• 제목/요약/키워드: Multicenter

검색결과 366건 처리시간 0.027초

Safety and efficacy of early corticosteroid withdrawal in liver transplant recipients: A randomized controlled trial

  • Jongman Kim;Jae-Won Joh;Kwang-Woong Lee;Dong Lak Choi;Hee-Jung Wang
    • 한국간담췌외과학회지
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    • 제28권2호
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    • pp.238-247
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    • 2024
  • Backgrounds/Aims: Prolonged use of steroids after liver transplantation (LT) significantly increases the risk of diabetes or cardiovascular disease, which can adversely affect patient outcomes. Our study evaluated the effectiveness and safety of early steroid withdrawal within the first year following LT. Methods: This study was conducted as an open-label, multicenter, randomized controlled trial. Liver transplant recipients were randomly assigned to one of the following two groups: Group 1, in which steroids were withdrawn two weeks posttransplantation, and Group 2, in which steroids were withdrawn three months posttransplantation. This study included participants aged 20 to 70 years who were scheduled to undergo a single-organ liver transplant from a living or deceased donor at one of the four participating centers. Results: Between November 2012 and August 2020, 115 patients were selected and randomized into two groups, with 60 in Group 1 and 55 in Group 2. The incidence of new-onset diabetes after transplantation (NODAT) was notably higher in Group 1 (32.4%) than in Group 2 (10.0%) in the per-protocol set. Although biopsy-proven acute rejection, graft failure, and mortality did not occur, the median tacrolimus trough level/dose/weight in Group 1 exceeded that in Group 2. No significant differences in safety parameters, such as infection and recurrence of hepatocellular carcinoma, were observed between the two groups. Conclusions: The present study did not find a significant reduction in the incidence of NODAT in the early steroid withdrawal group. Our study suggests that steroid withdrawal three months posttransplantation is a standard and safe immunosuppressive strategy for LT patients.

Stereomicroscopic on-site evaluation in endoscopic ultrasound-guided tissue acquisition of upper gastrointestinal subepithelial lesions

  • Seigo Nakatani;Kosuke Okuwaki;Masafumi Watanabe;Hiroshi Imaizumi;Tomohisa Iwai;Takaaki Matsumoto;Rikiya Hasegawa;Hironori Masutani;Takahiro Kurosu;Akihiro Tamaki;Junro Ishizaki;Ayana Ishizaki;Mitsuhiro Kida;Chika Kusano
    • Clinical Endoscopy
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    • 제57권1호
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    • pp.89-95
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    • 2024
  • Background/Aims: In stereomicroscopic sample isolation processing, the cutoff value (≥4 mm) of stereomicroscopically visible white cores indicates high diagnostic sensitivity. We aimed to evaluate endoscopic ultrasound-guided tissue acquisition (EUS-TA) using a simplified stereomicroscopic on-site evaluation of upper gastrointestinal subepithelial lesions (SELs). Methods: In this multicenter prospective trial, we performed EUS-TA using a 22-gauge Franseen needle in 34 participants with SELs derived from the upper gastrointestinal muscularis propria, requiring pathological diagnosis. The presence of stereomicroscopically visible white core (SVWC) in each specimen was assessed using stereomicroscopic on-site evaluation. The primary outcome was EUS-TA's diagnostic sensitivity with stereomicroscopic on-site evaluation based on the SVWC cutoff value (≥4 mm) for malignant upper gastrointestinal SELs. Results: The total number of punctures was 68; 61 specimens (89.7%) contained stereomicroscopically visible white cores ≥4 mm in size. The final diagnoses were gastrointestinal stromal tumor, leiomyoma, and schwannoma in 76.5%, 14.7%, and 8.8% of the cases, respectively. The sensitivity of EUS-TA with stereomicroscopic on-site evaluation based on the SVWC cutoff value for malignant SELs was 100%. The per-lesion accuracy of histological diagnosis reached the highest level (100%) at the second puncture. Conclusions: Stereomicroscopic on-site evaluation showed high diagnostic sensitivity and could be a new method for diagnosing upper gastrointestinal SELs using EUS-TA.

Factors Predicting Difficult Biliary Cannulation during Endoscopic Retrograde Cholangiopancreatography for Common Bile Duct Stones

  • Hirokazu Saito;Yoshihiro Kadono;Takashi Shono;Kentaro Kamikawa;Atsushi Urata;Jiro Nasu;Haruo Imamura;Ikuo Matsushita;Tatsuyuki Kakuma;Shuji Tada
    • Clinical Endoscopy
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    • 제55권2호
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    • pp.263-269
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    • 2022
  • Background/Aims: Difficult biliary cannulation is an important risk factor for post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). Therefore, this study aimed to identify the factors that predict difficult cannulation for common bile duct stones (CBDS) to reduce the risk for PEP. Methods: This multicenter retrospective study included 1,406 consecutive patients with native papillae who underwent ERCP for CBDS. Factors predicting difficult cannulation for CBDS were identified using univariate and multivariate analyses. Results: Univariate analysis showed that six factors significantly predicted difficult cannulation: ERCP performed by non-expert endoscopists, low-volume center, absence of acute cholangitis, normal serum bilirubin, intradiverticular papilla, and type of major duodenal papilla. Multivariate analysis identified ERCP performed by non-expert endoscopists (odds ratio [OR], 2.5; p<0.001), low-volume center (OR, 1.6; p<0.001), intradiverticular papilla (OR, 1.3; p=0.007), normal serum bilirubin (OR, 1.3; p=0.038), and absence of acute cholangitis (OR, 1.3; p=0.049) as factors significantly predicting difficult cannulation for CBDS. Conclusions: Initial cannulation by an experienced endoscopist, early rescue cannulation, or early takeover by an experienced endoscopist should be considered when performing ERCP for CBDS in the presence of factors predicting difficult cannulation.

Clinical application of a new hemostatic material using mussel-inspired catecholamine hemostat: A pilot study

  • Young-Mok Park;Hyung-Il Seo;Jae-Hoon Kim;Sung Pil Yoon;Haeshin Lee;Moon Sue Lee
    • 한국간담췌외과학회지
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    • 제26권1호
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    • pp.98-103
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    • 2022
  • Backgrounds/Aims: This study aimed to evaluate clinical application of InnoSEAL Plus (a mussel-inspired catecholamine hemostat) as a new hemostatic material for humans. Methods: Patients treated with topical hemostatic patches after liver resection were enrolled. They were divided into an experimental group (InnoSEAL Plus group) and two control groups (TachoSil® group and Surgicel Fibrillar® group) for efficacy evaluation. Results: A total of 15 patients were enrolled. Each group had five patients. The 3-minute hemostasis success rate was 80.0% (4/5 patients) in the InnoSEAL Plus group, 80.0% (4/5 patients) in the TachoSil® group, and 40.0% (2/5 patients) in the Surgicel Fibrillar® group, showing no significant difference in the success rate among these groups (p > 0.05). All three groups exhibited 100% success rate for 10-minute hemostasis. Both InnoSEAL Plus and TachoSil® groups had one patient developing adverse events, which were treated easily with drug administrations. Conclusions: InnoSEAL Plus is expected to be functionally not inferior to other conventional hemostatic agents. However, it is necessary to confirm this through multicenter prospective studies in the future.

A Web-based Platform for Managing Rehabilitation Outcome Measures

  • Sujin Kim;Jiwon Jeon;Haesu Lee
    • 한국전문물리치료학회지
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    • 제31권2호
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    • pp.174-181
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    • 2024
  • Background: Effective management of clinical assessment tools is critical in stroke and brain injury rehabilitation research. Managing rehabilitation outcome measures (ROMs) scores and training therapists in multicenter randomized clinical trials (RCTs) is challenging. Objects: The aim of this study was to develop a web-based platform, the Korean Rehabilitation Outcome Measurement (KoROM), to address these limitations and improve both therapist training and patient involvement in the rehabilitation process. Methods: The development of the KoROM spanned from June 2021 to July 2022, and included literature and web-based searches to identify relevant ROMs and design a user-friendly platform. Feedback from six physical therapy and informatics experts during pilot testing refined the platform. Results: Several clinical assessment tools categorized under the International Classification of Functioning, Disability, and Health (ICF) model are categorized in the KoROM. The therapist version includes patient management, assessment tool information, and data downloads, while the patient version provides a simplified interface for viewing scores and printing summaries. The master version provides full access to user information and clinical assessment scores. Therapists enter clinical assessment scores into the KoROM and learn ROMs through instructional videos and self-checklists as part of the therapist standardization process. Conclusion: The KoROM is a specialized online platform that improves the management of ROMs, facilitates therapist education, and promotes patient involvement in the rehabilitation process. The KoROM can be used not only in multi-site RCTs, but also in community rehabilitation exercise centers.

A Multicenter Study of Pertussis Infection in Adults with Coughing in Korea: PCR-Based Study

  • Park, Sunghoon;Lee, Myung-Gu;Lee, Kwan Ho;Park, Yong Bum;Yoo, Kwang Ha;Park, Jeong-Woong;Kim, Changhwan;Lee, Yong Chul;Park, Jae Seuk;Kwon, Yong Soo;Seo, Ki-Hyun;Kim, Hui Jung;Kwak, Seung Min;Kim, Ju-Ock;Lim, Seong Yong;Sung, Hwa-Young;Jung, Sang-Oun;Jung, Ki-Suck
    • Tuberculosis and Respiratory Diseases
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    • 제73권5호
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    • pp.266-272
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    • 2012
  • Background: Limited data on the incidence and clinical characteristics of adult pertussis infections are available in Korea. Methods: Thirty-one hospitals and the Korean Centers for Disease Control and Prevention collaborated to investigate the incidence and clinical characteristics of pertussis infections among adults with a bothersome cough in non-outbreak, ordinary outpatient settings. Nasopharyngeal aspirates or nasopharyngeal swabs were collected for polymerase chain reaction (PCR) and culture tests. Results: The study enrolled 934 patients between September 2009 and April 2011. Five patients were diagnosed as confirmed cases, satisfying both clinical and laboratory criteria (five positive PCR and one concurrent positive culture). Among 607 patients with cough duration of at least 2 weeks, 504 satisfied the clinical criteria of the US Centers for Disease Control and Prevention (i.e., probable case). The clinical pertussis cases (i.e., both probable and confirmed cases) had a wide age distribution ($45.7{\pm}15.5$ years) and cough duration (median, 30 days; interquartile range, 18.0~50.0 days). In addition, sputum, rhinorrhea, and myalgia were less common and dyspnea was more common in the clinical cases, compared to the others (p=0.037, p=0.006, p=0.005, and p=0.030, respectively). Conclusion: The positive rate of pertussis infection may be low in non-outbreak, ordinary clinical settings if a PCR-based method is used. However, further prospective, well-designed, multicenter studies are needed.

Long-term Efficacy of S-1 Monotherapy or Capecitabine Plus Oxaliplatin as Adjuvant Chemotherapy for Patients with Stage II or III Gastric Cancer after Curative Gastrectomy: a Propensity Score-Matched Multicenter Cohort Study

  • Lee, Chang Min;Yoo, Moon-Won;Son, Young-Gil;Oh, Sung Jin;Kim, Jong-Han;Kim, Hyoung-Il;Park, Joong-Min;Hur, Hoon;Jee, Ye Seob;Hwang, Sun-Hwi;Jin, Sung-Ho;Lee, Sang Eok;Park, Ji-Ho;Seo, Kyung Won;Park, Sungsoo;Kim, Chang Hyun;Jeong, In Ho;Lee, Han Hong;Choi, Sung Il;Lee, Sang-Il;Kim, Chan Young;Kim, In-Hwan;Son, Myoung-Won;Pak, Kyung Ho;Kim, Sungsoo;Lee, Moon-Soo;Min, Jae-Seok
    • Journal of Gastric Cancer
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    • 제20권2호
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    • pp.152-164
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    • 2020
  • Purpose: To compare long-term disease-free survival (DFS) between patients receiving tegafur/gimeracil/oteracil (S-1) or capecitabine plus oxaliplatin (CAPOX) adjuvant chemotherapy (AC) for gastric cancer (GC). Materials and Methods: This retrospective multicenter observational study enrolled 983 patients who underwent curative gastrectomy with consecutive AC with S-1 or CAPOX for stage II or III GC at 27 hospitals in Korea between February 2012 and December 2013. We conducted propensity score matching to reduce selection bias. Long-term oncologic outcomes, including DFS rate over 5 years (over-5yr DFS), were analyzed postoperatively. Results: The median and longest follow-up period were 59.0 and 87.6 months, respectively. DFS rate did not differ between patients who received S-1 and CAPOX for pathologic stage II (P=0.677) and stage III (P=0.899) GC. Moreover, hazard ratio (HR) for recurrence did not differ significantly between S-1 and CAPOX (reference) in stage II (HR, 1.846; 95% confidence interval [CI], 0.693-4.919; P=0.220) and stage III (HR, 0.942; 95% CI, 0.664-1.337; P=0.738) GC. After adjustment for significance in multivariate analysis, pT (4 vs. 1) (HR, 11.667; 95% CI, 1.595-85.351; P=0.016), pN stage (0 vs. 3) (HR, 2.788; 95% CI, 1.502-5.174; P=0.001), and completion of planned chemotherapy (HR, 2.213; 95% CI, 1.618-3.028; P<0.001) were determined as independent prognostic factors for DFS. Conclusions: S-1 and CAPOX AC regimens did not show significant difference in over-5yr DFS after curative gastrectomy in patients with stage II or III GC. The pT, pN stage, and completion of planned chemotherapy were prognostic factors for GC recurrence.

외국인과 내국인 산모 출생아의 비교 연구 (Comparative study of newborns of Asian immigrant and Korean women)

  • 박희옥;임재우;진현승;심재원;김민희;김천수;김은령;김승연;박상기;이정주
    • Clinical and Experimental Pediatrics
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    • 제52권10호
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    • pp.1119-1126
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    • 2009
  • 목 적 : 현재 내국인 남자와 외국인 여자와의 국제 결혼이 크게 증가하고 있으며 이에 따라 이들 사이에 출생하는 신생아의 수도증가하고 있다. 저자들은 아시아계 개발 도상권의 외국인 산모에서 출생한 신생아가 내국인 산모에게서 출생한 신생아에 비하여 어떠한 차이가 있는지 알아보고자 본 연구를 시행하였다. 방 법 : 2005년 1월부터 2008년 6월까지 국내 9개 병원에서 출생한 신생아 중 아시아계 개발 도상권 외국인 산모에서 태어난 333명을 대상으로 하였고, 무작위로 선택한 같은 출생년도, 성별과 재태 주령을 가진 내국인 산모에서 태어난 333명을 대조군으로 하였다. 이들 신생아의 의무기록을 기초로 산모의 국적, 나이, 과거력을 파악하였고, 신생아의 선천성 감염 여부와 신생아의 체중, 키, 두위를 통한 성장 상태와 유병률, 아프가 점수등을 후향적으로 조사하여 양 군을 비교하였다. 결 과 : 전체 18,840명 중 외국인 산모 출생아는 407명(2.1%)이었고 전체 미숙아 수는 5,061명(26.8%)이며 외국인 산모에서 출생한 미숙아는 85명(20.8%), 출생과 동시에 입원한 환아 수는 전체 8,577 (45.5%)이었고 이중 외국인 산모 출생아는 127명(31.2%)이었다. 외국인 산모군에서 산모 국적은 필리핀 69명, 베트남 141명, 중국 51명, 몽고 50명이었으며 기타 우즈베키스탄, 태국 등이 22명이었다. 외국인 산모군의 신생아는 남아 177명, 여아 156명으로 평균 출생체중은 $2,869.1{\pm}685.3gm$이었고, 대조군은 남아 177명, 여아 156명이며 출생체중은 $2,995.1{\pm}689.8gm$으로 외국인 산모군이 유의하게 작았다(P<0.05). 분만 당시 산모의 연령은 외국인 산모군이 $26.7{\pm}5.7$세, 대조군이 $30.8{\pm}4.1$세로 유의한 차이가 있었고(P<0.05), 산모 과거력의 차이는 없었으나 선천 매독 빈도는 외국인 산모군에서 유의하게 높았다(P<0.05). 그 외에 출생 시 두위, 신장, 유병률 및 사망률, 1분 및 5분 아프가 점수는 두 군간에 유의한 차이는 없었다. 결 론 : 아시아계 개발 도상권 외국인 산모에게 태어난 신생아는 내국인 산모 출생아에 비하여 선천 매독 감염의 빈도가 유의하게 높았고, 분만시 산모의 연령이 유의하게 적었으며 신생아의 체중이 유의하게 작았다. 하지만 산모의 과거력, 출생 직후 상태 및 신장, 두위, 유병률은 두 군간의 유의한 차이가 없었고 부당 경량아 및 자궁내 발육지연의 빈도 역시 차이가 없었다.

골 이식술 후 Osstem Implant (US II Plus/GS II)의 다기관 임상연구 (A multicenter clinical study of installed US II Plus/GS II Osstem implants after bone graft)

  • 정광;오철중;하지원;국민석;박홍주;오희균;김수관;김영균;김우철
    • 대한치과의사협회지
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    • 제50권12호
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    • pp.743-754
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    • 2012
  • urpose : The purpose of this study was to evaluate the US II plus/GS II Osstem$^{(R)}$ implants through the study for the clinical success rate during the installation of the Osstem¢Á implants after bone graft. Materials and Methods : This study was researched in the 4 medical institutions: Chonnam National University, Chosun University, Bundang Seoul National University Hospital, and FM dental clinic from May, 2002 to September, 2009. Based on the total number of 60 patients whose treatment was the installation of the US II plus/GS II Osstem¢Á implants after bone graft, we evaluated success rate of implants. We analysis the distribution of patient's age and gender, edentulous area, bone type, fixture length and diameter, installation and loading time, donor site, bone graft material and method, antagonistic teeth, and survival and success rate. From these analyses we got the following results. Results : 1. In this study, the total number of patients who have been installed with US II plus implant was 27, and total of 52 implants were installed. The average age was 38.9, with 16 male, and 11 female patients. 2. The total number of patients who have been installed with GS II implant was 33, and total of 54 implants were installed. The average age was 49.7, with 24 male, and 9 female patients. 3. As for bone graft method, either autogenous bone or a mix of autogenous and heterogenous bone was used(88.4%) for US II plus. Chin, iliac, and Maxillary tuberosity were the donor sites for autogenous bone graft, and onlay method of bone graft was performed. 4. Allogenic bone or a mix of autogenous and heterogenous bone was used(77.8%) for GS II. Chin, ramus, and tibia were the donor sites for autogenous bone graft, and GBR method of bone graft was performed. 5. The duration from the installation of implants to setting of final prosthesis was average of 16 months and 10 months for US II plus and GS II respectively. Also, the final follow up period was average of 31 months and 28 months respectively. During this period, one GS II implant was removed from 1 patient due to failure of early osteointegration. 6. The survival rates were 100% and 98.1%, and success rates were 94.2% and 94.4% for US II plus and GS II implant respectively. Conclusion : On the evaluation of our clinical study, both US II plus and GS II Osstem¢Á implants showed the excellent clinical results after bone graft.

키토산 함유 치약의 임상적 효과;Multicenter study (Clinical Efficacy of Toothpaste Containing Chitosan;Multicenter study)

  • 김민경;최성호;신승윤;류인철;허익;박준봉;조규성
    • Journal of Periodontal and Implant Science
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    • 제33권2호
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    • pp.167-178
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    • 2003
  • Many researches are being done to study the effect of toothpaste containing natural extracts. The aim of this study was to evaluate the plaque control effect and therapeutic effect of toothpaste products containing chitosan extract. 120 healthy subjects with gingivitis or early periodontitis were divided into two groups. Subjects in the experimental group only used toothpaste containing chitosan and subjects in the control group used toothpaste without chitosan. At first, subjects received scaling and tooth brushing instruction. Gingival index, bleeding index, probing pocket depth, probing attachment level were scored at baseline, 2 months, and 3 months, and plaque index were scored at baseline, 1 month, 2 months, 3 months. Gingival index of experimental group and control group at baseline, 2 months, and 3 months use were 0.71${\pm}$0.66, 0.49${\pm}$0.55, 0.36${\pm}$0.49 and 0.62${\pm}$0.58, 0.51${\pm}$0.52, 0.48${\pm}$0.50 (mean${\pm}$SD), respectively (statistically significant different at p <0.05 ). Plaque index of experimental group and control group at baseline, 1 month, 2 months, and 3 months were 0.52${\pm}$0.50, 0.43${\pm}$0.50, 0.39${\pm}$0.49, 0.29${\pm}$0.46 and 0.49${\pm}$0.50, 0.50${\pm}$0.50, 0.51${\pm}$0.50, 0.45${\pm}$0.50, respectively (statistically significant different at p<0.05 ). Bleeding index of experimental group and control group were 0.40${\pm}$0.49, 0.33${\pm}$0.47, 0.24${\pm}$0.43 and 0.40${\pm}$0.49,0,38${\pm}$0.49,0.30${\pm}$0.46, respectively (statistically significant different at p<0.05). Probing depth of experimental group and control group were 2.41${\pm}$0.64, 2.31${\pm}$0.60, 2.28${\pm}$0.55 and 2.51${\pm}$0.67, 2.47${\pm}$0.63,2.42${\pm}$0.62, respectively (statistically significant different at p${\pm}$0.66, 2.32${\pm}$0.62 and 2.54${\pm}$0.70, 2.51${\pm}$0.69,2.46${\pm}$0.66, respectively (statistically significant different at p<0.05 ). From these finding, it can be concluded that toothpaste containing chitosan have better plaque control effect and therapeutic effect on gingivitis and early periodontitis compared to conventional toothpastes.