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.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.
4.Navigation guided small craniectomy and direct cannulation of pure isolated sigmoid sinus for treatment of dural arteriovenous fistula
Jun Ho SHIM ; Gi Yong YUN ; Jae-Min ANN ; Jong-Hyun PARK ; Hyuk-Jin OH ; Jai-Joon SHIM ; Seok Mann YOON
Journal of Cerebrovascular and Endovascular Neurosurgery 2024;26(1):71-78
Dural arteriovenous fistula (DAVF) is a rare condition affecting approximately 1.5% of 1,000,000 individuals annually. It frequently occurs in the transsigmoid and cavernous sinuses. An isolated sigmoid sinus is extremely rare and is treated by performing transfemoral transvenous embolization along the opposite transverse sinus.A 69-year-old woman presented with asymptomatic Borden type III/Cognard type III DAVF involving an isolated sigmoid sinus. She underwent a staged operation in which a navigation system was used to expose the sigmoid sinus in the operating room before transferring the patient to the angio suite for transvenous embolization.Various modalities have been used to treat DAVF, including surgical disconnection, transarterial embolization, transvenous embolization, and stereotactic radiosurgery. However, treating DAVF cases where the affected sinus is isolated can be challenging because an easily accessible surgical route may not be available. In this case, direct sinus cannulation and transvenous embolization were the most effective treatments.
5.Preliminary Report of Fully Endoscopic Microvascular Decompression
Gi-Yong YUN ; Jae-Min AHN ; Jong-Hyun PARK ; Hyuk-Jin OH ; Jai-Joon SHIM ; Seok-Mann YOON
Journal of Korean Neurosurgical Society 2024;67(6):646-653
Objective:
: Microscopic microvascular decompression (MVD) has been considered to be a useful treatment modality for medically refractory hemifacial spasm (HFS) and trigeminal neuralgia. But, the advent of the endoscopic era has presented new possibilities to MVD surgery. While the microscope remains a valuable tool, the endoscope offers several advantages with comparable clinical outcomes. Thus, fully endoscopic MVD (E-MVD) could be a reasonable alternative to microscopic MVD. This paper explores the safety and efficacy of the fully E-MVD technique.
Methods:
: A single-center retrospective study was conducted in 25 patients diagnosed with HFS between September 2019 and July 2023. All surgeries were performed by a single neurosurgeon using the fully E-MVD technique without any assistance of a microscope. The study reviewed intraoperative brainstem auditory evoked potentials and disappearance of the lateral spread response. Outcomes were assessed based on the patients’ clinical status immediately after surgery and at their last follow-up. Complications, including facial palsy, hearing loss, ataxia, dysphagia, palsy of other cranial nerves, and cerebrospinal fluid leakage, were also examined.
Results:
: The most common offending artery was the anterior inferior cerebellar artery (AICA) in 15 cases (60.0%), followed by the posterior inferior cerebellar artery in eight cases (32.0%), vertebral artery (VA) in one case (4.0%), tandem lesions involving the AICA and VA in one case (4.0%). Ten patients (40.0%) had pre-operative facial palsy on the ipsilateral side, and eight patients (32.0%) experienced delayed facial palsy on the ipsilateral side, from which they fully recovered by the last follow-up. The median operation time was 105 minutes. All patients were symptom free immediately after surgery and at the last follow-up. One patient experienced a permanent complication, such as high-frequency hearing loss, from which he partially recovered over time.
Conclusion
: Fully E-MVD demonstrated similar clinical outcomes to microscopic MVD. It offered a similar complication rate, shorter operation time, and a panoramic view with a smaller craniectomy size. Although there is a learning curve associated with fully E-MVD, it presents a viable alternative in the endoscopic era.
6.Multiple Cerebral Hemorrhages Caused by Paradoxical Reperfusion Injury After Cranioplasty
Hyuk-Jin OH ; Jai-Joon SHIM ; Jae-Min AHN ; Jae-Sang OH ; Seok-Mann YOON
Korean Journal of Neurotrauma 2022;18(2):335-340
Cranioplasty-related reperfusion injury has rarely been reported. Although there are several hypotheses, particularly regarding the mechanisms of the event, clear evidence is lacking. Here, we report the case of an 84-year-old man with traumatic intracranial hemorrhage and subdural hematoma who underwent decompressive craniectomy and hematoma evacuation in the right hemisphere. After 45 days, cranioplasty was performed using titanium. A preoperative perfusion study with 99m-Tc-HMPAO brain single-photon emission tomography revealed diffuse hypoperfusion in the left cerebral hemisphere with decreased vascular reserve. After cranioplasty, multiple cerebral hemorrhages were observed on immediate postoperative computed tomography. Cerebral hemorrhage eventually improved without surgery. Here, we report a case with findings revealed through perfusion studies before and after surgery.
7.Comparison of clinicopathological characteristics and prognosis in breast cancer patients with different Breast Imaging Reporting and Data System categories
Bong Kyun KIM ; Jai Min RYU ; Se Jeong OH ; Jaihong HAN ; Jung Eun CHOI ; Joon JEONG ; Young Jin SUH ; Jina LEE ; Woo Young SUN ;
Annals of Surgical Treatment and Research 2021;101(3):131-139
Purpose:
The Breast Imaging Reporting and Data System (BI-RADS) is a systematic and standardized scheme of the radiological findings of breast. However, there were different BI-RADS categories between breast cancers as the clinical characteristics in previous studies. We analyzed the association of BI-RADS categories with the clinicopathological characteristics and prognosis of breast cancer.
Methods:
A total of 44,184 patients with invasive breast cancers assigned to BI-RADS category 3, 4, or 5 in preoperative mammography or ultrasonography were analyzed retrospectively using large-scale data from the Korean Breast Cancer Society registration system. The difference in the clinicopathological factors and prognoses according to the BI-RADS categories (BI-RADS 3–4 and BI-RADS 5) were compared between the mammography and ultrasonography groups. Comparisons of the clinicopathological factors in both groups were made using logistic regression analysis, while the prognoses were based on the breast cancer-specific survival using the Kaplan-Meier method and Cox proportional hazards model.
Results:
The factors associated with BI-RADS were T stage, N stage, palpability, histology grade, and lymphovascular invasion in the mammography group; and N stage, palpability, histology grade, and lymphovascular invasion in the ultrasonography group. In the survival analysis, there were significant differences in the breast cancer-specific survival of the BI-RADS category groups in both of the mammography (hazard ratio [HR], 3.366; P < 0.001) and ultrasonography (HR, 2.877; P < 0.001) groups.
Conclusion
In this study, the BI-RADS categories of preoperative mammography and ultrasonography of patients with invasive breast cancer were associated with prognosis and could be an important factor in making treatment decisions.
8.Short and Long-term Outcomes of Subarachnoid Hemorrhage Treatment according to Hospital Volume in Korea: a Nationwide Multicenter Registry
Ji Young LEE ; Nam-Hun HEO ; Man Ryul LEE ; Jae Min AHN ; Hyuk-Jin OH ; Jai Joon SHIM ; Seok Mann YOON ; Bo Yeon LEE ; Ji Hyeonv SHIN ; Jae Sang OH
Journal of Korean Medical Science 2021;36(22):e146-
Background:
Subarachnoid hemorrhage is a potentially devastating cerebrovascular attack with a high proportion of poor outcomes and mortality. Recent studies have reported decreased mortality with the improvement in devices and techniques for treating ruptured aneurysms and neurocritical care. This study investigated the relationship between hospital volume and shortand long-term mortality in patients treated with subarachnoid hemorrhage.
Methods:
We selected subarachnoid hemorrhage patients treated with clipping and coiling from March–May 2013 to June–August 2014 using data from Acute Stroke Registry, and the selected subarachnoid hemorrhage (SAH) patients were tracked in connection with data of Health Insurance Review and Assessment Service to evaluate the short-term and long-term mortality.
Results:
A total of 625 subarachnoid hemorrhage patients were admitted to high-volume hospitals (n = 355, 57%) and low-volume hospitals (n = 270, 43%) for six months. The mortality of SAH patients treated with clipping and coiling was 12.3%, 20.2%, 21.4%, and 24.3% at 14 days, three months, one year, and five years, respectively. The short-term and long-term mortality in high-volume hospitals was significantly lower than that in low-volume hospitals. On Cox regression analysis of death in patients with severe clinical status, lowvolume hospitals had significantly higher mortality than high-volume hospitals during shortterm follow-up. On Cox regression analysis in the mild clinical status group, there was no statistical difference between high-volume hospitals and low-volume hospitals.
Conclusion
In subarachnoid hemorrhage patients treated with clipping and coiling, lowvolume hospitals had higher short-term mortality than high-volume hospitals. These results from a nationwide database imply that acute SAH should be treated by a skilled neurosurgeon with adequate facilities in a high-volume hospital.
9.Comparison of clinicopathological characteristics and prognosis in breast cancer patients with different Breast Imaging Reporting and Data System categories
Bong Kyun KIM ; Jai Min RYU ; Se Jeong OH ; Jaihong HAN ; Jung Eun CHOI ; Joon JEONG ; Young Jin SUH ; Jina LEE ; Woo Young SUN ;
Annals of Surgical Treatment and Research 2021;101(3):131-139
Purpose:
The Breast Imaging Reporting and Data System (BI-RADS) is a systematic and standardized scheme of the radiological findings of breast. However, there were different BI-RADS categories between breast cancers as the clinical characteristics in previous studies. We analyzed the association of BI-RADS categories with the clinicopathological characteristics and prognosis of breast cancer.
Methods:
A total of 44,184 patients with invasive breast cancers assigned to BI-RADS category 3, 4, or 5 in preoperative mammography or ultrasonography were analyzed retrospectively using large-scale data from the Korean Breast Cancer Society registration system. The difference in the clinicopathological factors and prognoses according to the BI-RADS categories (BI-RADS 3–4 and BI-RADS 5) were compared between the mammography and ultrasonography groups. Comparisons of the clinicopathological factors in both groups were made using logistic regression analysis, while the prognoses were based on the breast cancer-specific survival using the Kaplan-Meier method and Cox proportional hazards model.
Results:
The factors associated with BI-RADS were T stage, N stage, palpability, histology grade, and lymphovascular invasion in the mammography group; and N stage, palpability, histology grade, and lymphovascular invasion in the ultrasonography group. In the survival analysis, there were significant differences in the breast cancer-specific survival of the BI-RADS category groups in both of the mammography (hazard ratio [HR], 3.366; P < 0.001) and ultrasonography (HR, 2.877; P < 0.001) groups.
Conclusion
In this study, the BI-RADS categories of preoperative mammography and ultrasonography of patients with invasive breast cancer were associated with prognosis and could be an important factor in making treatment decisions.
10.Short and Long-term Outcomes of Subarachnoid Hemorrhage Treatment according to Hospital Volume in Korea: a Nationwide Multicenter Registry
Ji Young LEE ; Nam-Hun HEO ; Man Ryul LEE ; Jae Min AHN ; Hyuk-Jin OH ; Jai Joon SHIM ; Seok Mann YOON ; Bo Yeon LEE ; Ji Hyeonv SHIN ; Jae Sang OH
Journal of Korean Medical Science 2021;36(22):e146-
Background:
Subarachnoid hemorrhage is a potentially devastating cerebrovascular attack with a high proportion of poor outcomes and mortality. Recent studies have reported decreased mortality with the improvement in devices and techniques for treating ruptured aneurysms and neurocritical care. This study investigated the relationship between hospital volume and shortand long-term mortality in patients treated with subarachnoid hemorrhage.
Methods:
We selected subarachnoid hemorrhage patients treated with clipping and coiling from March–May 2013 to June–August 2014 using data from Acute Stroke Registry, and the selected subarachnoid hemorrhage (SAH) patients were tracked in connection with data of Health Insurance Review and Assessment Service to evaluate the short-term and long-term mortality.
Results:
A total of 625 subarachnoid hemorrhage patients were admitted to high-volume hospitals (n = 355, 57%) and low-volume hospitals (n = 270, 43%) for six months. The mortality of SAH patients treated with clipping and coiling was 12.3%, 20.2%, 21.4%, and 24.3% at 14 days, three months, one year, and five years, respectively. The short-term and long-term mortality in high-volume hospitals was significantly lower than that in low-volume hospitals. On Cox regression analysis of death in patients with severe clinical status, lowvolume hospitals had significantly higher mortality than high-volume hospitals during shortterm follow-up. On Cox regression analysis in the mild clinical status group, there was no statistical difference between high-volume hospitals and low-volume hospitals.
Conclusion
In subarachnoid hemorrhage patients treated with clipping and coiling, lowvolume hospitals had higher short-term mortality than high-volume hospitals. These results from a nationwide database imply that acute SAH should be treated by a skilled neurosurgeon with adequate facilities in a high-volume hospital.

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