1.Randomized Multicenter Study to Evaluate the Efficacy and Safety of Fexuprazan According to the Timing of Dosing in Patients With Erosive Esophagitis
Sang Pyo LEE ; In-Kyung SUNG ; Oh Young LEE ; Myung-Gyu CHOI ; Kyu Chan HUH ; Jae-Young JANG ; Hoon Jai CHUN ; Joong-Goo KWON ; Gwang Ha KIM ; Nayoung KIM ; Poong-Lyul RHEE ; Sang Gyun KIM ; Hwoon-Yong JUNG ; Joon Seong LEE ; Yong Chan LEE ; Hye-Kyung JUNG ; Jae Gyu KIM ; Sung Kook KIM ; Chong-il SOHN
Journal of Neurogastroenterology and Motility 2025;31(1):86-94
Background/Aims:
Fexuprazan, a novel potassium-competitive acid blocker, was developed for treating acid-related disorders. Pharmacokinetic and pharmacodynamic properties of fexuprazan, unlike those of proton pump inhibitors, are independent of food effect. This study aims to evaluate differences in efficacy and safety of fexuprazan in patients with erosive esophagitis (EE) according to the timing of dosing.
Methods:
In this multicenter, open-label noninferiority study, patients who had typical reflux symptoms with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg daily 30 minutes before or after meal. Treatment was completed after 2 weeks or 4 weeks when healing was endoscopically confirmed. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 4. Safety endpoints included treatment-emergent adverse events (TEAEs).
Results:
In the prior-to-meal group (n = 89) and after-meal group (n = 86), 4-week EE healing rates were 98.77% and 100.00% (difference, 0.01%; 95% CI, –0.01% to 0.04%) and 2-week EE healing rates were 95.77% and 97.14% (difference, 0.01%; 95% CI, –0.05% to 0.07%), respectively. TEAEs were 9.78% and 8.70% in the prior-to-meal group and the after-meal group, respectively.
Conclusions
Non-inferiority analysis revealed that taking fexuprazan after meal was non-inferior to taking fexuprazan before meals in patients with EE. The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing.
2.Randomized Multicenter Study to Evaluate the Efficacy and Safety of Fexuprazan According to the Timing of Dosing in Patients With Erosive Esophagitis
Sang Pyo LEE ; In-Kyung SUNG ; Oh Young LEE ; Myung-Gyu CHOI ; Kyu Chan HUH ; Jae-Young JANG ; Hoon Jai CHUN ; Joong-Goo KWON ; Gwang Ha KIM ; Nayoung KIM ; Poong-Lyul RHEE ; Sang Gyun KIM ; Hwoon-Yong JUNG ; Joon Seong LEE ; Yong Chan LEE ; Hye-Kyung JUNG ; Jae Gyu KIM ; Sung Kook KIM ; Chong-il SOHN
Journal of Neurogastroenterology and Motility 2025;31(1):86-94
Background/Aims:
Fexuprazan, a novel potassium-competitive acid blocker, was developed for treating acid-related disorders. Pharmacokinetic and pharmacodynamic properties of fexuprazan, unlike those of proton pump inhibitors, are independent of food effect. This study aims to evaluate differences in efficacy and safety of fexuprazan in patients with erosive esophagitis (EE) according to the timing of dosing.
Methods:
In this multicenter, open-label noninferiority study, patients who had typical reflux symptoms with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg daily 30 minutes before or after meal. Treatment was completed after 2 weeks or 4 weeks when healing was endoscopically confirmed. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 4. Safety endpoints included treatment-emergent adverse events (TEAEs).
Results:
In the prior-to-meal group (n = 89) and after-meal group (n = 86), 4-week EE healing rates were 98.77% and 100.00% (difference, 0.01%; 95% CI, –0.01% to 0.04%) and 2-week EE healing rates were 95.77% and 97.14% (difference, 0.01%; 95% CI, –0.05% to 0.07%), respectively. TEAEs were 9.78% and 8.70% in the prior-to-meal group and the after-meal group, respectively.
Conclusions
Non-inferiority analysis revealed that taking fexuprazan after meal was non-inferior to taking fexuprazan before meals in patients with EE. The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing.
3.Chromosomal Rearrangements in 1,787 Cases of Acute Leukemia in Korea over 15 Years
DongGeun SON ; Ho Cheol JANG ; Young Eun LEE ; Yong Jun CHOI ; Joo Heon PARK ; Ha Jin LIM ; Hyun-Jung CHOI ; Hee Jo BAEK ; Hoon KOOK ; Mihee KIM ; Ga-Young SONG ; Seo-Yeon AHN ; Sung-Hoon JUNG ; Deok-Hwan YANG ; Je-Jung LEE ; Hyeonug-Joon KIM ; Jae-Sook AHN ; Myung-Geun SHIN
Annals of Laboratory Medicine 2025;45(4):391-398
Background:
Chromosomal alterations serve as diagnostic and prognostic markers in acute leukemia. Given the evolving landscape of chromosomal abnormalities in acute leukemia, we previously studied these over two periods. In this study, we investigated the frequency of these abnormalities and clinical trends in acute leukemia in Korea across three time periods.
Methods:
We retrospectively analyzed data from 1,787 patients with acute leukemia (319 children and 1,468 adults) diagnosed between 2006 and 2020. Conventional cytogenetics, FISH, and multiplex quantitative PCR were used for analysis. The patient groups were divided according to the following three study periods: 2006–2009 (I), 2010–2015 (II), and 2016–2020 (III).
Results:
Chromosomal aberrations were detected in 92% of patients. The PML::RARA translocation was the most frequent. Over the 15-yr period, chromosomal aberrations showed minimal changes, with specific fusion transcripts being common among patients.ALL was more prevalent in children than in adults and correlated significantly with the ETV6::RUNX1 and RUNX1::RUNX1T1 aberrations. The incidence of ALL increased during the three periods, with PML::RARA remaining common.
Conclusions
The frequency of chromosomal abnormalities in acute leukemia has changed subtly over time. Notably, the age of onset of adult AML has continuously increased. Our results may help in establishing diagnoses and clinical treatment strategies and developing various molecular diagnostic platforms.
4.Randomized Multicenter Study to Evaluate the Efficacy and Safety of Fexuprazan According to the Timing of Dosing in Patients With Erosive Esophagitis
Sang Pyo LEE ; In-Kyung SUNG ; Oh Young LEE ; Myung-Gyu CHOI ; Kyu Chan HUH ; Jae-Young JANG ; Hoon Jai CHUN ; Joong-Goo KWON ; Gwang Ha KIM ; Nayoung KIM ; Poong-Lyul RHEE ; Sang Gyun KIM ; Hwoon-Yong JUNG ; Joon Seong LEE ; Yong Chan LEE ; Hye-Kyung JUNG ; Jae Gyu KIM ; Sung Kook KIM ; Chong-il SOHN
Journal of Neurogastroenterology and Motility 2025;31(1):86-94
Background/Aims:
Fexuprazan, a novel potassium-competitive acid blocker, was developed for treating acid-related disorders. Pharmacokinetic and pharmacodynamic properties of fexuprazan, unlike those of proton pump inhibitors, are independent of food effect. This study aims to evaluate differences in efficacy and safety of fexuprazan in patients with erosive esophagitis (EE) according to the timing of dosing.
Methods:
In this multicenter, open-label noninferiority study, patients who had typical reflux symptoms with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg daily 30 minutes before or after meal. Treatment was completed after 2 weeks or 4 weeks when healing was endoscopically confirmed. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 4. Safety endpoints included treatment-emergent adverse events (TEAEs).
Results:
In the prior-to-meal group (n = 89) and after-meal group (n = 86), 4-week EE healing rates were 98.77% and 100.00% (difference, 0.01%; 95% CI, –0.01% to 0.04%) and 2-week EE healing rates were 95.77% and 97.14% (difference, 0.01%; 95% CI, –0.05% to 0.07%), respectively. TEAEs were 9.78% and 8.70% in the prior-to-meal group and the after-meal group, respectively.
Conclusions
Non-inferiority analysis revealed that taking fexuprazan after meal was non-inferior to taking fexuprazan before meals in patients with EE. The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing.
5.Triglyceride-glucose index is an independent predictor of coronary artery calcification progression in patients with chronic kidney disease
Ye Eun KO ; Hyung Woo KIM ; Jung Tak PARK ; Seung Hyeok HAN ; Shin-Wook KANG ; Suah SUNG ; Kyu-Beck LEE ; Joongyub LEE ; Kook-Hwan OH ; Tae-Hyun YOO ;
Kidney Research and Clinical Practice 2024;43(3):381-390
Coronary artery calcification (CAC) is highly prevalent in patients with chronic kidney disease (CKD) and is associated with major adverse cardiovascular events and metabolic disturbances. The triglyceride-glucose index (TyGI), a novel surrogate marker of metabolic syndrome and insulin resistance, is associated with CAC in the general population and in patients with diabetes. This study investigated the association between the TyGI and CAC progression in patients with CKD, which is unknown. Methods: A total of 1,154 patients with CKD (grades 1–5; age, 52.8 ± 11.9 years; male, 688 [59.6%]) were enrolled from the KNOWCKD (KoreaN Cohort Study for Outcomes in Patients With Chronic Kidney Disease). The TyGI was calculated as follows: ln (fasting triglycerides × fasting glucose/2). Patients were classified into tertiles (low, intermediate, high) based on the TyGI. The primary outcome was annualized percentage change in CAC score [(percent change in CAC score + 1)12/follow-up months – 1] of ≥15%, defined as CAC progression. Results: During the 4-year follow-up, the percentage of patients with CAC progression increased across TyGI groups (28.6%, 37.5%, and 46.2% in low, intermediate, and high groups, respectively; p < 0.001). A high TyGI was associated with an increased risk of CAC progression (odds ratio [OR], 2.11; 95% confidence interval [CI], 1.14–3.88; p = 0.02) compared to the low group. Moreover, a 1-point increase in the TyGI was related to increased risk of CAC progression (OR, 1.55; 95% CI, 1.06–1.76; p = 0.02) after adjustment. Conclusion: A high TyGI may be a useful predictor of CAC progression in CKD.
6.Self-screening questionnaire for perianal fistulizing disease in patients with Crohn’s disease
O Seong KWEON ; Ben KANG ; Yoo Jin LEE ; Eun Soo KIM ; Sung Kook KIM ; Hyun Seok LEE ; Yun Jin CHUNG ; Kyeong Ok KIM ; Byung Ik JANG ;
The Korean Journal of Internal Medicine 2024;39(3):430-438
Background/Aims:
A poor prognostic factor for Crohn’s disease (CD) includes perianal fistulizing disease, including perianal fistula and/or perianal abscess. Currently, a tool to assess perianal symptoms in patients with CD remains nonexistent. This study aimed to develop a perianal fistulizing disease self-screening questionnaire for patients with CD.
Methods:
This prospective pilot study was conducted at three tertiary referral centers between January 2019 and May 2020. We formulated questions on perianal symptoms, including tenesmus, anal discharge, bleeding, pain, and heat. A 4-point Likert scale was used to rate each question. Patients with CD completed a questionnaire and underwent pelvic magnetic resonance imaging (MRI).
Results:
Overall, 93 patients were enrolled, with 51 (54.8%) diagnosed with perianal fistulizing disease, as determined by pelvic MRI. The Spearman correlation findings demonstrated that anal pain (p = 0.450, p < 0.001) and anal discharge (p = 0.556, p < 0.001) were the symptoms that most significantly correlated with perianal disease. For anal pain and discharge, the area under the receiver operating characteristic curve of the scores was significantly higher than that of the combined score for all five symptoms (0.855 vs. 0.794, DeLong’s test p = 0.04). For the two symptoms combined, the sensitivity, specificity, and positive predictive and negative predictive values were 88.2, 73.8, 80.4, and 83.8%, respectively, with 81.7% accuracy for detecting perianal fistulizing disease.
Conclusions
This study indicates that simple questions regarding anal pain and discharge can help accurately identify the presence of perianal fistulizing disease in patients with CD.
7.Deep learning-based surgical phase recognition in laparoscopic cholecystectomy
Hye Yeon YANG ; Seung Soo HONG ; Jihun YOON ; Bokyung PARK ; Youngno YOON ; Dai Hoon HAN ; Gi Hong CHOI ; Min-Kook CHOI ; Sung Hyun KIM
Annals of Hepato-Biliary-Pancreatic Surgery 2024;28(4):466-473
Background:
s/Aims: Artificial intelligence (AI) technology has been used to assess surgery quality, educate, and evaluate surgical performance using video recordings in the minimally invasive surgery era. Much attention has been paid to automating surgical workflow analysis from surgical videos for an effective evaluation to achieve the assessment and evaluation. This study aimed to design a deep learning model to automatically identify surgical phases using laparoscopic cholecystectomy videos and automatically assess the accuracy of recognizing surgical phases.
Methods:
One hundred and twenty cholecystectomy videos from a public dataset (Cholec80) and 40 laparoscopic cholecystectomy videos recorded between July 2022 and December 2022 at a single institution were collected. These datasets were split into training and testing datasets for the AI model at a 2:1 ratio. Test scenarios were constructed according to structural characteristics of the trained model. No pre- or post-processing of input data or inference output was performed to accurately analyze the effect of the label on model training.
Results:
A total of 98,234 frames were extracted from 40 cases as test data. The overall accuracy of the model was 91.2%. The most accurate phase was Calot’s triangle dissection (F1 score: 0.9421), whereas the least accurate phase was clipping and cutting (F1 score:0.7761).
Conclusions
Our AI model identified phases of laparoscopic cholecystectomy with a high accuracy.
8.Capsular Contracture After Postmastectomy Radiation in Implant-Based Breast Reconstruction:Effect of Implant Pocket and Two-Stage Surgery
Sohyun MOON ; Kyunghyun MIN ; Tae Ho KIM ; Jung Hwan UM ; Yoonwon KOOK ; Seung Ho BAEK ; In Sik YUN ; Tai Suk ROH ; Soong June BAE ; Joon JEONG ; Sung Gwe AHN ; Young Seok KIM
Journal of Breast Cancer 2024;27(6):395-406
Capsular contracture (CC) is a concerning issue for individuals undergoing postmastectomy radiation therapy (PMRT) with implant-based breast reconstruction. This study investigated whether the extent of CC and implant migration differs based on implant placement and the reconstruction stage. Insertion plane and stage of breast implants were investigated, and the presence and severe cases of CC and implant migration were analyzed. Among 195 participants, 83 were in the pre-pectoral group, and 112 were in the sub-pectoral group. Two-staged surgery was performed on 116 patients, while 79 underwent direct-to-implant (DTI).Notably, The occurrence of CC (prepectoral, 17 [20.48%] and subpectoral, 42 [37.50%];p = 0.011), CC severity (prepectoral, 4 [4.82%] and subpectoral, 17 [15.17%]; p = 0.021), and implant upward migration (prepectoral, 15 [18.07%] and subpectoral, 38 [33.92%]; p = 0.014) significantly varied between the two groups. The incidence of CC was more common in the DTI group (odds ratio [OR], 2.283; 95% confidence interval [CI], 1.164–4.478). Furthermore, subpectoral placement was an independent risk factor for occurrence (OR, 2.989; 95% CI, 1.476–6.054) and severity of CC (OR, 38.552; 95% CI, 1.855–801.186) and upward implant migration (OR, 2.531; 95% CI, 1.263–5.071). Our findings suggest that pre-pectoral reconstruction and the two-stage operation benefit patients who may undergo PMRT. These approaches can help reduce the incidence of CC and abnormal implant migration following radiation, leading to improved aesthetic outcomes and greater patient satisfaction.
9.Deep learning-based surgical phase recognition in laparoscopic cholecystectomy
Hye Yeon YANG ; Seung Soo HONG ; Jihun YOON ; Bokyung PARK ; Youngno YOON ; Dai Hoon HAN ; Gi Hong CHOI ; Min-Kook CHOI ; Sung Hyun KIM
Annals of Hepato-Biliary-Pancreatic Surgery 2024;28(4):466-473
Background:
s/Aims: Artificial intelligence (AI) technology has been used to assess surgery quality, educate, and evaluate surgical performance using video recordings in the minimally invasive surgery era. Much attention has been paid to automating surgical workflow analysis from surgical videos for an effective evaluation to achieve the assessment and evaluation. This study aimed to design a deep learning model to automatically identify surgical phases using laparoscopic cholecystectomy videos and automatically assess the accuracy of recognizing surgical phases.
Methods:
One hundred and twenty cholecystectomy videos from a public dataset (Cholec80) and 40 laparoscopic cholecystectomy videos recorded between July 2022 and December 2022 at a single institution were collected. These datasets were split into training and testing datasets for the AI model at a 2:1 ratio. Test scenarios were constructed according to structural characteristics of the trained model. No pre- or post-processing of input data or inference output was performed to accurately analyze the effect of the label on model training.
Results:
A total of 98,234 frames were extracted from 40 cases as test data. The overall accuracy of the model was 91.2%. The most accurate phase was Calot’s triangle dissection (F1 score: 0.9421), whereas the least accurate phase was clipping and cutting (F1 score:0.7761).
Conclusions
Our AI model identified phases of laparoscopic cholecystectomy with a high accuracy.
10.Capsular Contracture After Postmastectomy Radiation in Implant-Based Breast Reconstruction:Effect of Implant Pocket and Two-Stage Surgery
Sohyun MOON ; Kyunghyun MIN ; Tae Ho KIM ; Jung Hwan UM ; Yoonwon KOOK ; Seung Ho BAEK ; In Sik YUN ; Tai Suk ROH ; Soong June BAE ; Joon JEONG ; Sung Gwe AHN ; Young Seok KIM
Journal of Breast Cancer 2024;27(6):395-406
Capsular contracture (CC) is a concerning issue for individuals undergoing postmastectomy radiation therapy (PMRT) with implant-based breast reconstruction. This study investigated whether the extent of CC and implant migration differs based on implant placement and the reconstruction stage. Insertion plane and stage of breast implants were investigated, and the presence and severe cases of CC and implant migration were analyzed. Among 195 participants, 83 were in the pre-pectoral group, and 112 were in the sub-pectoral group. Two-staged surgery was performed on 116 patients, while 79 underwent direct-to-implant (DTI).Notably, The occurrence of CC (prepectoral, 17 [20.48%] and subpectoral, 42 [37.50%];p = 0.011), CC severity (prepectoral, 4 [4.82%] and subpectoral, 17 [15.17%]; p = 0.021), and implant upward migration (prepectoral, 15 [18.07%] and subpectoral, 38 [33.92%]; p = 0.014) significantly varied between the two groups. The incidence of CC was more common in the DTI group (odds ratio [OR], 2.283; 95% confidence interval [CI], 1.164–4.478). Furthermore, subpectoral placement was an independent risk factor for occurrence (OR, 2.989; 95% CI, 1.476–6.054) and severity of CC (OR, 38.552; 95% CI, 1.855–801.186) and upward implant migration (OR, 2.531; 95% CI, 1.263–5.071). Our findings suggest that pre-pectoral reconstruction and the two-stage operation benefit patients who may undergo PMRT. These approaches can help reduce the incidence of CC and abnormal implant migration following radiation, leading to improved aesthetic outcomes and greater patient satisfaction.

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