• 제목/요약/키워드: Multicenter

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Concordance of Three International Guidelines for Thyroid Nodules Classified by Ultrasonography and Diagnostic Performance of Biopsy Criteria

  • Younghee Yim;Dong Gyu Na;Eun Ju Ha;Jung Hwan Baek;Jin Yong Sung;Ji-hoon Kim;Won-Jin Moon
    • Korean Journal of Radiology
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    • 제21권1호
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    • pp.108-116
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    • 2020
  • Objective: To investigate the concordance of three international guidelines: the Korean Thyroid Association/Korean Society of Thyroid Radiology, American Thyroid Association, and American College of Radiology for thyroid nodules classified by ultrasonography (US) and the diagnostic performance of simulated size criteria for malignant biopsies. Materials and Methods: A total of 2586 thyroid nodules (≥ 1 cm) were collected from two multicenter study datasets. The classifications of the thyroid nodules were based on three different guidelines according to US categories for malignancy risk, and the concordance rate between the different guidelines was calculated for the classified nodules. In addition, the diagnostic performance of criteria related to four different simulated biopsy sizes was evaluated. Results: The concordance rate of nodules classified as high- or intermediate-suspicion was high (84.1-100%), but low-suspicion or mildly-suspicious nodules exhibited relatively low concordance (63.8-83.8%) between the three guidelines. The differences in sensitivity, specificity, and accuracy between the guidelines were 0.7-19.8%, 0-40.9%, and 0.1-30.5%, respectively, when the original biopsy criteria were applied. The differences decreased to 0-5.9%, 0-10.9%, and 0.1-8.2%, respectively, when simulated, similar biopsy size criteria were applied. The unnecessary biopsy rate calculated with the original criteria (0-33.8%), decreased with the simulated biopsy size criteria (0-8.7%). Conclusion: We found a high concordance between the three guidelines for high- or intermediate-suspicion nodules, and the diagnostic performance of the biopsy criteria was approximately equivalent for each simulated size criterion. The difference in diagnostic performance between the three guidelines is mostly influenced by the various size thresholds for biopsies.

Radiologic Evaluation and Structured Reporting Form for Extrahepatic Bile Duct Cancer: 2019 Consensus Recommendations from the Korean Society of Abdominal Radiology

  • Dong Ho Lee;Bohyun Kim;Eun Sun Lee;Hyoung Jung Kim;Ji Hye Min;Jeong Min Lee;Moon Hyung Choi;Nieun Seo;Sang Hyun Choi;Seong Hyun Kim;Seung Soo Lee;Yang Shin Park;Yong Eun Chung;The Korean Society of Abdominal Radiology
    • Korean Journal of Radiology
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    • 제22권1호
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    • pp.41-62
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    • 2021
  • Radiologic imaging is important for evaluating extrahepatic bile duct (EHD) cancers; it is used for staging tumors and evaluating the suitability of surgical resection, as surgery may be contraindicated in some cases regardless of tumor stage. However, the published general recommendations for EHD cancer and recommendations guided by the perspectives of radiologists are limited. The Korean Society of Abdominal Radiology (KSAR) study group for EHD cancer developed key questions and corresponding recommendations for the radiologic evaluation of EHD cancer and organized them into 4 sections: nomenclature and definition, imaging technique, cancer evaluation, and tumor response. A structured reporting form was also developed to allow the progressive accumulation of standardized data, which will facilitate multicenter studies and contribute more evidence for the development of recommendations.

소아청소년 단순 비만에 대한 한약 및 약물 중재 임상시험 등록 현황 분석 - WHO ICTRP를 중심으로 - (The Analysis of Registration Status of Herbal Medicine and Medication Interventional Clinical Trials for Simple Obesity in Children and Adolescents -Focused on WHO ICTRP-)

  • 정윤경;최서연;방미란;이보람;장규태
    • 대한한방소아과학회지
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    • 제38권1호
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    • pp.55-77
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    • 2024
  • Objectives This study aimed to analyze the registration status and characteristics of clinical trials on herbal medicine (HM) and medication interventions for simple obesity in children and adolescents. Methods All interventional clinical trials registered in the International Clinical Trials Registry Platform of the World Health Organization until December 12, 2024, were collected. The study design, interventions, inclusion and exclusion criteria, and outcome measures were extracted. Results A total of 24 clinical trials (23 medications and 1 HM) were analyzed. The most common study designs were single-center, randomized controlled, parallel, and phase 2. Placebo controls were used in 87.5% of the studies, blinding was used in 79.1%, and quadruple blinding was the most common. Informed consent was obtained from 70.8% of the participants. Among the oral medications (66.6%), metformin was the most common (25%). Among the non-oral medications (29.1%), exenatide (Bydureon) was the most common intervention (42.8%). Body mass index was the most commonly reported primary outcome measure (79.1%), with most assessments performed at 6 months. Conclusions Based on the characteristics of the medication interventional clinical trial design analyzed in this study, additional high-quality multicenter traditional Korean medicine trials need to be designed in the future.

Prediction of lifespan and assessing risk factors of large-sample implant prostheses: a multicenter study

  • Jeong Hoon Kim;Joon-Ho Yoon;Hae-In Jeon;Dong-Wook Kim;Young-Bum Park;Namsik Oh
    • The Journal of Advanced Prosthodontics
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    • 제16권3호
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    • pp.151-162
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    • 2024
  • PURPOSE. This study aimed to analyze factors influencing the success and failure of implant prostheses and to estimate the lifespan of prostheses using standardized evaluation criteria. An online survey platform was utilized to efficiently gather large samples from multiple institutions. MATERIALS AND METHODS. During the one-year period, patients visiting 16 institutions were assessed using standardized evaluation criteria (KAP criteria). Data from these institutions were collected through an online platform, and various statistical analyses were conducted. Risk factors were assessed using both the Cox proportional hazard model and Cox regression analysis. Survival analysis was conducted using Kaplan-Meier analysis and nomogram, and lifespan prediction was performed using principal component analysis. RESULTS. The number of patients involved in this study was 485, with a total of 841 prostheses evaluated. The median survival was estimated to be 16 years with a 95% confidence interval. Factors found to be significantly associated with implant prosthesis failure, characterized by higher hazard ratios, included the 'type of clinic', 'type of antagonist', and 'plaque index'. The lifespan of implant prostheses that did not fail was estimated to exceed the projected lifespan by approximately 1.34 years. CONCLUSION. To ensure the success of implant prostheses, maintaining good oral hygiene is crucial. The estimated lifespan of implant prostheses is often underestimated by approximately 1.34 years. Furthermore, standardized form, online platform, and visualization tool, such as nomogram, can be effectively utilized in future follow-up studies.

The Dome Technique for Managing Massive Anterosuperior Medial Acetabular Bone Loss in Revision Total Hip Arthroplasty: Short-Term Outcomes

  • Tyler J. Humphrey;Colin M. Baker;Paul M. Courtney;Wayne G. Paprosky;Hany S. Bedair;Neil P. Sheth;Christopher M. Melnic
    • Hip & pelvis
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    • 제35권2호
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    • pp.122-132
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    • 2023
  • Purpose: The dome technique is a technique used in performance of revision total hip arthroplasty (THA) involving intraoperative joining of two porous metal acetabular augments to fill a massive anterosuperior medial acetabular bone defect. While excellent outcomes were achieved using this surgical technique in a series of three cases, short-term results have not been reported. We hypothesized that excellent short-term clinical and patient reported outcomes could be achieved with use of the dome technique. Materials and Methods: A multicenter case series was conducted for evaluation of patients who underwent revision THA using the dome technique for management of Paprosky 3B anterosuperior medial acetabular bone loss from 2013-2019 with a minimum clinical follow-up period of two years. Twelve cases in 12 patients were identified. Baseline demographics, intraoperative variables, surgical outcomes, and patient reported outcomes were acquired. Results: The implant survivorship was 91% with component failure requiring re-revision in only one patient at a mean follow-up period of 36.2 months (range, 24-72 months). Three patients (25.0%) experienced complications, including re-revision for component failure, inter-prosthetic dual-mobility dissociation, and periprosthetic joint infection. Of seven patients who completed the HOOS, JR (hip disability and osteoarthritis outcome score, joint replacement) survey, five patients showed improvement. Conclusion: Excellent outcomes can be achieved using the dome technique for management of massive anterosuperior medial acetabular defects in revision THA with survivorship of 91% at a mean follow-up period of three years. Conduct of future studies will be required in order to evaluate mid- to long-term outcomes for this technique.

독립적 검사 방법으로서의 확산강조 자기공명영상검사 (Diffusion-Weighted Imaging as a Stand-Alone Breast Imaging Modality)

  • 신희정;이수현;문우경
    • 대한영상의학회지
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    • 제82권1호
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    • pp.29-48
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    • 2021
  • 확산강조영상은 유방암의 진단과 스크리닝에 있어 독립적 검사 방법으로서의 기대되는 결과를 보여주는 빠른 비조영증강 검사 방법이다. 현재까지의 연구 결과 유방암 진단에 있어 독립적 검사 방법으로서 확산강조영상의 민감도는 역동적 조영증강 검사보다는 낮으나 유방촬영술보다는 높으며, 이로써 유방암 스크리닝에 대한 유용한 대안이 될 수 있을 것으로 보인다. 확산강조영상의 표준화된 영상 획득과 판독을 통해 영상 화질이 개선될 수 있고, 판독 결과의 다양성도 감소할 것으로 기대된다. 또한, 최신 기법과 후처리 기법을 사용한 고해상도 확산강조영상을 시행함으로써 1 cm 미만의 작은 암의 발견율을 증가시킬 수 있고, 가음성 및 가양성 결과를 감소시킬 것으로 보인다. 현재 한국에서 진행 중인 고위험군 여성에서의 확산강조영상 스크리닝에 대한 다기관 연구 결과가 나온다면 독립적 검사로서의 확산강조영상의 사용을 촉진시킬 수 있을 것으로 기대된다.

A Multicenter Pilot Study of Biliary Atresia Screening Using Digital Stool Color Imaging

  • Kannamon Waitayagitgumjon;Wannisa Poocharoen;Suchin Trirongjitmoah;Kriengsak Treeprapin;Arada Suttiwongsing;Thetiya Wirifai;Chira Trirongchitmoh;Pitiporn Tangkabuanbutr
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • 제27권3호
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    • pp.168-175
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    • 2024
  • Purpose: The presence of alcoholic stool in biliary atresia (BA) patients is the basis of a stool color card (SCC), a screening tool that has led to more patients receiving Kasai portoenterostomy earlier. This study aimed to evaluate the color image processing of stool images captured using smartphones. We propose that measuring digital color parameters is a more objective method for identifying BA stools and may improve the sensitivity of BA screening. Methods: A prospective study was conducted in five hospitals in Thailand between October 1, 2020, and December 31, 2021. Stools from infants presenting with jaundice, acholic stool, or dark-colored urine were photographed. Digital image color analysis was performed, and software was developed based on the color on the original SCC. Sensitivity and specificity for predicting BA stools were compared between the SCC and the software. Results: Of 33 infants eligible for data collection, 19 were diagnosed with BA. Saturation and blue were two potential digital color parameters used to differentiate BA stools. The receiver operating characteristic curve was used to determine the optimum cutoff point of both values, and when saturation ≤56 or blue ≥61 was set as a threshold for detecting BA stool, high accuracy was achieved at 81.8% and 78.8%, respectively. Conclusion: Digital image processing is a promising technology. With appropriate cutoff values of saturation in hue, saturation, value and blue in red, green, blue color models, BA stools can be identified, and equivocal-colored stools of non-BA patients can be differentiated with acceptable accuracy in infants presenting with jaundice.

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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    • 제56권1호
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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.

Detection of Malignant Primary Hepatic Neoplasms with Gadobenate Dimeglumine (Gd-BOPTA) Enhanced T1-Weighted Hepatocyte Phase MR Imaging: Results of Off-site Blinded Review in a Phase-II Multicenter Trial

  • Constantino S. Pena;Sanjay Saini;Richard L. Baron;Bernd A. Hamm;Giovanni Morana;Roberto Caudana;Andrea Giovagnoni;Andrea Villa;Alessandro Carriero;Didier Mathieu;Michael W. Bourne;Miles A. Kirchin;Gianpaolo Pirovano;Alberto Spinazzi
    • Korean Journal of Radiology
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    • 제2권4호
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    • pp.210-215
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    • 2001
  • Objective: To investigate the efficacy of gadobenate dimeglumine (GdBOPTA) enhanced MR imaging for the detection of liver lesions in patients with primary malignant hepatic neoplasms. Materials and Methods: Thirty-one patients with histologically proven primary malignancy of the liver were evaluated before and after administration of GdBOPTA at dose 0.05 or 0.10 mmol/kg. T1-weighted spin echo (T1W-SE) and gradient echo (T1W-GRE) images were evaluated for lesion number, location, size and confidence by three off-site independent reviewers and the findings were compared to reference standard imaging (intraoperative ultrasound, computed tomography during arterial portography or lipiodol computed tomography). Results were analyzed for significance using a two-sided McNemar's test. Results: More lesions were identified on Gd-BOPTA enhanced images than on unenhanced images and there was no significant difference in lesion detection between either concentration. The largest benefit was in detection of lesions under 1 cm in size (7 to 21, 9 to 15, 16 to 18 for reviewers A, B, C respectively). In 68% of the patients with more than one lesion, Gd-BOPTA increased the number of lesions detected. Conclusion: Liver MR imaging after Gd-BOPTA increases the detection of liver lesions in patients with primary malignant hepatic neoplasm.

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Covered self-expandable metallic stents versus plastic stents for endoscopic ultrasound-guided hepaticogastrostomy in patients with malignant biliary obstruction

  • Taro Shibuki;Kei Okumura;Masanari Sekine;Ikuhiro Kobori;Aki Miyagaki;Yoshihiro Sasaki;Yuichi Takano;Yusuke Hashimoto
    • Clinical Endoscopy
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    • 제56권6호
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    • pp.802-811
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    • 2023
  • Background/Aims: Covered self-expandable metallic stents (cSEMS) have become popular for endoscopic ultrasound-guided hepaticogastrostomy with transmural stenting (EUS-HGS). We compared the time to recurrent biliary obstruction (TRBO), complications, and reintervention rates between EUS-HGS using plastic stent (PS) and cSEMS in patients with unresectable malignancies at multicenter institutions in Japan. Methods: Patients with unresectable malignant biliary obstruction who underwent EUS-HGS between April 2015 and July 2020 at any of the six participating facilities were enrolled. Primary endpoint: TRBO; secondary endpoints: rate of complications other than recurrent biliary obstruction and technical success rate of reintervention were evaluated. Results: PS and cSEMS were used for EUS-HGS in 109 and 43 patients, respectively. The TRBO was significantly longer in the cSEMS group than in the PS group (646 vs. 202 days). Multivariate analysis identified two independent factors associated with a favorable TRBO: combined EUS-guided antegrade stenting with EUS-HGS and the use of cSEMS. No significant difference was observed in the rate of complications other than recurrent biliary obstruction between the two groups. The technical success rate of reintervention was 85.7% for PS and 100% for cSEMS (p=0.309). Conclusions: cSEMS might be a better option for EUS-HGS in patients with unresectable malignancies, given the longer TRBO.