Despite the availability of direct-acting antivirals (DAAs) for chronic hepatitis C virus (HCV) infection in Korea, need remains for pangenotypic regimens that can be used in the presence of hepatic impairment, comorbidities, or prior treatment failure. We investigated the efficacy and safety of sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir for 12 weeks in HCV-infected Korean adults. Methods: This Phase 3b, multicenter, open-label study included 2 cohorts. In Cohort 1, participants with HCV genotype 1 or 2 and who were treatment-naive or treatment-experienced with interferon-based treatments, received sofosbuvir–velpatasvir 400/100 mg/day. In Cohort 2, HCV genotype 1 infected individuals who previously received an NS5A inhibitor-containing regimen ≥ 4 weeks received sofosbuvir–velpatasvir–voxilaprevir 400/100/100 mg/day. Decompensated cirrhosis was an exclusion criterion. The primary endpoint was SVR12, defined as HCV RNA < 15 IU/mL 12 weeks following treatment. Results: Of 53 participants receiving sofosbuvir–velpatasvir, 52 (98.1%) achieved SVR12. The single participant who did not achieve SVR12 experienced an asymptomatic Grade 3 ASL/ALT elevation on day 15 and discontinued treatment. The event resolved without intervention. All 33 participants (100%) treated with sofosbuvir–velpatasvir–voxilaprevir achieved SVR 12. Overall, sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir were safe and well tolerated. Three participants (5.6%) in Cohort 1 and 1 participant (3.0%) in Cohort 2 had serious adverse events, but none were considered treatment-related. No deaths or grade 4 laboratory abnormalities were reported. Conclusions: Treatment with sofosbuvir–velpatasvir or sofosbuvir–velpatasvir–voxilaprevir was safe and resulted in high SVR12 rates in Korean HCV patients.

Background/Aims: Although endoscopic ultrasound (EUS)-guided fine needle aspiration (FNA) and fine needle biopsy (FNB) are widely used for tissue acquisition of pancreatic solid mass, the optimal strategy of this procedure has not been established yet. The aim of this nationwide study was to investigate the current practice patterns of EUS-FNA/FNB for pancreatic solid mass in Korea. Methods: The Policy-Quality Management of the Korean Pancreatobiliary Association (KPBA) developed a questionnaire containing 22 questions. An electronic survey consisting of the questionnaire was distributed by e-mail to members registered to the KPBA. Results: A total of 101 respondents completed the survey. Eighty respondents (79.2%) performed preoperative EUS-FNA/FNB for operable pancreatic solid mass. Acquire needles (60.4%) were used the most, followed by ProCore needles (47.5%). In terms of need size, most respondents (>80%) preferred 22-gauge needles regardless of the location of the mass. Negative suction with a 10-mL syringe (71.3%) as sampling technique was followed by stylet slow-pull (41.6%). More than three needle passes for EUS-FNA/FNB was performed by most respondents (>80%). The frequency of requiring repeated procedure was significantly higher in respondents with a low individual volume (<5 per month, p=0.001). Prophylactic antibiotics were routinely used in 39 respondents (38.6%); rapid on-site pathologic evaluation was used in 6.1%. Conclusions According to this survey, practices of EUS-FNA/FNB for pancreatic solid mass varied substantially, some of which differed considerably from the recommendations present in existing guidelines. These results suggest that the development of evidence-based quality guidelines fitting Korean clinical practice is needed to establish the optimal strategy for this procedure.

Background/Aims: This study aimed to investigate the patterns of preferred endoscopic procedure types and techniques for managing difficult common bile duct (CBD) stones in South Korea. Methods: The Committee of Policy and Quality Management of Korean Pancreatobiliary Association (KPBA) conducted a survey containing 19 questions. Both paper and online surveys were carried out; with the paper survey being conducted during the 2019 Annual Congress of KPBA and the online survey being conducted through Google Forms from April 2020 to February 2021. Results: The response rate was approximately 41.3% (86/208). Sixty-two (73.0%) worked at tertiary hospitals or academic medical centers, and 60 (69.7%) had more than 5 years of endoscopic retrograde cholangiopancreatography experience. The preferred size criteria for large CBD stones were 15 mm (40.6%), 20 mm (31.3%), and 30 mm (4.6%). For managing of large CBD stones, endoscopic papillary large balloon dilation after endoscopic sphincterotomy was the most preferred technique (74.4%). When performing procedures in those with bleeding diathesis, 64 (74.4%) respondents favored endoscopic papillary balloon dilation (EPBD) alone or EPBD with small endoscopic sphincterotomy. Fifty-five respondents (63.9%) preferred the doubleguidewire technique when faced with difficult bile duct cannulation in patients with periampullary diverticulum. In surgically altered anatomies, cap-fitted forward viewing endoscopy (76.7%) and percutaneous transhepatic cholangioscopy (48.8%) were the preferred techniques for Billroth-II anastomosis and total gastrectomy with Roux-en-Y anastomosis, respectively. Conclusions Most respondents showed unifying trends for the management of difficult CBD stones. The current practice patterns could be used as basic data for clinical quality improvements in the management of difficult CBD stones.

Background: The purpose of this study was to evaluate the effect of vanishing twin (VT) on maternal serum marker concentrations and nuchal translucency (NT). Methods: This is a secondary analysis of a multicenter prospective cohort study in 12 institutions. Serum concentrations of pregnancy-associated plasma protein-A in the first trimester and alpha-fetoprotein (AFP), total human chorionic gonadotrophin, unconjugated estriol, and inhibin A in the second trimester were measured, and NT was measured between 10 and 14 weeks of gestation. Results: Among 6,793 pregnant women, 5,381 women were measured for serum markers in the first or second trimester, including 65 cases in the VT group and 5,316 cases in the normal singleton group. The cases in the VT group had a higher median multiple of the median value of AFP and inhibin A than the normal singleton group. The values of other serum markers and NT were not different between the two groups. After the permutation test with adjustment,AFP and inhibin A remained significant differences. The frequency of abnormally increased AFP was also higher in the VT group than in the normal singleton group. Conclusion VT can be considered as an adjustment factor for risk assessment in the secondtrimester serum screening test.

Background/Aims: We examined the efficacy and safety of tegoprazan as a part of first-line triple therapy for Helicobacter pylori eradication. Methods: A randomized, double-blind, controlled, multicenter study was performed to evaluate whether tegoprazan (50 mg)-based triple therapy (TPZ) was noninferior to lansoprazole (30 mg)-based triple therapy (LPZ) (with amoxicillin 1 g and clarithromycin 500 mg; all administered twice daily for 7 days) for treating H. pylori. The primary endpoint was the H. pylori eradication rate. Subgroup analyses were performed according to the cytochrome P450 (CYP) 2C19 genotype, the minimum inhibitory concentration (MIC) of amoxicillin and clarithromycin, and underlying gastric diseases. Results: In total, 350 H. pylori-positive patients were randomly allocated to the TPZ or LPZ group. The H. pylori eradication rates in the TPZ and LPZ groups were 62.86% (110/175) and 60.57% (106/175) in an intention-to-treat analysis and 69.33% (104/150) and 67.33% (101/150) in a per-protocol analysis (non-inferiority test, p=0.009 and p=0.013), respectively. Subgroup analyses according to MICs or CYP2C19 did not show remarkable differences in eradication rate. Both first-line triple therapies were well-tolerated with no notable differences. Conclusions TPZ is as effective as proton pump inhibitor-based triple therapy and is as safe as first-line H. pylori eradication therapy but does not overcome the clarithromycin resistance of H. pylori in Korea

Background/Aims: Hip fracture and acute exacerbation of chronic obstructive pulmonary disease (AE-COPD) could increase mortality in patients with COPD. There are no data on the relationship between AE-COPD and hip fracture, which may significantly affect the prognosis of patients with COPD. Therefore, we conducted this study to determine the effects of AE-COPD on hip fractures in patients with COPD. Methods: This retrospective, nested, case-control study included 253,471 patients with COPD (≥ 40 years of age) identified from the Korea National Health Insurance Service-National Health Screening Cohort (NHIS-HEALS) from 2002 to 2015. Among 176,598 patients with COPD, 1,415 patients with hip fractures were identified. Each case was matched to one control for age (within 10 years), sex, and year of COPD diagnosis. We estimated the adjusted odds ratios (aORs) and 95% confidence intervals (CIs) for hip fractures associated with AE-COPD using conditional logistic regression analysis, adjusting for underlying diseases and smoking history. Results: In patients with AE-COPD, the risk of hip fracture was 2.50 times higher, regardless of systemic corticosteroid use and underlying disease (aOR, 2.50; 95% CI, 1.67 to 3.75). The risk of hip fracture increased if there was one episode of AE in the year before hip fractures (aOR, 2.25; 95% CI, 1.66 to 3.05). Moreover, the risk of hip fracture also increased in patients with more than two episodes of AE the year before hip fractures (aOR, 2.57; 95% CI, 1.61 to 4.10). Conclusions AE-COPD increases the risk of hip fracture regardless of underlying diseases, including osteoporosis, and treatment with systemic corticosteroids.

Background/Aims: The study aimed to investigate the current practice patterns in the management of pancreatic cystic neoplasms in Korea. Methods: An electronic survey was systematically distributed by email to members of the Korean Pancreatobiliary Association from December 2019 to February 2020. Results: In total, 115 (110 gastroenterologists, five surgeons) completed the survey, 72.2% of whom worked in a tertiary/academic medical center. Most (65.2%) followed the 2012/2017 International Association of Pancreatology guidelines for the management of pancreatic cystic neoplasms. A gadolinium-enhanced magnetic resonance imaging/magnetic resonance cholangiopancreatography was the most common first-line diagnostic modality (42.1%), but a contrast-enhanced computed tomography scan was preferred as a subsequent surveillance tool (58.3%). Seventy- four percent of respondents routinely performed endoscopic ultrasound-guided fine needle aspiration for pancreatic cystic neoplasms with suspicious mural nodules. Endoscopic ultrasound-guided fine needle aspiration cytology (94.8%) and cystic fluid carcinoembryonic antigen (95.7%) were used for cystic fluid analysis. Most (94%) typically recommended surgery in patients with high-risk stigmata, but 18.3% also considered proceeding with surgery in patients with worrisome features. Most (96.5%) would continue surveillance of pancreatic cystic neoplasms for more than 5 years. Conclusions According to this survey, there was variability in the management of pancreatic cystic neoplasms among the respondents. These results suggest that the development of evidence-based guidelines for pancreatic cystic neoplasms that fit the Korean practice is needed to create an optimal approach to the management of pancreatic cystic neoplasms.

Background: /Aim: Endoscopic retrograde choangiopancreatography (ERCP) has been established as an effective tool for the diagnosis and treatment of pancreatobiliary diseases. However, after the evolution for more than 4 decades, nationwide data on current trends and characteristic is not well known. Therefore, we conducted an analysis of nationwide database to determine the number and status of ERCP performed in Korea. Methods: We used the nationwide claims database, Korean Health Insurance Review and Assessment between 2012 and 2015. We investigated the frequencies and characteristics of ERCP procedure performed as well as demographics of the patients. Results: A total of 158,038 ERCP procedures were performed in 114,757 patients during study period. The number of total ERCPs increased every year, and especially the rate of therapeutic ERCPs is on the increased trend. About two-thirds of ERCPs (63.3%) were performed in high-scaled hospitals. In 2015, the proportion of elderly patients over 80 years old increased compared to that in 2011, from 14.3% to 17.2%. Conclusions The annual number of ERCPs performed is increasing in Korea. With increasing ERCP for therapeutic purposes or for older patients, more attention should be paid to safety for patients.

Background: /Aim: Endoscopic retrograde choangiopancreatography (ERCP) has been established as an effective tool for the diagnosis and treatment of pancreatobiliary diseases. However, after the evolution for more than 4 decades, nationwide data on current trends and characteristic is not well known. Therefore, we conducted an analysis of nationwide database to determine the number and status of ERCP performed in Korea. Methods: We used the nationwide claims database, Korean Health Insurance Review and Assessment between 2012 and 2015. We investigated the frequencies and characteristics of ERCP procedure performed as well as demographics of the patients. Results: A total of 158,038 ERCP procedures were performed in 114,757 patients during study period. The number of total ERCPs increased every year, and especially the rate of therapeutic ERCPs is on the increased trend. About two-thirds of ERCPs (63.3%) were performed in high-scaled hospitals. In 2015, the proportion of elderly patients over 80 years old increased compared to that in 2011, from 14.3% to 17.2%. Conclusions The annual number of ERCPs performed is increasing in Korea. With increasing ERCP for therapeutic purposes or for older patients, more attention should be paid to safety for patients.

Background/Aims: The work environment in which endoscopic retrograde cholangiopancreatography (ERCP) is conducted has influence on its efficacy and safety. We aimed to assess the current status of ERCP work environments and to investigate the trends associated with the basic techniques of ERCP in Korea. Methods: The work environment and information on the basic techniques of ERCP were acquired by the Korean Pancreatobiliary Association (KPBA) through a national survey in 2019. The survey was performed at the KPBA conference in 2019. The contents of survey comprised of the current environment of ERCP, preparation before ERCP, and the preferred basic techniques used in ERCP. Results: Completed questionnaires were returned from 84 KPBA members. The mean ERCP volume per year was approximately 500. About 60% (50/84) reported that they worked with a dedicated ERCP team with experienced nurses. Two-thirds (57/84, 68%) answered that they had a fluoroscopy room used solely for ERCP procedures. All respondents intravenously hydrated the patient to prevent post-ERCP pancreatitis (84/84, 100%). The preferred procedural sedations were balanced propofol sedation (50%) and midazolam-only sedation (47%). Wire-guided cannulation was most commonly used for selective cannulation (81%). Endoscopic retrograde biliary drainage was preferred over endoscopic nasobiliary drainage (60% vs 22%). The initial method of ampullary intervention was endoscopic sphincterotomy in 60%. Conclusions Data from the survey involving a large number of Korean ERCP doctors revealed considerable variabilities with regard to the work environment and basic techniques of ERCP in Korea. The study provides information regarding the current trends of ERCP that can be used to establish ERCP standards in Korea.