clinical Guidelines Committee workshop. Results: In November 2021, the finalized draft was presented for public scrutiny during a formal hearing. Conclusions The extrahepatic guideline committee believed that this guideline could be helpful in the treatment of patients.

Background: & Objectives: Fixed-dose combinations (FDCs) offer advantages in adherence and cost-effectiveness compared to free combinations (FCs), but they can also complicate the prescribing process, potentially leading to therapeutic duplication (TD). This study aimed to identify the prescribing patterns of FDCs for dyslipidemia and investigate their associated risk of TD. Methods: This was a retrospective cohort study involving drugs that included statins, using Health Insurance Review & Assessment ServiceNational Patient Sample (HIRA-NPS) data from 2018. The unit of analysis was a prescription claim. The primary outcome was TD.The risk ratio of TD was calculated and adjusted for patient, prescriber, and the number of cardiovascular drugs prescribed using a multivariable Poisson model. Results: Our study included 252,797 FDC prescriptions and 515,666 FC prescriptions. Of the FDC group, 46.52% were male patients and 56.21% were aged 41 to 65. Ezetimibe was included in 71.61% of the FDC group, but only 0.25% of the FC group. TD occurred in 0.18% of the FDC group, and the adjusted risk ratio of TD in FDC prescriptions compared to FC was 6. 44 (95% CI 5. 30-7. 82). Conclusions Prescribing FDCs for dyslipidemia was associated with a higher risk of TD compared to free combinations. Despite the relatively low absolute prevalence of TD, the findings underline the necessity for strategies to mitigate this risk when prescribing FDCs for dyslipidemia. Our study suggests the potential utility of Clinical Decision Support Systems and standardizing nomenclature in reducing medication errors, providing valuable insights for clinical practice and future research.

Background: Swallowing of foreign bodies (FBs) is the most common indication of therapeutic endoscopy in children. Endoscopic removal may be necessary depending on the type of FB, age of the child, and location of the FB. We attempted to analyze the characteristics of each device used for the endoscopic removal of FBs in children. Methods: Medical records of the patient’s age, sex, weight, type, location, size, shape, type of device used for endoscopic removal, and endoscopic time were retrospectively collected. Results: A total of 424 FB removal procedures were analyzed. The average age of the patients at the time of FB removal was 4.1 ± 3.7 years. Coins were the most common FBs (192, 45.3%). The most common locations of the FBs were the esophagus (45.7%) and the stomach (48.3%), respectively. For a total of 371 cases, forceps were used in 96 cases (25.9%) for esophageal FBs and in 25 cases for gastric FBs (6.7%), while nets were used in 250 cases (67.4%) for gastric FBs retrieval; the average durations of the procedures were 7.2 ± 7.4 minutes, 8.5 ± 7.2 minutes, and 5.7 ± 7.3 minutes, respectively (P = 0.003). The procedure time was significantly shorter, in the group of patients with low body weights, when nets were used than when forceps were used to remove gastric FBs (P = 0.001). Conclusion The endoscopic procedure duration, in low-weight children, was shorter when retrieval nets were used than that with forceps.

Purpose: We report a case of post-pterygium excisional Pseudallescheria boydii (P. boydii) necrotizing scleritis successfully treated with multi-antifungal agents.Case summary: A 73-year-old female with a history of pterygium excision 6 years prior was referred to our institute because of worsening scleritis in the left eye during high-dose, 2-week steroid treatment. On the initial visit, an oval ulcer was observed in the temporal sclera adjacent to the limbus. All steroids were stopped and 1% voriconazole, 5% natamycin, 2.5% vancomycin, and 5% ceftazidime eyedrops were applied every hour and oral voriconazole 200 mg prescribed once a day, but the scleral necrosis continued to worsen. On day 10, the filamentous fungus P. boydii was isolated; 0.5% caspofungin eyedrops were added and the topical voriconazole concentration increased to 2%. Six weeks later, despite epithelization over the scleral necrosis, choroidal detachment developed. The antifungal treatment was continued and a dispersive, ophthalmic viscosurgical device inserted in the anterior chamber. At 14 weeks of treatment, the scleral necrosis was completely epithelialized and the choroidal detachment had disappeared. Conclusions When encountering a case of P. boydii-caused necrotizing scleritis developing after pterygium excision surgery, long-term intensive treatment with several antifungal agents must be considered.

Purpose: To determine whether the prognostic impact of lymph node ratio (LNR), defined as the ratio between the number of positive lymph nodes and removed lymph nodes, differs between open and minimally invasive surgical approaches for radical hysterectomy (RH) in node-positive, early-stage cervical cancer. Materials and Methods: We retrospectively identified 2009 International Federation of Gynecology and Obstetrics stage IB1-IIA2 patients who underwent primary type C RH between 2010 and 2018. Among them, only those with pathologically proven lymph node metastases who received adjuvant radiation therapy were included. The prognostic significance of LNR was investigated according to open surgery and minimally invasive surgery (MIS). Results: In total, 55 patients were included. The median LNR (%) was 9.524 (range, 2.083–62.500). Based on receiver operating characteristic curve analysis, the cut-off value for LNR (%) was determined as 8.831. Overall, patients with high LNR (≥8.831%;n=29) showed worse disease-free survival (DFS) than those with low LNR (<8.831%, n=26) (p=0.027), whereas no difference in overall survival was observed. Multivariate analyses adjusting for clinicopathologic factors revealed that DFS was adversely affected by both MIS [adjusted hazard ratio (HR), 8.132; p=0.038] and high LNR (adjusted HR, 10.837; p=0.045). In a subgroup of open surgery cases, LNR was not associated with disease recurrence. However, in a subgroup of MIS cases, high LNR was identified as an independent poor prognostic factor for DFS (adjusted HR, 14.578; p=0.034). Conclusion In patients with node-positive, early-stage cervical cancer, high LNR was associated with a significantly higher disease recurrence rate. This relationship was further consolidated among patients who received MIS RH.

Objective: To describe patterns of spontaneous reporting on adverse events following immunization (AEFIs) using the human papilloma virus (HPV) vaccine according to the Brighton Collaboration (BC) criteria. Methods: We used the Korea Adverse Event Reporting System (KAERS) database including vaccinations between 2008 and 2017. To apply BC criteria, we classified 58 BC AEFIs into World Health Organization Adverse Reaction Terminology (WHO-ART) codes. We applied MedDRA standard medical queries that were pre-defined as five BC AEFIs. Terminology mapping between MedDRA and WHO-ART terms was performed by three researchers. Descriptive statistics of individual case safety reports were analyzed according to BC applicability.Disproportionality analyses were performed on each BC AEFI and each preferred AEFI term according to the case-noncase approach; reporting odds ratio (ROR) and 95% confidence intervals (CI) were calculated. Results: Among the 30,266 reports of vaccinations between 2008 and 2017, 2,845 reports included the HPV vaccine. Of these reports, 1,511 (53.1%) included at least one BC AEFI. Reports from physicians or manufacturers included more BC AEFIs than from other reporters. Injection site reactions and fever were frequently reported in BC AEFIs; spontaneous abortion and ectopic pregnancy (ROR, 14.29 [95% CI, 4.30-47.49]) and vasculitic peripheral neuropathy (ROR, 8.57 [95% CI, 2.61-28.10]) showed the highest ROR. Among non-BC AEFIs, dizziness or myalgia were frequently reported; exposure during pregnancy (ROR, 23.95 [95% CI, 16.27-35.25]) and inappropriate schedule of administration (ROR, 22.89 [95% CI, 16.74-31.31]) showed the highest ROR. Conclusion BC criteria would be applicable for labeled AEFIs, whereas analyzing non-BC AEFIs would be useful for detecting unlabeled AEFIs.

Objective: To describe patterns of spontaneous reporting on adverse events following immunization (AEFIs) using the human papilloma virus (HPV) vaccine according to the Brighton Collaboration (BC) criteria. Methods: We used the Korea Adverse Event Reporting System (KAERS) database including vaccinations between 2008 and 2017. To apply BC criteria, we classified 58 BC AEFIs into World Health Organization Adverse Reaction Terminology (WHO-ART) codes. We applied MedDRA standard medical queries that were pre-defined as five BC AEFIs. Terminology mapping between MedDRA and WHO-ART terms was performed by three researchers. Descriptive statistics of individual case safety reports were analyzed according to BC applicability.Disproportionality analyses were performed on each BC AEFI and each preferred AEFI term according to the case-noncase approach; reporting odds ratio (ROR) and 95% confidence intervals (CI) were calculated. Results: Among the 30,266 reports of vaccinations between 2008 and 2017, 2,845 reports included the HPV vaccine. Of these reports, 1,511 (53.1%) included at least one BC AEFI. Reports from physicians or manufacturers included more BC AEFIs than from other reporters. Injection site reactions and fever were frequently reported in BC AEFIs; spontaneous abortion and ectopic pregnancy (ROR, 14.29 [95% CI, 4.30-47.49]) and vasculitic peripheral neuropathy (ROR, 8.57 [95% CI, 2.61-28.10]) showed the highest ROR. Among non-BC AEFIs, dizziness or myalgia were frequently reported; exposure during pregnancy (ROR, 23.95 [95% CI, 16.27-35.25]) and inappropriate schedule of administration (ROR, 22.89 [95% CI, 16.74-31.31]) showed the highest ROR. Conclusion BC criteria would be applicable for labeled AEFIs, whereas analyzing non-BC AEFIs would be useful for detecting unlabeled AEFIs.

Purpose: Non-vitamin K antagonist oral anticoagulants (NOACs) are widely used in patients with atrial fibrillation (AF) because of their effectiveness in preventing stroke and their better safety, compared with warfarin. However, there are concerns for an increased risk of bleeding associated with concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs) or selective serotonin reuptake inhibitors (SSRIs) with NOACs. In this study, we aimed to evaluate the risk of bleeding events in individuals taking concomitant NSAIDs or SSRIs with NOACs after being diagnosed with AF. Materials and Methods: A nested case-control analysis to assess the safety of NSAIDs and SSRIs among NOAC users with AF was performed using data from Korean National Health Insurance Service from January 2012 to December 2017.Among patients who were newly prescribed NOACs, 1233 cases hospitalized for bleeding events were selected, and 24660 controls were determined. Results: The risk of bleeding events was higher in patients receiving concomitant NSAIDs [adjusted odds ratio (aOR) 1.41; 95% confidence interval (CI) 1.24–1.61] or SSRIs (aOR 1.92; 95% CI 1.52–2.42) with NOACs, compared to no use of either drug, respectively.The risk of upper gastrointestinal bleeding was higher in patients receiving concomitant NSAIDs or SSRIs without proton pump inhibitors (PPIs) (NSAIDs: aOR 2.47; 95% CI 1.26–4.83, SSRI: aOR 10.8; 95% CI 2.41–2.48) compared to no use. Conclusion When NSAIDs or SSRIs are required for NOAC users with AF, physicians need to monitor bleeding events and consider the use of PPIs, especially for combined use of both drugs or when initiating NOACs treatment.

PURPOSE: We compared the treatment results and toxicity in nasopharyngeal carcinoma (NPC) patients treated with concurrent chemotherapy (CCRT) alone (the CRT arm) or neoadjuvant chemotherapy followed by CCRT (the NCT arm). MATERIALS AND METHODS: A multi-institutional retrospective study was conducted to review NPC patterns of care and treatment outcome. Data of 568 NPC patients treated by CCRT alone or by neoadjuvant chemotherapy followed by CCRT were collected from 15 institutions. Patients in both treatment arms were matched using the propensity score matching method, and the clinical outcomes were analyzed. RESULTS: After matching, 300 patients (150 patients in each group) were selected for analysis. Higher 5-year locoregional failure-free survival was observed in the CRT arm (85% vs. 72%, p=0.014). No significant differences in distant failure-free survival (DFFS), disease-free survival (DFS), and overall survival were observed between groups. In subgroup analysis, the NCT arm showed superior DFFS and DFS in stage IV patients younger than 60 years. No significant difference in compliance and toxicity was observed between groups, except the radiation therapy duration was slightly shorter in the CRT arm (50.0 days vs. 53.9 days, p=0.018). CONCLUSION: This study did not show the superiority of NCT followed by CCRT over CCRT alone. Because NCT could increase the risk of locoregional recurrences, it can only be considered in selected young patients with advanced stage IV disease. The role of NCT remains to be defined and should not be viewed as the standard of care.
Arm ; Chemoradiotherapy ; Compliance ; Disease-Free Survival ; Drug Therapy* ; Humans ; Induction Chemotherapy ; Methods ; Nasopharyngeal Neoplasms ; Propensity Score* ; Radiotherapy ; Recurrence ; Republic of Korea ; Retrospective Studies* ; Standard of Care ; Treatment Outcome

BACKGROUND: We planned to compare the effect of intravenous oxycodone and fentanyl on post-operative pain after laparoscopic hysterectomy. METHODS: We examined 60 patients were randomized to postoperative pain treatment with either oxycodone (n = 30, Group O) or fentanyl (n = 30, Group F). The patients received 10 mg oxycodone/100 microg fentanyl with ketorolac 30 mg before the end of anesthesia and then continued with patient-controlled analgesia for 48 h postoperatively. RESULTS: The accumulated oxycodone consumption was less than fentanyl during 8, 24 and 48 h postoperatively. Numeric rating score of Group O showed significantly lower than that of Group F during 30 min, 2, 4, 8 and 24 h postoperatively. The incidences of adverse reactions were similar in the two groups, though the incidence of nausea was higher in the Group O during the 24 and 48 h postoperative period. CONCLUSIONS: Oxycodone IV-PCA was more advantageous than fentanyl IV-PCA for laparoscopic hysterectomy in view of accumulated oxycodone consumption, pain control and cost beneficial effect. However, patient satisfaction was not good in the group O compared to group F.
Analgesia, Patient-Controlled* ; Anesthesia ; Fentanyl* ; Humans ; Hysterectomy* ; Incidence ; Ketorolac ; Nausea ; Oxycodone* ; Pain, Postoperative ; Patient Satisfaction ; Postoperative Period