• Title/Summary/Keyword: Multicenter clinical studies

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Safety and Efficacy of Flow Diverter Therapy for Unruptured Intracranial Aneurysm Compared to Traditional Endovascular Strategy : A Multi-Center, Randomized, Open-Label Trial

  • Kim, Junhyung;Hwang, Gyojun;Kim, Bum-Tae;Park, Sukh Que;Oh, Jae Sang;Ban, Seung Pil;Kwon, O-Ki;Chung, Joonho;Committee of Multicenter Research, Korean Neuroendovascular Society,
    • Journal of Korean Neurosurgical Society
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    • v.65 no.6
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    • pp.772-778
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    • 2022
  • Objective : Endovascular treatment of large, wide-necked intracranial aneurysms by coil embolization is often complicated by low rates of complete occlusion and high rates of recurrence. A flow diverter device has been shown to be safe and effective for the treatment of not only large and giant unruptured aneurysms, but small and medium aneurysms. However, in Korea, its use has only recently been approved for aneurysms <10 mm. This study aims to compare the safety and efficacy of flow diversion and coil embolization for the treatment of unruptured aneurysms ≥7 mm. Methods : The participants will include patients aged between 19 and 75 years to be treated for unruptured cerebral aneurysms ≥7 mm for the first time or for recurrent aneurysms after initial endovascular coil embolization. Participants assigned to a flow diversion cohort will be treated using any of the following devices : Pipeline Flex Embolization Device with Shield Technology (Medtronic, Minneapolis, MN, USA), Surpass Evolve (Stryker Neurovascular, Fremont, CA, USA), and FRED or FRED Jr. (MicroVention, Tustin, CA, USA). Participants assigned to a coil embolization cohort will undergo traditional endovascular coiling. The primary endpoint will be complete occlusion confirmed by cerebral angiography at 12 months after treatment. Secondary safety outcomes will evaluate periprocedural and post-procedural complications for up to 12 months. Results : The trial will begin enrollment in 2022, and clinical data will be available after enrollment and follow-up. Conclusion : This article describes the aim and design of a multi-center, randomized, open-label trial to compare the safety and efficacy of flow diversion versus traditional endovascular treatment for unruptured cerebral aneurysms ≥7 mm.

Non-atrophic gastric mucosa is an independently associated factor for superficial non-ampullary duodenal epithelial tumors: a multicenter, matched, case-control study

  • Azusa Kawasaki;Kunihiro Tsuji;Noriya Uedo;Takashi Kanesaka;Hideaki Miyamoto;Ryosuke Gushima;Yosuke Minoda;Eikichi Ihara;Ryosuke Amano;Kenshi Yao;Yoshihide Naito;Hiroyuki Aoyagi;Takehiro Iwasaki;Kunihisa Uchita;Hisatomi Arima;Hisashi Doyama
    • Clinical Endoscopy
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    • v.56 no.1
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    • pp.75-82
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    • 2023
  • Background/Aims: The etiology of superficial non-ampullary duodenal epithelial tumors (SNADETs) remains unclear. Recent studies have reported conflicting associations between duodenal tumor development and Helicobacter pylori infection or endoscopic gastric mucosal atrophy. As such, the present study aimed to clarify the relationship between SNADETs and H. pylori infection and/or endoscopic gastric mucosal atrophy. Methods: This retrospective case-control study reviewed data from 177 consecutive patients with SNADETs who underwent endoscopic or surgical resection at seven institutions in Japan over a three-year period. The prevalence of endoscopic gastric mucosal atrophy and the status of H. pylori infection were compared in 531 sex- and age-matched controls selected from screening endoscopies at two of the seven participating institutions. Results: For H. pylori infection, 85 of 177 (48.0%) patients exhibited SNADETs and 112 of 531 (21.1%) control patients were non-infected (p<0.001). Non-atrophic mucosa (C0 to C1) was observed in 96 of 177 (54.2%) patients with SNADETs and 112 of 531 (21.1%) control patients (p<0.001). Conditional logistic regression analysis revealed that non-atrophic gastric mucosa was an independent risk factor for SNADETs (odds ratio, 5.10; 95% confidence interval, 2.44-8.40; p<0.001). Conclusions: Non-atrophic gastric mucosa, regardless of H. pylori infection status, was a factor independently associated with SNADETs.

Nationwide Multicenter Study of Eosinophilic Esophagitis in Korean Children

  • Lee, Kunsong;Choe, Byung-Ho;Kang, Ben;Kim, Seung;Kim, Jae Young;Shim, Jung Ok;Lee, Yoo Min;Lee, Eun Hye;Jang, Hyo-Jeong;Ryoo, Eell;Yang, Hye Ran
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.23 no.3
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    • pp.231-242
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    • 2020
  • Purpose: In East Asian countries, there are only a few epidemiologic studies of eosinophilic esophagitis (EoE) and no studies in children. We investigated the incidence and compared the clinical characteristics of EoE and eosinophilic gastroenteritis involving the esophagus (EGEIE) in Korean children. Methods: A total of 910 children, who had symptoms of esophageal dysfunction, from 10 hospitals in Korea were included. EoE was diagnosed according to diagnostic guidelines and EGEIE was diagnosed when there were >15 eosinophils in the esophagus per high power field (HPF) and >20 eosinophils per HPF deposited in the stomach and duodenum with abnormal endoscopic findings. Results: Of the 910 subjects, 14 (1.5%) were diagnosed with EoE and 12 (1.3%) were diagnosed with EGEIE. Vomiting was the most common symptom in 57.1% and 66.7% of patients with EoE and EGEIE, respectively. Only diarrhea was significantly different between EoE and EGEIE (p=0.033). In total, 61.5% of patients had allergic diseases. Exudates were the most common endoscopic findings in EoE and there were no esophageal strictures in both groups. The median age of patients with normal endoscopic findings was significantly younger at 3.2 years, compared to the median age of 11.1 years in those with abnormal endoscopic findings (p=0.004). Conclusion: The incidence of EoE in Korean children was lower than that of Western countries, while the incidence of EGEIE was similar to EoE. There were no clinical differences except for diarrhea and no differences in endoscopic findings between EoE and EGEIE.

Epidemiology and Clinical Severity of the Hospitalized Children with Viral Croup (바이러스성 크루프로 입원하는 소아 환자의 역학적 특성과 임상적 중증도 평가)

  • Jeon, In Soo;Cho, Won Je;Lee, Jeongmin;Kim, Hwang Min
    • Pediatric Infection and Vaccine
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    • v.25 no.1
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    • pp.8-16
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    • 2018
  • Purpose: In this study, the clinical and epidemiological characteristics of patients admitted for viral croup were analyzed to evaluate disease severity based on the organism that caused the infection. Methods: We retrospectively reviewed the medical records of 302 patients who were admitted to the Department of Pediatrics at the Wonju Severance Hospital between May 2013 and December 2016 for viral croup. Patients who showed positive results on multiplex polymerase chain reaction were subsequently diagnosed with respiratory virus infection. The Westley scoring system was used to evaluate the severity of viral croup. Results: Of the 302 patients, 149 were admitted due to severe viral croup, including 88 boys and 61 girls, with a boy-to-girl ratio of 1.44:1. About 110 cases of parainfluenza virus infection have been reported, which accounted for almost half of the total cases. The other identified viruses included influenza virus, human rhinovirus, and respiratory syncytial virus. Analysis of the association between severe viral croup and causative pathogen revealed that only parainfluenza type 2 virus showed a significantly high risk. Parainfluenza type 2 virus did not show an age-based difference in frequency but showed relatively a higher frequency of infections during the summer and fall. Conclusions: In this study, parainfluenza virus type 2 was the only virus associated with severe viral croup. To facilitate proper preventive management, treatment, and prognosis evaluation of viral croup, prospective and multicenter studies should assess the additional variables and the severity of the virus. Additionally, further studies should be conducted to assess age-dependent influences, as well as the regional and seasonal incidence of viral infection.

Prevalence of Inflammatory Bowel Disease Unclassified, as Estimated Using the Revised Porto Criteria, among Korean Pediatric Patients with Inflammatory Bowel Disease

  • Sung Hee Lee;Minsoo Shin;Seo Hee Kim;Seong Pyo Kim;Hyung-Jin Yoon;Yangsoon Park;Jaemoon Koh;Seak Hee Oh;Jae Sung Ko;Jin Soo Moon;Kyung Mo Kim
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.27 no.4
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    • pp.206-214
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    • 2024
  • Purpose: Few studies have reported the prevalence of inflammatory bowel disease unclassified (IBDU) among Korean pediatric IBD (PIBD) population. To address this gap, we used two tertiary centers and nationwide population-based healthcare administrative data to estimate the prevalence of Korean pediatric IBDU at the time of diagnosis. Methods: We identified 136 patients aged 2-17 years with newly diagnosed IBD (94 Crohn's disease [CD] and 42 ulcerative colitis [UC]) from two tertiary centers in Korea between 2005 and 2017. We reclassified these 136 patients using the revised Porto criteria. To estimate the population-based prevalence, we analyzed Korean administrative healthcare data between 2005 and 2016, which revealed 3,650 IBD patients, including 2,538 CD and 1,112 UC. By extrapolating the reclassified results to a population-based dataset, we estimated the prevalence of PIBD subtypes. Results: Among the 94 CD, the original diagnosis remained unchanged in 93 (98.9%), while the diagnosis of one (1.1%) patient was changed to IBDU. Among the 42 UC, the original diagnosis remained unchanged in 13 (31.0%), while the diagnoses in 11 (26.2%), 17 (40.5%), and one (2.4%) patient changed to atypical UC, IBDU, and CD, respectively. The estimated prevalences of CD, UC, atypical UC, and IBDU in the Korean population were 69.5%, 9.4%, 8.0%, and 13.1%, respectively. Conclusion: This study is the first in Korea to estimate the prevalence of pediatric IBDU. This prevalence (13.1%) aligns with findings from Western studies. Large-scale prospective multicenter studies on PIBDU are required to examine the clinical features and outcomes of this condition.

Effectiveness of alendronate as an adjunct to scaling and root planing in the treatment of periodontitis: a meta-analysis of randomized controlled clinical trials

  • Chen, Jin;Chen, Qian;Hu, Bo;Wang, Yunji;Song, Jinlin
    • Journal of Periodontal and Implant Science
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    • v.46 no.6
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    • pp.382-395
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    • 2016
  • Purpose: Alendronate has been proposed as a local and systemic drug treatment used as an adjunct to scaling and root planing (SRP) for the treatment of periodontitis. However, its effectiveness has yet to be conclusively established. The purpose of the present meta-analysis was to assess the effectiveness of SRP with alendronate on periodontitis compared to SRP alone. Methods: Five electronic databases were used by 2 independent reviewers to identify relevant articles from the earliest records up to September 2016. Randomized controlled trials (RCTs) comparing SRP with alendronate to SRP with placebo in the treatment of periodontitis were included. The outcome measures were changes in bone defect fill, probing depth (PD), and clinical attachment level (CAL) from baseline to 6 months. A fixed-effect or random-effect model was used to pool the extracted data, as appropriate. Mean differences (MDs) with 95% confidence intervals (CIs) were calculated. Heterogeneity was assessed using the Cochrane ${\chi}^2$ and $I^2$ tests. Results: After the selection process, 8 articles were included in the meta-analysis. Compared with SRP alone, the adjunctive mean benefits of locally delivered alendronate were 38.25% for bone defect fill increase (95% CI=33.05%-43.45%; P<0.001; $I^2=94.0%$), 2.29 mm for PD reduction (95% CI=2.07-2.52 mm; P<0.001; $I^2=0.0%$) and 1.92 mm for CAL gain (95% CI=1.55-2.30 mm; P<0.001; $I^2=66.0%$). In addition, systemically administered alendronate with SRP significantly reduced PD by 0.36 mm (95% CI=0.18-0.55 mm; P<0.001; $I^2=0.0%$) and increased CAL by 0.39 mm (95% CI=0.11-0.68 mm; P=0.006; $I^2=6.0%$). Conclusions: The collective evidence regarding the adjunctive use of alendronate locally and systemically with SRP indicates that the combined treatment can improve the efficacy of non-surgical periodontal therapy on increasing CAL and bone defect fill and reducing PD. However, precautions must be exercised in interpreting these results, and multicenter studies evaluating this specific application should be carried out.

Assessing Abdominal Aortic Aneurysm Progression by Using Perivascular Adipose Tissue Attenuation on Computed Tomography Angiography

  • Shuai Zhang;Hui Gu;Na Chang;Sha Li;Tianqi Xu;Menghan Liu;Ximing Wang
    • Korean Journal of Radiology
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    • v.24 no.10
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    • pp.974-982
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    • 2023
  • Objective: Recent studies have highlighted the active and potential role of perivascular adipose tissue (PVAT) in atherosclerosis and aneurysm progression, respectively. This study explored the link between PVAT attenuation and abdominal aortic aneurysm (AAA) progression using computed tomography angiography (CTA). Materials and Methods: This multicenter retrospective study analyzed patients with AAA who underwent CTA at baseline and follow-up between March 2015 and July 2022. The following parameters were obtained: maximum diameter and total volume of the AAA, presence or absence of intraluminal thrombus (ILT), maximum diameter and volume of the ILT, and PVAT attenuation of the aortic aneurysm at baseline CTA. PVAT attenuation was divided into high (> -73.4 Hounsfield units [HU]) and low (≤ -73.4 HU). Patients who had or did not have AAA progression during the follow-up, defined as an increase in the aneurysm volume > 10 mL from baseline, were identified. Kaplan-Meier and multivariable Cox regression analyses were used to investigate the association between PVAT attenuation and AAA progression. Results: Our study included 167 participants (148 males; median age: 70.0 years; interquartile range: 63.0-76.0 years), of which 145 (86.8%) were diagnosed with AAA accompanied by ILT. Over a median period of 11.3 months (range: 6.0-85.0 months), AAA progression was observed in 67 patients (40.1%). Multivariable Cox regression analysis indicated that high baseline PVAT attenuation (adjusted hazard ratio [aHR] = 2.23; 95% confidence interval [CI], 1.16-4.32; P = 0.017) was independently associated with AAA progression. This association was demonstrated within the patients of AAA with ILT subcohort, where a high baseline PVAT attenuation (aHR = 2.23; 95% CI, 1.08-4.60; P = 0.030) was consistently independently associated with AAA progression. Conclusion: Elevated PVAT attenuation is independently associated with AAA progression, including patients of AAA with ILT, suggesting the potential of PVAT attenuation as a predictive imaging marker for AAA expansion.

Short-Term Outcomes of Laparoscopic Proximal Gastrectomy With Double-Tract Reconstruction Versus Laparoscopic Total Gastrectomy for Upper Early Gastric Cancer: A KLASS 05 Randomized Clinical Trial

  • Hwang, Sun-Hwi;Park, Do Joong;Kim, Hyung-Ho;Hyung, Woo Jin;Hur, Hoon;Yang, Han-Kwang;Lee, Hyuk-Joon;Kim, Hyoung-Il;Kong, Seong-Ho;Kim, Young Woo;Lee, Han Hong;Kim, Beom Su;Park, Young-Kyu;Lee, Young-Joon;Ahn, Sang-Hoon;Lee, In-Seob;Suh, Yun-Suhk;Park, Ji-Ho;Ahn, Soyeon;Han, Sang-Uk
    • Journal of Gastric Cancer
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    • v.22 no.2
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    • pp.94-106
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    • 2022
  • Purpose: Laparoscopic proximal gastrectomy with double-tract reconstruction (LPG-DTR) is a function-preserving procedure performed for treating upper early gastric cancer (EGC). However, few studies have compared the outcomes of LPG-DTR with those of laparoscopic total gastrectomy (LTG). This study aimed at comparing the short-term outcomes of LPG-DTR between LTG and upper EGC. Materials and Methods: For upper-third EGC, a multicenter, prospective, randomized trial was performed to compare those who underwent LPG-DTR with those who underwent LTG. Short-term outcomes, including clinicopathologic results, morbidity, mortality, and postoperative courses, were evaluated using a full analysis set based on the intention-to-treat principle and the per-protocol set. Results: Of the patients, 138 who fulfilled the criteria were randomized to each group. One patient in the LPG-DTR group withdrew consent. Sixty-eight patients underwent LPG-DTR and 69 underwent LTG. The operative time (LPG-DTR=219.4 minutes; LTG=201.8 minutes; P=0.085), estimated blood loss (LPG-DTR=76.0 mL; LTG=66.1 mL; P=0.413), and the morbidity rate (LPG-DTR=23.5%; LTG=17.4%; P=0.373) between the groups were not significantly different. No mortality occurred in either of the study groups. Two weeks post operation, the Visick scores for postprandial symptoms, including reflux symptoms, were not significantly different between the groups (P=0.749). Laboratory findings on postoperative day 5 were not significantly different between the groups. Conclusions: The short-term outcomes of LPG-DTR for upper EGC were comparable to those of LTG.

Effect of Non-contact Korean Medical Treatment for Patients Recovering at Home with Positive Coronavirus Disease 2019 Diagnostic Test Results at a Local Public Health Center: A Retrospective Chart Review (지역 보건소에서 시행한 코로나 바이러스 감염증-19 진단 검사상 양성인 재택치료 환자의 비대면 한의진료 효과: 후향적 차트 리뷰)

  • Jeon, Chaeheun;Choi, Daejun;Kim, Gyeongmuk;Kim, Hyejin;Leem, Jungtae;Chi, Gyoo-yong
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.36 no.4
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    • pp.130-137
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    • 2022
  • Due to the coronavirus disease 2019 (COVID-19) pandemic, appropriate management of sequelae and treatment of infectious symptoms became increasingly important healthcare issues. Although the practice guidelines and treatment cases based on the East Asian traditional medicine have been reported, there are rare studies on the use of Korean medicine in Korea. Therefore, this study aimed to present the progress of non-contact Korean medical treatment for infected patients at a local public health center using retrospective chart review. A total of 18 patients were prescribed with 5 days of herbal decoction and medicine extract covered by the national health insurance. With the questionnaire form, the progression and improvement of symptoms before and after treatment were evaluated using the numerical rating scale (NRS), and the treatment satisfaction and opinions were obtained. The symptoms such as cough (5.56±2.23 to 2.89±2.14), sputum (6.11±1,75 to 3.28±2.47), sore throat (6.06±2.70 to 1.47±1.62), anorexia (5.56±2.63 to 1.94±2.21), nausea (3.75±1.71 to 1.17±1.11), diarrhea (3.40±2.63 to 1.50±1.51), chest tightness (4.93±2.46 to 2.29±2.30) and fatigue (6.44±1.79 to 2.67±1.88) all improved according to the NRS, and the satisfaction with herbal medicine treatment on a 5-point Likert scale was 4.24±0.90. No side effects and adverse reactions were reported. Thereupon non-contact Korean medical treatment can be concluded that it effectively reduces the COVID-19 infection mild symptoms in restrictive extent. Since the retrospective data does not include a control group, the more confirmative data is needed by multicenter and large-scale controlled clinical study afterwards.

Development and Validation of AI Image Segmentation Model for CT Image-Based Sarcopenia Diagnosis (CT 영상 기반 근감소증 진단을 위한 AI 영상분할 모델 개발 및 검증)

  • Lee Chung-Sub;Lim Dong-Wook;Noh Si-Hyeong;Kim Tae-Hoon;Ko Yousun;Kim Kyung Won;Jeong Chang-Won
    • KIPS Transactions on Computer and Communication Systems
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    • v.12 no.3
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    • pp.119-126
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    • 2023
  • Sarcopenia is not well known enough to be classified as a disease in 2021 in Korea, but it is recognized as a social problem in developed countries that have entered an aging society. The diagnosis of sarcopenia follows the international standard guidelines presented by the European Working Group for Sarcopenia in Older People (EWGSOP) and the d Asian Working Group for Sarcopenia (AWGS). Recently, it is recommended to evaluate muscle function by using physical performance evaluation, walking speed measurement, and standing test in addition to absolute muscle mass as a diagnostic method. As a representative method for measuring muscle mass, the body composition analysis method using DEXA has been formally implemented in clinical practice. In addition, various studies for measuring muscle mass using abdominal images of MRI or CT are being actively conducted. In this paper, we develop an AI image segmentation model based on abdominal images of CT with a relatively short imaging time for the diagnosis of sarcopenia and describe the multicenter validation. We developed an artificial intelligence model using U-Net that can automatically segment muscle, subcutaneous fat, and visceral fat by selecting the L3 region from the CT image. Also, to evaluate the performance of the model, internal verification was performed by calculating the intersection over union (IOU) of the partitioned area, and the results of external verification using data from other hospitals are shown. Based on the verification results, we tried to review and supplement the problems and solutions.