Effectiveness and Adverse Events of Nirmatrelvir/Ritonavir Versus Molnupiravir for COVID-19 in Outpatient Setting: Multicenter Prospective Observational Study

Background@#In this study, we aimed to compare the effectiveness and adverse reactions of nirmatrelvir/ritonavir and molnupiravir in high-risk outpatients with coronavirus disease 2019 (COVID-19). @*Methods@#This multicenter prospective observational study evaluated the rate of hospitalization, death, and adverse events within 28 days of oral antiviral agent prescription (molnupiravir, n = 240; nirmatrelvir/ritonavir, n = 240) to 480 nonhospitalized adult patients with COVID-19 from August 2, 2022 to March 31, 2023. @*Results@#Patients receiving molnupiravir had a higher prevalence of comorbidities (85.8% vs. 70.4%; P < 0.001) and a higher Charlson comorbidity index (2.8 ± 1.4 vs. 2.5 ± 1.5; P = 0.009) than those receiving nirmatrelvir/ritonavir. Three patients required hospitalization (nirmatrelvir/ritonavir group, n = 1 [0.4%]; molnupiravir group, n = 2 [0.8%]; P = 1.000). Nirmatrelvir/ritonavir was associated with a higher risk of adverse events than molnupiravir (odds ratio [OR], 1.96; 95% confidence interval [CI], 1.27–3.03), especially for patients aged 65 years and older (OR, 3.04; 95% CI, 1.71–5.39). The severity of adverse events in both groups was mild to moderate and improved after discontinuation of medication. In the molnupiravir group, age ≥ 65 years (OR, 0.43 95% CI, 0.22–0.86) and appropriate vaccination (OR, 0.37; 95% CI, 0.15–0.91) reduced the occurrence of adverse events. @*Conclusion@#The rates of hospitalization and death were low and not significantly different between high-risk patients who received either nirmatrelvir/ritonavir or molnupiravir. Although adverse events were more frequent with nirmatrelvir/ritonavir than with molnupiravir, none were severe. Nirmatrelvir/ritonavir can be safely used to treat COVID-19, while molnupiravir could be considered as an alternative treatment option for high-risk groups.

Guidelines for Safe Drug Use / 대한내과학회지

Background/Aims@#In Korea, medications are available by prescription from a physician, or can be purchased over-the-counter (OTC) without a prescription. Education regarding both prescribed and OTC drugs is important to minimize side effects and avoid drug abuse. The risk of side effects due to polypharmacy is increasing due to the growing number of elderly patients with comorbidities. @*Methods@#There are various clinical guidelines for physicians, but it is difficult for patients and their caregivers to find published guidelines regarding drug use. In this regard, experts from nine subspecialties of internal medicine, geriatric medicine, and guideline development methodology formed a working group to develop guidelines for safe drug use under the Clinical Practice Guidelines Committee of the Korean Association of Internal Medicine. @*Results@#The main contents of this guideline are 1) safe and effective drug administration, 2) the proper use of analgesics (acetaminophen and nonsteroidal anti-inflammatory drugs), 3) the proper use of tranquilizers and sleeping pills to prevent drug abuse, 4) points to be aware of when taking multiple medications. @*Conclusions@#The guidelines were developed for patients and their caregivers to understand the general principles and precautions for drug use, including commonly used painkillers, mood stabilizers, sleeping pills, and polypharmacy. These guidelines could also be used as educational materials for physicians, nurses, and healthcare workers to educate patients and their caregivers.

Guidelines for Safe Drug Use / 대한내과학회지

Background/Aims@#In Korea, medications are available by prescription from a physician, or can be purchased over-the-counter (OTC) without a prescription. Education regarding both prescribed and OTC drugs is important to minimize side effects and avoid drug abuse. The risk of side effects due to polypharmacy is increasing due to the growing number of elderly patients with comorbidities. @*Methods@#There are various clinical guidelines for physicians, but it is difficult for patients and their caregivers to find published guidelines regarding drug use. In this regard, experts from nine subspecialties of internal medicine, geriatric medicine, and guideline development methodology formed a working group to develop guidelines for safe drug use under the Clinical Practice Guidelines Committee of the Korean Association of Internal Medicine. @*Results@#The main contents of this guideline are 1) safe and effective drug administration, 2) the proper use of analgesics (acetaminophen and nonsteroidal anti-inflammatory drugs), 3) the proper use of tranquilizers and sleeping pills to prevent drug abuse, 4) points to be aware of when taking multiple medications. @*Conclusions@#The guidelines were developed for patients and their caregivers to understand the general principles and precautions for drug use, including commonly used painkillers, mood stabilizers, sleeping pills, and polypharmacy. These guidelines could also be used as educational materials for physicians, nurses, and healthcare workers to educate patients and their caregivers.

Guidelines for Surgery of Confirmed or Suspected COVID-19 Patients

Coronavirus disease 2019 (COVID-19) has spread widely across the world since January 2020.There are many challenges when caring for patients with COVID-19, one of which is infection prevention and control. In particular, in cases where surgery must absolutely be performed, special infection control may be required in order to perform surgery without spreading infection within the hospital. We aim to present potentially useful recommendations for nondeferrable surgery for COVID-19 patients based on in vivo and in vitro research and clinical experiences from many countries.

Korean Registry for Improving Sepsis Survival (KISS): Protocol for a Multicenter Cohort of Adult Patients with Sepsis or Septic Shock

Sepsis is one of the significant causes of morbidity and mortality. The burden caused by sepsis has continued to increase in recent years in the Korea, highlighting the urgent need for the implementation of strategies to improve sepsis treatment outcomes. We therefore designed a web-based sepsis registry system (“Korean Registry for Improving Sepsis Survival” [KISS]) protocol to be used in hospitals in the Korea for evaluation of the epidemiology and clinical characteristics of patients with sepsis, via an analysis of outcome predictors. The inclusion criteria of this registry are as follows: adult patients ≥18 years admitted to the participating hospitals who are diagnosed with sepsis or septic shock. Demographic and clinical information data of the patients will be collected from hospital medical records and will be recorded in a case report form, which will be entered into a web-based data management system. The analysis of the collected data will be performed as follows: (1) epidemiological and clinical characteristics of sepsis and septic shock, (2) application of sepsis bundles and antibiotic stewardship, and (3) audit and feedback. In conclusion, we aim to build the comprehensive web-based sepsis registry in the Korea through a nation-wide network of participating hospitals. Information collected and analyzed through the KISS can be used for further improvements in the clinical management of sepsis. Furthermore, the KISS will facilitate research leading to the formulation of public health policies regarding sepsis bundle and antibiotic stewardship strategies in the Korea.

Molecular Epidemiology of Ciprofloxacin-Resistant Escherichia coli Isolated from Community-Acquired Urinary Tract Infections in Korea

Background@#Escherichia coli is the predominant causative pathogen for community-acquired urinary tract infections (UTIs), and the increase in fluoroquinolone-resistant E. coli is of great concern in Korea. The objectives of this study were to investigate the genotypic characteristics and molecular epidemiology of ciprofloxacin-resistant (CIP-R) E. coli isolated from community-acquired UTIs in Korea. @*Materials and Methods@#E. coli samples isolated from the blood or urine were collected from patients with community-acquired acute pyelonephritis aged 15 years and more who were admitted to 12 Korean hospitals from 1st April 2010 to 29th February 2012. Phylogenetic typing, multilocus sequence typing, and molecular characterization of β-lactamase and plasmidmediated quinolone resistance determinants were performed for CIP-R E. coli isolates. @*Results@#A total of 569 E. coli isolates were collected, and 122 (21.4%) isolates were CIP-R isolates. The most prevalent sequence type (ST) was ST131 (28.7%, 35/122), followed by ST393 (14.7%, 18/122), ST1193 (13.1%, 16/122), ST38 (9.0%, 11/122), and ST405 (8.2%, 10/122). The antimicrobial resistance rates of ST131 to cefepime (22.9%, 8/35), ST38 to gentamicin (100%, 11/11), and ST405 to cefotaxime (66.7%, 6/9) were significantly higher than the resistance rates of all other STs combined. Notably, 40% (4/10) of ST405 clones produced extendedspectrum β-lactamases and were co-resistant to trimethoprim/sulfamethoxazole. aac(6′)-1b-cr (20%, 7/35) and CTX-M-14 (40%, 4/10) were more frequently observed in ST131 and ST405 compared with other clones, respectively. @*Conclusions@#Among the CIP-R uropathogenic E. coli isolates in this study, ST131, ST38, and ST405 were specifically associated with antimicrobial resistance.

KSNM/KSID/KOSHIC Guidance for Nuclear Medicine Department Against the Coronavirus Disease 2019 (COVID-19) Pandemic / 대한핵의학회잡지

The dramatic spread of Coronavirus Disease 2019 (COVID-19) has profound impacts on every continent and life. Due to humanto-human transmission of COVID-19, nuclear medicine staffs also cannot escape the risk of infection from workplaces. Everystaff in the nuclear medicine department must prepare for and respond to COVID-19 pandemic which tailored to the characteristicsof our profession. This article provided the guidance prepared by the Korean Society of Nuclear Medicine (KSNM) incooperation with the Korean Society of Infectious Disease (KSID) and Korean Society for Healthcare-Associated InfectionControl and Prevention (KOSHIC) in managing the COVID-19 pandemic for the nuclear medicine department.We hope that thisguidance will support every practice in nuclear medicine during this chaotic period.

Clinical Effectiveness and Safety of Peramivir for Influenza Infection: Safe and Effective Antiviral Treatment

No abstract available.

Neutrophil Gelatinase-associated Lipocalin as a Predictor of Acute Kidney Injury in Patients during Treatment with Colistimethate Sodium

BACKGROUND: The emergence of multidrug-resistant, Gram-negative bacteria has resulted in reconsideration of colistimethate sodium (CMS) as a last resort for treatment of such infections. However, acute kidney injury (AKI) may represent a major limiting adverse effect of use of CMS. Early AKI detection in CMS-treated patients can help prevent progression to acute failure and reduce the need of renal replacement therapy. We hypothesized that plasma neutrophil gelatinase-associated lipocalin (NGAL) may be an early biomarker of AKI in CMS-treated patients. MATERIALS AND METHODS: This prospective cohort study included patients aged ≥20 years who received intravenous CMS between March 2014 and November 2015. AKI was defined according to Kidney Disease: Improving Global Outcomes criteria. The primary endpoint was the difference between the average time to AKI onset based on serum creatinine and empirically derived plasma NGAL levels. RESULTS: Among 109 CMS-treated patients, 23 patients (mean age, 61.3 ± 16.1 years; men, 65.2%) were evaluated. Thirteen (56.5%) patients fulfilled the AKI criteria. The mean time to AKI onset based on serum creatinine after CMS initiation was 78.15 ± 30.49 hours. AKI was detected approximately 22 hours earlier using plasma NGAL than when using serum creatinine as an indicator of AKI (P = 0.035). The baseline plasma NGAL level was 264.0 ± 167.3 ng/mL and 192.7 ± 65.3 ng/mL in patients with and without AKI, respectively (P = 0.218). The area under the curve for plasma NGAL level at 56 hours was 0.796 (95% confidence interval, 0.609–0.983; P = 0.017), with a sensitivity and specificity of 69.2% and 90.0%, respectively (cutoff value, 285 ng/mL). CONCLUSION: NGAL level was found to be a strong predictor of AKI. This study provides additional evidence of the utility of NGAL for AKI in patients with treated CMS. Plasma NGAL represent sensitive and specific predictive early biomarkers for AKI in patient treated CMS.

Mycobacterium avium Complex Infection-Related Immune Reconstitution Inflammatory Syndrome Mimicking Lymphoma in an Human Immunodeficiency Virus-Infected Patient

In acquired immunodeficiency syndrome (AIDS) patients, immune reconstitution inflammatory syndrome (IRIS) due to Mycobacterium avium complex (MAC) infection is one of the most difficult IRIS types to manage. We report an unusual case of MAC-associated IRIS. At first the patient was diagnosed human immunodeficiency virus (HIV) infection after he was admitted with pneumocystis pneumonia. After starting antiretroviral therapy he presented unmasked IRIS with MAC infection. Next, he was hospitalized with continuous loose stools and new-onset fever. Investigation included computed tomography (CT), which showed homogeneous enhancement and enlargement of the lymph nodes (LN), elevation of ferritin (>1,650 ng/mL) and lactate dehydrogenase (306 IU/L) levels, and F- fluorodeoxyglucose positron emission tomography/computed tomography (FDG PET/CT) scan, which showed increased FDG uptake. These findings were highly indicative of lymphoma. We performed laparoscopic biopsy of the mesenteric LN, and the biopsy culture grew MAC. So we made a diagnosis of MAC-associated. Therefore, IRIS must be considered as a possible diagnosis when AIDS patients develop new symptoms or exhibit exacerbations of existing symptoms. Furthermore the biopsies should be conducted.

Neutrophil Gelatinase-associated Lipocalin as a Predictor of Acute Kidney Injury in Patients during Treatment with Colistimethate Sodium

BACKGROUND: The emergence of multidrug-resistant, Gram-negative bacteria has resulted in reconsideration of colistimethate sodium (CMS) as a last resort for treatment of such infections. However, acute kidney injury (AKI) may represent a major limiting adverse effect of use of CMS. Early AKI detection in CMS-treated patients can help prevent progression to acute failure and reduce the need of renal replacement therapy. We hypothesized that plasma neutrophil gelatinase-associated lipocalin (NGAL) may be an early biomarker of AKI in CMS-treated patients. MATERIALS AND METHODS: This prospective cohort study included patients aged ≥20 years who received intravenous CMS between March 2014 and November 2015. AKI was defined according to Kidney Disease: Improving Global Outcomes criteria. The primary endpoint was the difference between the average time to AKI onset based on serum creatinine and empirically derived plasma NGAL levels. RESULTS: Among 109 CMS-treated patients, 23 patients (mean age, 61.3 ± 16.1 years; men, 65.2%) were evaluated. Thirteen (56.5%) patients fulfilled the AKI criteria. The mean time to AKI onset based on serum creatinine after CMS initiation was 78.15 ± 30.49 hours. AKI was detected approximately 22 hours earlier using plasma NGAL than when using serum creatinine as an indicator of AKI (P = 0.035). The baseline plasma NGAL level was 264.0 ± 167.3 ng/mL and 192.7 ± 65.3 ng/mL in patients with and without AKI, respectively (P = 0.218). The area under the curve for plasma NGAL level at 56 hours was 0.796 (95% confidence interval, 0.609–0.983; P = 0.017), with a sensitivity and specificity of 69.2% and 90.0%, respectively (cutoff value, 285 ng/mL). CONCLUSION: NGAL level was found to be a strong predictor of AKI. This study provides additional evidence of the utility of NGAL for AKI in patients with treated CMS. Plasma NGAL represent sensitive and specific predictive early biomarkers for AKI in patient treated CMS.

Mycobacterium avium Complex Infection-Related Immune Reconstitution Inflammatory Syndrome Mimicking Lymphoma in an Human Immunodeficiency Virus-Infected Patient

In acquired immunodeficiency syndrome (AIDS) patients, immune reconstitution inflammatory syndrome (IRIS) due to Mycobacterium avium complex (MAC) infection is one of the most difficult IRIS types to manage. We report an unusual case of MAC-associated IRIS. At first the patient was diagnosed human immunodeficiency virus (HIV) infection after he was admitted with pneumocystis pneumonia. After starting antiretroviral therapy he presented unmasked IRIS with MAC infection. Next, he was hospitalized with continuous loose stools and new-onset fever. Investigation included computed tomography (CT), which showed homogeneous enhancement and enlargement of the lymph nodes (LN), elevation of ferritin (>1,650 ng/mL) and lactate dehydrogenase (306 IU/L) levels, and F- fluorodeoxyglucose positron emission tomography/computed tomography (FDG PET/CT) scan, which showed increased FDG uptake. These findings were highly indicative of lymphoma. We performed laparoscopic biopsy of the mesenteric LN, and the biopsy culture grew MAC. So we made a diagnosis of MAC-associated. Therefore, IRIS must be considered as a possible diagnosis when AIDS patients develop new symptoms or exhibit exacerbations of existing symptoms. Furthermore the biopsies should be conducted.

Treatment and prophylaxis of influenza

Influenza is an acute respiratory disease caused by the influenza virus. Each year, it causes a significant disease burden, especially in older adults. Furthermore, influenza pandemics occasionally occur because of antigenic change. Common signs and symptoms of influenza include fever, cough, sore throat, headache, myalgia, and runny nose. Severe cases may progress to pneumonia, which causes shortness of breath, tachycardia, hypotension, and the need for supportive respiratory interventions. Mild cases are self-limited and supportive care is sufficient. Antiviral treatment shortens the clinical course if it is administered within 48 hours from the onset of disease. Neuraminidase inhibitors, such as oseltamivir, zanamivir, and peramivir, are widely used. Although annual vaccination is the best means of prevention, its effectiveness can vary from year to year and among different age and risk groups.

Treatment and prophylaxis of influenza

Influenza is an acute respiratory disease caused by the influenza virus. Each year, it causes a significant disease burden, especially in older adults. Furthermore, influenza pandemics occasionally occur because of antigenic change. Common signs and symptoms of influenza include fever, cough, sore throat, headache, myalgia, and runny nose. Severe cases may progress to pneumonia, which causes shortness of breath, tachycardia, hypotension, and the need for supportive respiratory interventions. Mild cases are self-limited and supportive care is sufficient. Antiviral treatment shortens the clinical course if it is administered within 48 hours from the onset of disease. Neuraminidase inhibitors, such as oseltamivir, zanamivir, and peramivir, are widely used. Although annual vaccination is the best means of prevention, its effectiveness can vary from year to year and among different age and risk groups.

Usefulness of Blood Cultures and Radiologic Imaging Studies in the Management of Patients with Community-Acquired Acute Pyelonephritis

BACKGROUND: The objective of this study was to examine the usefulness of blood cultures and radiologic imaging studies for developing therapeutic strategies in community-acquired acute pyelonephritis (CA-APN) patients. MATERIALS AND METHODS: We prospectively collected the clinical data of CA-APN patients who visited 11 hospitals from March 2010 to February 2011. RESULTS: Positive urine and blood cultures were obtained in 69.3% (568/820) and 42.7% (277/648), respectively, of a total of 827 CA-APN patients. Blood culture identified the urinary pathogen in 60 of 645 (9.3%) patients for whom both urine and blood cultures were performed; the organisms isolated from urine were inconsistent with those from blood in 11 and only blood cultures were positive in 49 patients. Final clinical failure was more common in the bacteremic patients than the non-bacteremic ones (8.0% vs. 2.7%, P = 0.003), as was hospital mortality (3.6% vs. 0.3%, P = 0.003). Likewise, durations of hospitalization and fever were significantly longer. Bacteremia was independent risk factor for mortality (OR 9.290, 1.145-75.392, P = 0.037). With regard to radiologic studies, the detection rate of APN was 84.4% (445/527) by abdominal computed tomography and 40% (72/180) by abdominal ultrasonography. Eighty-one of 683 patients (11.9%) were found to have renal abscess, perinephric abscess, urolithiasis, hydronephorosis/hydroureter or emphysematous cystitis, which could potentially impact on clinical management. Patients with Pitt score ≥ 1, flank pain or azotemia were significantly more likely to have such structural abnormalities. CONCLUSION: Blood cultures are clinically useful for diagnosis of CA-APN, and bacteremia is predictive factor for hospital mortality. Early radiologic imaging studies should be considered for CA-APN patients with Pitt scores ≥1, flank pain or azotemia.

Risk factors and etiology of surgical site infection after radical neck dissection in patients with head and neck cancer

BACKGROUND/AIMS: Surgical site infection (SSI) is a major complication after radical neck dissection (RND) in patients with head and neck cancer (HNC). We investigated the incidence, risk factors, and etiology of SSI among patients who underwent RND. METHODS: A retrospective cohort study was performed on HNC patients, excluding those with thyroid cancer, who underwent first RND at a teaching hospital between January 2006 and June 2010. Medical records were collected and analyzed to evaluate the risk factors and microbiological etiologies. RESULTS: A total of 370 patients underwent first RND. The overall incidence of SSI was 19.7% (73/370). Multivariate analysis showed that male sex (odds ratio [OR], 4.281; p = 0.004), cardiovascular diseases (OR, 1.941; p = 0.020), large amount of blood loss during surgery (OR, 4.213; p = 0.001), and surgery lasting longer than 6 hours (OR, 4.213; p = 0.002) were significantly associated with SSI. The most common causative pathogen was Staphylococcus aureus (32.6%), and 93.2% of S. aureus isolates were methicillin-resistant. Klebsiella pneumoniae (13/92, 14.1%), Pseudomonas aeruginosa (11/92, 12.0%), and Enterococcus species (11/92, 12.0%) were also frequently detected. CONCLUSIONS: Based on our results, we predict that certain groups of patients are at high risk for SSIs after major HNC surgery. Preventive measures or close monitoring in these patients may be required to reduce the likelihood of postoperative SSIs. Furthermore, even though additional research is required, we would consider changing the prophylactic antibiotic regimens according to the causative organisms.

Synchronous second primary cancers in patients with squamous esophageal cancer: clinical features and survival outcome

BACKGROUND/AIMS: Unexpected diagnosis of synchronous second primary cancers (SPC) complicates physicians' decision-making because clinical details of squamous esophageal cancer (EC) patients with SPC have been limited. We evaluated clinical features and treatment outcomes of patients with synchronous SPC detected during the initial staging of squamous EC. METHODS: We identified a total of 317 consecutive patients diagnosed with squamous EC. Relevant clinical and cancer-specific information were reviewed retrospectively. RESULTS: EC patients with synchronous SPC were identified in 21 patients (6.6%). There were significant differences in median age (70 years vs. 63 years, p = 0.01), serum albumin level (3.3 g/dL vs. 3.9 g/dL, p < 0.01) and body mass index (20.4 kg/m2 vs. 22.8 kg/m2, p = 0.01) between EC patients with and without SPC. Head and neck, lung and gastric cancers accounted for 18.2%, 22.7%, and 18.2% of SPC, respectively. Positron emission tomography-computed tomography (PET-CT) detected four cases (18.2%) of SPC that were missed on CT. Management plans were altered in 13 of 21 patients (61.9%) with detected SPC. Curative esophagectomy was attempted in 28.6% of EC patients with SPC (vs. 59.1% of patients without SPC; p = 0.006). EC patients with SPC had significantly lower 5-year survival than patients without SPC (10.6% vs. 36.7%, p = 0.008). CONCLUSIONS: Synchronous SPC were found in 6.6% of squamous EC patients, and PET-CT contributed substantially to the detection of synchronous SPC. EC patients with SPC had poor survival due to challenges of providing stage-appropriate treatment.

A Case of Septic Shock caused by Achromobacter xylosoxidans in an Immunocompetent Female Patient after Extracorporeal Shock Wave Lithotripsy for a Ureteral Stone

Achromobacter xylosoxidans can cause various types of infections, but its infection in humans is rare. A. xylosoxidans has been reported as a rare etiological agent of infections including primary bacteremia, catheter-related bloodstream infection, endocarditis, otitis, and pneumonia, particularly in immunocompromised hosts. We encountered a case of septic shock caused by A. xylosoxidans in a 52-year-old, immunocompetent woman with no underlying disease, who received extracorporeal shock wave lithotripsy to remove a left upper ureteral stone. She was treated with antibiotics to which the organism was susceptible but died as a result of septic shock.

Healthcare-associated Endocarditis by PVL-negative ST 72 SCCmec Type IV MRSA / 대한내과학회지

The prevalence of community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) has been increasing worldwide. In Korea, the most common genotype of CA-MRSA is the Panton-Valentine leukocidin-negative, sequence type 72 Staphylococcal cassette chromosome (SCC) mec type IV clone. However, within Korean hospitals, this strain is still not commonly reported. In this study, we describe a case of infective endocarditis caused by Panton-Valentine leukocidin-negative MRSA (ST72-SCCmec type IV A clone). Infection occurred after open reduction and internal fixation due to a right humerus fracture with cerebral hemorrhage. Initially, the patient was treated with linezolid, but with the onset of severe thrombocytopenia, the patient was switched to vancomycin therapy.

The Efficacy of a Newly Designed, Easy-to-Manufacture Training Simulator for Endoscopic Biopsy of the Stomach

BACKGROUND/AIMS: We developed a new endoscopic biopsy training simulator and determined its efficacy for improving the endoscopic biopsy skills of beginners. METHODS: This biopsy simulator, which presents seven biopsy sites, was constructed using readily available materials. We enrolled 40 participants: 14 residents, 11 first-year clinical fellows, 10 second-year clinical fellows, and five staff members. We recorded the simulation completion time for all participants, and then simulator performance was assessed via a questionnaire using the 7-point Likert scale. RESULTS: The mean times for completing the five trials were 417.7±138.8, 145.2±31.5, 112.7±21.9, and 90.5±20.0 seconds for the residents, first-year clinical fellows, second-year clinical fellows, and staff members, respectively. Endoscopists with less experience reported that they found this simulator more useful for improving their biopsy technique (6.8±0.4 in the resident group and 5.7±1.0 in the first-year clinical fellow group). The realism score of the simulator for endoscopic handling was 6.4±0.5 in the staff group. CONCLUSIONS: This new, easy-to-manufacture endoscopic biopsy simulator is useful for biopsy training for beginner endoscopists and shows good efficacy and realism.