• Title/Summary/Keyword: Interventional study

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Review of Registration of Interventional Studies of Children and Adolescents in Korea (소아청소년 대상 중재연구의 등록 현황 - CRIS 등록부를 중심으로 -)

  • Lee, Yoo Been;Lee, Ju Ah;Lee, Hye Lim
    • The Journal of Pediatrics of Korean Medicine
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    • v.33 no.1
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    • pp.17-33
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    • 2019
  • Objectives The purpose of this study is to investigate the current status of registration of interventional studies focusing on children and adolescents in South Korea and the status of Korean medicine interventional studies through Clinical Research Information Service (CRIS). Methods CRIS was used to search interventional clinical researches which were registered from May, 2010 to October, 2018. Key words of 'child', 'children', 'adolescents', 'infant', 'toddler', 'elementary school student', 'middle and high school', 'middle school student', and 'high school student' were used. Results A total of 37 intervention clinical studies were selected. To identify the trends, years of registration in the CRIS, intervention types, disease categories, recruitment status, phase, institutions responsible for the research, consent, compensation and safety investigation were analyzed. Conclusions This study shows the current state of registration of interventional studies in children and adolescents in Korea. Since interventional studies in children and adolescents are essential for providing safe and effective treatment, further interventional studies, Korean medicine interventional studies and ethical considerations are needed.

Factors Associated with Psychological Characteristics in Patients with Hepatic Malignancy before Interventional Procedures

  • Wang, Zi-Xuan;Yuan, Chang-Qing;Guan, Jun;Liu, Si-Liang;Sun, Chun-Hui;Kim, Seong-Hwan
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.1
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    • pp.309-314
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    • 2012
  • Objective: To investigate the psychological characteristics of hepatic malignancy patients before interventional procedures and assess associations with related factors. Methods: Two hundred and thirteen patients requiring interventional procedure for hepatic malignancy were asked to complete a survey of health knowledge and psychological symptom on health knowledge questionnaire and SCL-90 before interventional procedure. Logistic regression analysis was employed to determine the association of various demographic, clinical and health knowledge factors with the presence of psychological symptoms in patients. Results: Eight psychological symptom scores, i.e. somatization, obsessive-compulsive tendencies, depression, anxiety, hostility, phobia, paranoid ideations and psychotic states, were significantly higher than the normal range (P< 0.001). Of 213 cases in the study, 49 families (23.00%) concealed the diagnoses of hepatic carcinoma from patients; 135 patients (63.38%) described the prognosis of the disease correctly. It was demonstrated that the correlations between psychological symptoms and related factors, i.e. age, gender, education, interventional procedure times and health knowledge, were statistically significant (P<0.05). Conclusion: Psychological distress is severe in hepatic malignancy patients before interventional procedures. Age, gender, education, interventional procedure times and health knowledge are associated with psychological symptoms which are significant different from the normal range in Chinese.

Microwave Ablation Treatment of Liver Cancer with a 2,450-MHz Cooled-shaft Antenna: Pilot Study on Safety and Efficacy

  • Jiao, De-Chao;Zhou, Qi;Han, Xin-Wei;Wang, Ya-Feng;Wu, Gang;Ren, Jian-Zhuang;Wang, Yan-Li;Ding, Peng-Xu;Ma, Ji;Fu, Ming-Ti
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.2
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    • pp.737-742
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    • 2012
  • To evaluate efficacy of microwave ablation in a primary clinical study, sixty patients (44 men, 16 women; mean age 53 years) with 96, 1-8 cm (mean $3.20{\pm}0.17$ cm) liver cancers were treated with 2,450-MHz internally cooled-shaft antenna. Complete ablation (CA) and local tumor progression (LTP) rates as well as complications were determined. CA rates in small (< 3.0 cm), intermediate (3.1-5.0 cm) and large (5.1-8.0 cm) liver cancers were 96.4% (54/56), 92.3% (24/26) and 78.6% (11/14), respectively. During a mean follow-up period of $17.17{\pm}6.52$ months, LTP occurred in five (5.21%) treated cases. There was no significant difference in the CA and LTP rates between the HCC and liver metastasis patient subgroups (P<0.05). Microwave ablation provides a reliable, efficient, and safe technique to perform hepatic tumor ablation.

Radiation Exposure to Physicians During Interventional Pain Procedures

  • Kim, Tae-Wan;Jung, Jang-Hwan;Jeon, Hyun-Joo;Yoon, Kyung-Bong;Yoon, Duck-Mi
    • The Korean Journal of Pain
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    • v.23 no.1
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    • pp.24-27
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    • 2010
  • Background: Fluoroscopy has been an integral part of modern interventional pain management. Yet fluoroscopy can be associated with risks for the patients and clinicians unless it is managed with appropriate understanding, skill and vigilance. Therefore, this study was designed to determine the amount of radiation received by a primary operator and an assistant during interventional pain procedures that involve the use of fluoroscopy. Methods: In order to examine the amount of radiation, the physicians were monitored by having them wear three thermoluminescent badges during each single procedure, with one under a lead apron, one under the apron collar and one on the leg during each single procedure. The data obtained from each thermoluminescent badge was reviewed from September 2008 to November 2008 and the annual radiation exposure was subsequently calculated. Results: A total of 505 interventional procedures were performed with C-arm fluoroscopy during three months. The results of this study revealed that the annual radiation exposure was relatively low for both the operator and assistant. Conclusions: With proper precautions, the use of fluoroscopy during interventional pain procedures is a safe practice.

Evaluation of Diagnostic Reference Level in Interventional Procedures (인터벤션시술 진단참고수준 평가)

  • Kang, Byung-Sam;Park, Hyung-Shin
    • Journal of radiological science and technology
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    • v.44 no.5
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    • pp.451-457
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    • 2021
  • Recently, the number of interventional procedures has increased dramatically as an alternative of invasive surgical procedure and patient radiation exposure is also increasing accordingly. In this study, we evaluated the patient dose of major interventional procedures nationwide and we established our Korean database. With these results, we tried to suggest the reference dose level for major interventional procedures. We evaluated patent dose data in the field of interventional radiology from foreign countries. Measurement of radiation dose exposure for 11 major interventional procedures was conducted using embedded DAP meters in 10,006 patients from 47 hospitals, and reference level of each interventional procedure was suggested. The DRLs of each intervenional procedure are as follows: TACE 206(Gy·cm2), AVF 12(Gy·cm2), LE intervention 43(Gy·cm2), TFCA 122(Gy·cm2), Cerebral aneurysm coil embolization 214(Gy·cm2), PTBD 22(Gy·cm2), Biliary stent 60(Gy·cm2), PCN 7(Gy·cm2), Hickman catheter 2.1(Gy·cm2), Chemoport 1.4(Gy·cm2), BAE 104(Gy·cm2). Compared with the previously established DRL in 2012, the radiation dose decreased in all 10 interventional procedures. In the future, continuous publicity and education on the radiation dose reduction will be needed.

A Study on the Interventional Needs for Relapse Pevention Program Among Adult Substance Abusers (성인 약물남용자의 예방 교육프로그램 개발을 위한 교육요구도 분석 -성인 수강명령 약물사범을 중심으로-)

  • 장진경
    • Journal of the Korean Home Economics Association
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    • v.38 no.6
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    • pp.81-100
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    • 2000
  • The purpose of this study was to develop the framework for the relapse prevention program. The study examined interventional needs for a relapse prevention program among adult substance abusers. The total of 107 adult substance abusers were surveyed and asked about their interventional needs for the relapse prevention program. The questionnaire was developed by the researcher on the basis of several theories such as problem behavior theory, ecologica1-developmental theory, social support theory, and coping theory. Results showed that admit substance abusers wanted the program to deal with such issues related with individual, family, social skills, and drugs. The implications of study findings were discussed.

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Assessment of Occupational Dose to the Staff of Interventional Radiology Using Monte Carlo Simulations (몬테카를로 방법을 이용한 중재방사선시술자에 대한 선량평가)

  • Lim, Young-Khi
    • Journal of Radiation Protection and Research
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    • v.39 no.4
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    • pp.213-217
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    • 2014
  • Medical operations and diagnosis using interventional radiology techniques have been increased. The management and monitoring of occupational radiation exposure to the staff of interventional radiology become important, specially because they stand in close proximity to the patient. The operational radiation protection quantity, Hp(10) which can be obtained from personal dosimeter do not always represent the effective dose to the staff. So, in this study, to estimate the critical organ doses to the staff of interventional radiology, Monte Carlo calculations with mathematical human phantom and dose measurements with personal dosimeters were carried out for the major interventional radiology procedures using C-arm. Results showed that the values of Hp(10) measured by personal dosimeters were higher than critical organ doses which were calculated. And the calculated dose to thyroids was much higher than those of other critical organ doses. For the proper radiation protection of the medical staff of interventional radiology, additional radiation protection for thyroids as well as for whole body shielding like wearing a lead apron should be considered.

Recent advances in pediatric interventional cardiology

  • Kim, Seong-Ho
    • Clinical and Experimental Pediatrics
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    • v.60 no.8
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    • pp.237-244
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    • 2017
  • During the last 10 years, there have been major technological achievements in pediatric interventional cardiology. In addition, there have been several advances in cardiac imaging, especially in 3-dimensional imaging of echocardiography, computed tomography, magnetic resonance imaging, and cineangiography. Therefore, more types of congenital heart diseases can be treated in the cardiac catheter laboratory today than ever before. Furthermore, lesions previously considered resistant to interventional therapies can now be managed with high success rates. The hybrid approach has enabled the overcoming of limitations inherent to percutaneous access, expanding the application of endovascular therapies as adjunct to surgical interventions to improve patient outcomes and minimize invasiveness. Percutaneous pulmonary valve implantation has become a successful alternative therapy. However, most of the current recommendations about pediatric cardiac interventions (including class I recommendations) refer to off-label use of devices, because it is difficult to study the safety and efficacy of catheterization and transcatheter therapy in pediatric cardiac patients. This difficulty arises from the challenge of identifying a control population and the relatively small number of pediatric patients with congenital heart disease. Nevertheless, the pediatric interventional cardiology community has continued to develop less invasive solutions for congenital heart defects to minimize the need for open heart surgery and optimize overall outcomes. In this review, various interventional procedures in patients with congenital heart disease are explored.

The Analysis of Registration Status of Interventional Clinical Trials for Children and Adolescents with Chronic Cough - Focused on WHO ICTRP - (소아 청소년 만성기침 환자를 대상으로 한 중재 임상시험 등록 현황 분석 - WHO ICTRP를 중심으로 -)

  • Jeong Yoon Kyoung;Choi Seo Yeon;Bang Miran;Lee Jun-Hwan;Lee Boram;Chang Gyu Tae
    • The Journal of Pediatrics of Korean Medicine
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    • v.37 no.3
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    • pp.75-93
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    • 2023
  • Objectives We aimed to analyze the registration status of interventional clinical trials in children and adolescents with chronic cough. Methods All interventional clinical trials registered up to 3 July, 2023 on the international clinical trial registry platform (ICTRP) of the World Health Organization (WHO) were analyzed. Information was extracted including study design, interventions, inclusion and exclusion criteria, and outcome indicators. Results A total of 18 interventional clinical trials were analyzed. For study design, multicentre trials, randomized allocation, parallel group design and phase 4 trials were the most frequently reported. Blinding was used in 44.4% and informed consents were obtained from 61.1%. For intervention, drugs were used in 61.1%, using placebo control group in 27.8%. Quality of life questionnaires were most frequently reported in 50% as the primary outcome, and adverse events were the most as the secondary outcome. In most cases, the assessment timepoints were after two weeks. Conclusions Based on the characteristics of clinical trial design analyzed in this study, it is necessary to design traditional Korean medicine clinical trials with improved quality and accuracy of information.

Sorafenib Continuation after First Disease Progression Could Reduce Disease Flares and Provide Survival Benefits in Patients with Hepatocellular Carcinoma: a Pilot Retrospective Study

  • Fu, Si-Rui;Zhang, Ying-Qiang;Li, Yong;Hu, Bao-Shan;He, Xu;Huang, Jian-Wen;Zhan, Mei-Xiao;Lu, Li-Gong;Li, Jia-Ping
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.7
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    • pp.3151-3156
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    • 2014
  • Background: Sorafenib is a promising drug for advanced hepatocellular carcinoma (HCC); however, treatment may be discontinued for multiple reasons, such as progressive disease, adverse events, or the cost of treatment. The consequences of sorafenib discontinuation and continuation are uncertain. Materials and Methods: We retrospectively analyzed 88 HCC patients treated with sorafenib from July 2007 to January 2013. Overall survival (OS), post-disease progression overall survival (pOS), and time to disease progression (TTP) were compared for survival analysis. Cox proportional hazard regression was performed to assess the effect of important factors on OS in the overall patient population and on pOS in patients who continued sorafenib treatment. Results: Sorafenib was discontinued and continued in 24 and 64 patients, respectively. The median OS (355 vs 517 days respectively; p=0.015) and median post-PD OS (260 vs 317 days, respectively; p=0.020) were statistically different between the discontinuation and continuation groups. Neither the median time to first PD nor the time to second PD were significantly different between the 2 groups. In the discontinuation group, 3 of the 24 patients (12.5%) suffered disease outbreaks. In Cox proportional hazard regression analysis after correction for confounding factors, BCLC stage (p=0.002) and PD site (p=0.024) were significantly correlated with pOS in patients who continued sorafenib treatment. Conclusions: Sorafenib discontinuation may cause HCC flares or outbreaks. It is advisable to continue sorafenib treatment after first PD, particularly in patients with Barcelona Clinic Liver Cancer stage B disease or only intrahepatic PD.