• Title/Summary/Keyword: Multicenter study

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Safety of Laparoscopic Sentinel Basin Dissection in Patients with Gastric Cancer: an Analysis from the SENORITA Prospective Multicenter Quality Control Trial

  • An, Ji Yeong;Min, Jae Seok;Lee, Young Joon;Jeong, Sang Ho;Hur, Hoon;Han, Sang Uk;Hyung, Woo Jin;Cho, Gyu Seok;Jeong, Gui Ae;Jeong, Oh;Park, Young Kyu;Jung, Mi Ran;Park, Ji Yeon;Kim, Young Woo;Yoon, Hong Man;Eom, Bang Wool;Ryu, Keun Won;Sentinel Node Oriented Tailored Approach (SENORITA) Study Group
    • Journal of Gastric Cancer
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    • v.18 no.1
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    • pp.30-36
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    • 2018
  • Purpose: We investigated complications after laparoscopic sentinel basin dissection (SBD) for patients with gastric cancer who were enrolled in a quality control study, prior to the phase III trial of sentinel lymph node navigation surgery (SNNS). Materials and Methods: We analyzed prospective data from a Korean multicenter prerequisite quality control trial of laparoscopic SBD for gastric cancer and assessed procedure-related and surgical complications. All complications were classified according to the Clavien-Dindo Classification (CDC) system and were compared with the results of the previously published SNNS trial. Results: Among the 108 eligible patients who were enrolled in the quality control trial, 8 (7.4%) experienced complications during the early postoperative period. One patient with gastric resection-related duodenal stump leakage recovered after percutaneous drainage (grade IIIa in CDC). The other postoperative complications were mild and patients recovered with supportive care. No complications were directly related to the laparoscopic SBD procedure or tracer usage, and there were no mortalities. The laparoscopic SBD complication rates and patterns that were observed in this study were comparable to those of a previously reported trial. Conclusions: The results of our prospective, multicenter quality control trial demonstrate that laparoscopic SBD is a safe procedure during SNNS for gastric cancer.

Efficacy Profile of Cisapride in Laryngopharyngeal Reflux(LPR)-Related Symptoms(Open Multicenter Case Study & Open Multicenter Case Study between Cisapride & Ranitidine) (인후두위산역류증(Laryngopharyngeal Reflux : LPR) 관련 증상에 대한 시사프리드(Cisapride)의 효과)

  • 최홍식;고중화;김광문;김광현;김민식;김영모;김찬우;김춘동;김형태
    • Journal of the Korean Society of Laryngology, Phoniatrics and Logopedics
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    • v.9 no.2
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    • pp.115-127
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    • 1998
  • Laryngopharyngeal reflux(LPR) is one firm of the gastroesophageal reflux diseases(GERD). It is known to cause various kinds of otolaryngologic symptoms such as hoarseness, foreign body sensation in throat, chronic throat clearing, chronic cough, etc. Disease entities diagnosed by otolaryngologists as posterior laryngitis, globus pharyngeus should be suspected as LPR-related diseases. In this multi-center trial, we tried to evaluate the effect of cisapride(10mg tid) on LPR-related symptoms as the part I study(CIS-KOR-051) in 19 centers, and as the part II study(CIS-KOR-052) comparative evaluation of effect between cisapride(10mg tid) and ranitidine(150mg bid) on LPR-related symptoms in 4 centers. In part I study, efficacy of cisapride on LPR-related symptoms after 4 weeks was 53.5% and that of after 8weeks was 77.9% in per protocol(PPA) analysis group. In part II study, efficacy of the cisapride was much better than that of ranitidine not only from 8 weeks trial(p<0.001) but also from 4 weeks trial(p<0.021) in PPA group. In the multiple logistic regression analysis among the parameters which affect the efficacy of the treatment, cisapride prescribed group showed 10 times greater than that of ranitidine prescribed group(p<0.0001, Odds ratio : 10) in PPA group. LPR was proved by 24Hr double probe pHmetry in 13 patients out of 19 patients tested(68.4%). Thus these results indicated that inducing the improvement of motility functions could affect the amelioration of the LPR-related symptoms much better than reducing acid secretion from the stomach. And maybe it suggests that LPR-related symptoms mainly developed by the reduced motility functions of the esophagus and/or delayed gastric emptying.

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Analysis of the Numeric Rating Scale (NRS) Used in Clinical Studies Based on Randomized Controlled Studies (임상연구에서 사용되고 있는 NRS에 대한 분석 : 무작위대조군연구를 중심으로)

  • Lee, Chan;Cho, Im-hak;Heo, Gi-yoon;Kang, Hee-kyung;Kim, Min-hwa;Han, Chang-woo;Kim, So-yeon;Choi, Jun-yong;Park, Seong-ha;Yun, Young-ju;Hong, Jin-woo;Kwon, Jung-nam;Lee, In
    • The Journal of Internal Korean Medicine
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    • v.42 no.4
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    • pp.510-531
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    • 2021
  • Objectives: The purpose of this study was to review the status of numeric rating scale (NRS) usage and suggest the potential for use in multicenter retrospective studies of various diseases. Methods: Articles published from 2011 to 2021 that used the keywords "NRS", "Multi-center", and "RCT" were identified in foreign databases, including EMBASE, PubMed, CENTRAL. The articles were analyzed according to their use of "NRS" by symptoms and by disease group using the major classifications of the Korean Standard Classification of Diseases (KCD-7). Results: Classification by symptom in a total of 288 articles illustrates that the NRS was not only commonly used in pain evaluation but also for non-pain symptoms. In usage with non-pain symptoms, chief complaint of patients was the most common at 79%, and other factors included treatment satisfaction, evaluation of daily life, and sleep quality. In disease classification according to the KCD-7, the NRS was commonly used in connection with musculoskeletal and connective tissue diseases but was also utilized in various other disease groups. Conclusions: This study confirms usage of the NRS in multi-center RCTs, as the NRS was widely used in all types of diseases and symptoms. Considering the result and the advantages of the NRS, it is recommended for use as a daily evaluation tool for the collection of common data in multicenter retrospective studies.

Optimal Duration of Dual Antiplatelet Therapy after Stent-Assisted Coil Embolization of Unruptured Intracranial Aneurysms : A Prospective Randomized Multicenter Trial

  • Ban, Seung Pil;Kwon, O-Ki;Kim, Young Deok;Kim, Bum-Tae;Oh, Jae Sang;Kim, Kang Min;Kim, Chang Hyeun;Kim, Chang-Hyun;Choi, Jai Ho;Kim, Young Woo;Lim, Yong Cheol;Byoun, Hyoung Soo;Park, Sukh Que;Chung, Joonho;Park, Keun Young;Park, Jung Cheol;Kwon, Hyon-Jo;Korean NeuroEndovascular Society,
    • Journal of Korean Neurosurgical Society
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    • v.65 no.6
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    • pp.765-771
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    • 2022
  • Objective : Stent-assisted coil embolization (SAC) has been increasingly used to treat various types of intracranial aneurysms. Delayed thromboembolic complications are major concerns regarding this procedure, so dual antiplatelet therapy with aspirin and clopidogrel is needed. However, clinicians vary the duration of dual antiplatelet therapy after SAC, and no randomized study has been performed. This study aims to compare the safety and efficacy of long-term (12 months) dual antiplatelet therapy and short-term dual antiplatelet therapy (6 months) after SAC for patients with unruptured intracranial aneurysms (UIAs). Methods : This is a prospective, randomized and multicenter trial to investigate the optimal duration of dual antiplatelet therapy after SAC in patients with UIAs. Subjects will receive dual antiplatelet therapy for 6 months (short-term group) or 12 months (long-term group) after SAC. The primary endpoint is the assessment of thromboembolic complications between 1 and 18 months after SAC. We will enroll 528 subjects (264 subjects in each group) and perform 1 : 1 randomization. This study will involve 14 top-performing, high-volume Korean institutions specializing in coil embolization. Results : The trial will begin enrollment in 2022, and clinical data will be available after enrollment and follow-up. Conclusion : This article describes that the aim of this prospective randomized multicenter trial is to compare the effect of short-term (6 months) and long-term (12 months) dual antiplatelet therapy on UIAs in patients undergoing SAC, and to find the optimal duration.

Pediatric Inflammatory Bowel Disease: A Multicenter Study of Changing Trends in Argentina Over the Past 30 Years

  • Arcucci, Maria Soledad;Contreras, Monica Beatriz;Gallo, Julieta;Antoniska, Mariela Andrea;Busoni, Veronica;Tennina, Cecilia;D’Agostino, Daniel;Kakisu, Maria Hisae;Weyersberg, Christian;Orsi, Marina
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.25 no.3
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    • pp.218-227
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    • 2022
  • Purpose: To analyze the characteristics of pediatric inflammatory bowel disease (IBD) over the past three decades in Argentina and determine if there are differences between the first two decades and the past decade. Methods: We conducted a retrospective multicenter analytical study in children with IBD between 0 and 18 years of age diagnosed between 1987 and 2017 in three tertiary health centers in Argentina. The evaluation included clinical characterization, endoscopy, histology, and imaging data together with therapeutic strategies. The patients were divided into two groups: Group 1, diagnosed between 1987 and 2007, and Group 2, diagnosed between 2008 and 2017. Results: Of the 756 patients included, 409 (54%) had ulcerative colitis (UC), 250 (33%) had Crohn's disease (CD), and 97 (13%) had IBD-unclassified (IBD-U). The positive family history was 3.8%, which was more frequent among children under two years of age (6.7%). There were no significant differences in clinical presentation and extraintestinal manifestations between periods, with hepatic manifestations being the most frequent. In the last decade, we found an upward trend in CD, a downward trend in UC/IBD-U, even after adjustment for socioeconomic status, and a decrease of 50% in surgical treatments coinciding with the advent of biological therapy. Conclusion: This is the first multicenter cohort study in a Latin American country to describe clinical, endoscopic, and therapeutic data across the past 30-year period. Although CD was responsible for the overall increase in incidence, UC was still prevalent in this region.

Study on Methods for Sasang Constituion Diagnosis (사상체질진단 방법론 연구)

  • Kim Jon-Won;Lee Eui-Ju;Kim Kyn-Kon;Kim Jong-Yeol;Lee Yong-Tae
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.19 no.6
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    • pp.1471-1474
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    • 2005
  • Sasang constitution medicine is to do different treatment accordining to sasang constitution. Therefore, the constitution diagnosis in the Sasang constitution medicine is very important thing. The Process of Sasang constitution diagnosis Is difficult thing, because of consuming much time, making every effort. It is apt to be subjective tendency. So it need to make objective method. The QSCC II (Questionnaire of Sasang Constitution Classification II ) have several problems- can't do diagnosis of Taeyangin, the accuracy rate of Sasang constitution diagnosis is not high (probably 60%), and so on. So, we need the new methods for the Sasang constitution Diagnosis. We will modify the problems of QSCC II. The First is the problems of the study execution process, not-multicenter study, a low data, the absent of Taeyangin cases. So, we have to do the multicenter study. The Second is the problems of a query and the method of statistics analysis. We will modify the problems of self-report Questionnaire. That is the problems of self-report Questionnaire, the lack of objective estimation( body type, personal appearance, etc), the absent of the estimation on typical or non-typical type constitution. We modified the problems of QSCC II. Therefore we made the new self-report Questionnaire for patients. We modified the problems of self-report Questionnaire. Therefore we made the new Constituion diagnosis Questionnaire for doctors. We develop the Questionnaire of two ways for the Sasang constitution Diagnosis. The one is the new self-report Questionnaire for patients. The other is the new Constitution diagnosis Questionnaire for doctors. We have to melt down the Questionnaire of two ways for the Sasang constitution Diagnosis.

Do Degree Programs Affect Health Profession Students' Attitudes and Opinions Toward Vaccinations? An Italian Multicenter Study

  • Voglino, Gianluca;Barbara, Andrea;Dallagiacoma, Giulia;Santangelo, Omar Enzo;Provenzano, Sandro;Gianfredi, Vincenza
    • Safety and Health at Work
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    • v.13 no.1
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    • pp.59-65
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    • 2022
  • Background: Healthcare workers' attitudes toward vaccination have been widely described in the literature, but a restricted amount of studies assessed healthcare students' knowledge, attitudes, and opinions on this issue. This study aimed to estimate the influence of a degree course on knowledge and immunization behavior among healthcare students and to compare medical students with students from other health profession degree programs to identify possible differences. Methods: A multicenter, cross-sectional study was performed in 2018 in 14 Italian Universities (3,131 students were interviewed). A validated questionnaire was used to assess knowledge, attitudes, and opinions toward vaccinations, with a specific focus on influenza vaccine and attitudes toward mandatory vaccination policies. Statistical software STATA® 14 was used. Results: Significant differences were recorded between medical students and other healthcare students. The intention to get vaccinated against influenza during the next season and having been vaccinated in the previous season was higher in the medical group (p < 0.001). In the group of students of other health professions, we registered a lower probability of identifying themselves as a high-risk group for contracting infectious diseases as a consequence of their profession and health status (aOR 0.49; CI95%: 0.40-0.60) and an increased likelihood of defining their level of knowledge on vaccine-preventable diseases and related vaccinations as "insufficient/sufficient/fair" (aOR 1.31; CI95%: 1.11-1.56). Conclusions: Results show several differences between medical students and students of other health professions when it comes to vaccination knowledge, attitudes, and perceptions, as well as a general low tendency to be vaccinated against influenza.

131I-Labeled-Metuximab Plus Transarterial Chemoembolization in Combination Therapy for Unresectable Hepatocellular Carcinoma: Results from a Multicenter Phase IV Clinical Study

  • Ma, Jun;Wang, Jian-Hua
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.17
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    • pp.7441-7447
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    • 2015
  • Objective: This study evaluated the safety and objective response of combining $^{131}I$-labeled-metuximab (Licartin) with transarterial chemoembolization (TACE) in the treatment of unresectable hepatocellular carcinoma (HCC). Materials and Methods: In a multicenter open-label clinical trial, 341 enrolled patients with stage III/IV HCC according to TNM criteria were nonrandomly assigned to a trial group (n=167) and a control group (n=174), undergoing TACE following hepatic intra-arterial injection of licartin or TACE alone from July 2007 to July 2009. Radiopharmaceutical distribution was evaluated. The primary endpoint was overall survival; secondary endpoints included time-to-progression (TTP), toxicity and adverse events (AEs). Results: The radiobiological distribution demonstrated better localization of licartin in liver tumors than other tissues (P<0.01). The organ absorbed doses to liver and red marrow were $3.19{\pm}1.01Gy$ and $0.55{\pm}0.22Gy$, respectively. The 1-year survival rate was significantly higher [79.47% vs. 65.59%, hazard ratio (HR), 0.598, P=0.041] and TTP significantly improved ($6.82{\pm}1.28$ vs. $4.7{\pm}1.14months$, P=0.037) compared with the control group. Patients at stage III achieved more benefit of one year survival than stage IV in the trial group (86.9% vs. 53.8%, P<0.001). There were significant different toxicities in leukocytopenia, thrombocytopenia and increased total bilirubin level [P<0.001, P=0.013, P<0.01, relative risk (RR) 1.63, 1.33, 1.43], but no differences in severe AEs of upper GI hemorrhage and severe liver dysfunction between the groups (5.39% vs. 2.3%, P=0.136). Conclusions: Owing to excellent tumor-targeting, promised efficacy and favourable toxicity profile, the novel combination therapy of licartin and TACE could be applied in patients with unresectable HCC.

MULTICENTER RETROSPECTIVE STUDY OF IMMEDIATE TWO DIFFERENT RBM SURFACED IMPLANT SYSTEMS AFTER EXTRACTION (발치 후 즉시 매식된 서로 다른 두종의 RBM표면 처리된 임플란트에 대한 다기관 후향적 임상연구)

  • Park, Hong-Ju;Kook, Min-Suk;Kim, Su-Gwan;Kim, Young-Kyun;Cho, Yong-Seok;Choi, Gab-Lim;Oh, Young-Hak;Oh, Hee-Kyun
    • Maxillofacial Plastic and Reconstructive Surgery
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    • v.30 no.3
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    • pp.258-265
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    • 2008
  • Purpose. This multicenter retrospective study was performed to evaluate the survival and success rates of immediate placement of USII and SSII Osstem implant (Osstem implant Co, Korea) on the maxillary and mandibular anterior and premolar areas. Materials and methods. Dental records were obtained in 37 patients who were treated with immediate implantation on the maxillary and mandibular anterior and premolar areas in 6 different clinics. The 98 implants were evaluated both clinically and radiographically using predefined success criteria. Results. There was no failed implant in all patients. The mean follow up period was 24.7 months (ranged from 12 to 58 months), and 25.1 months (ranged from 16 to 35 months) in USII and SSII implants, respectively. The crestal bone loss was 3 mm in 3 USII implants during 41 months, and in 1 SSII implant during 22 months. The overall success rate was 94.2% and 97.7% in USII and SSII implants, respectively. The age, gender, diameter, or length of implants, and type of surgery were not influenced to the success rate of immediate implantation. Conclusion. These results suggest that USII and SSII Osstem implant can be used successfully in immediate implantation on the maxillary and mandibular anterior and premolar areas.

Radiosurgery Compared with External Radiation Therapy as a Primary Treatment in Spine Metastasis from Hepatocellular Carcinoma : A Multicenter, Matched-Pair Study

  • Sohn, Seil;Chung, Chun Kee;Sohn, Moon Jun;Kim, Sung Hwan;Kim, Jinhee;Park, Eunjung
    • Journal of Korean Neurosurgical Society
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    • v.59 no.1
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    • pp.37-43
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    • 2016
  • Objective : The aim of this multicenter, matched-pair study was to compare the outcomes of stereotactic radiosurgery (SRS) and conventional external radiation therapy (RT) when used as a primary treatment in spine metastasis from hepatocellular carcinoma (HCC). Methods : From 2005 to 2012, 28 patients underwent SRS as the primary treatment in spine metastasis from HCC. Based on sex, age, number of spine metastasis, Child-Pugh classification, interval from original tumor to spine metastasis, and year of treatment, 28 patients who underwent RT were paired. Outcomes of interest were pain relief, progression free survival, toxicities, and further treatment. Results : The perioperative visual analog scale (VAS) decrease was larger in SRS group than in RT group, but the difference was not significant (3.7 vs. 2.8, p=0.13). When pain medication was adjusted, the number of patients with complete (n=6 vs.3) or partial (n=12 vs.13) relief was larger in SRS group than in RT group; however, the difference was not significant (p=0.83). There was no significant difference in progression free survival (p=0.48). In SRS group, 32.1% of patients had 1 or more toxicities whereas the percentage in RT group was 63.0%, a significant difference (p=0.04). Six SRS patients and 7 RT patients received further intervention at the treated segment. Conclusion : Clinical and radiological outcome were not significantly different between the two treatments. Toxicities, however, were more prevalent in the RT group.