• 제목/요약/키워드: multicenter

검색결과 366건 처리시간 0.023초

Recent Advances in Sentinel Node Navigation Surgery for Early Gastric Cancer

  • Eisuke Booka;Hiroya Takeuchi
    • Journal of Gastric Cancer
    • /
    • 제23권1호
    • /
    • pp.159-170
    • /
    • 2023
  • Maintaining the postoperative quality of life (QOL) while ensuring curability without overtreatment is important in the treatment of early gastric cancer. Postoperative QOL is anticipated to be maintained through minimally invasive function-preserving gastrectomy in early gastric cancer. The concept of the sentinel lymph node (SN) basin is essential to maintain the curability of early gastric cancer using minimally invasive function-preserving gastrectomy. However, additional resection after surgery is difficult to perform in gastric cancer. Thus, the SN basin theory is important. Recently, a multicenter randomized phase III trial in South Korea (SENORITA trial) proved that laparoscopic sentinel node navigation surgery (LSNNS) for stomach preservation results in better postoperative QOL compared with standard gastrectomy in patients with early gastric cancer. LSNNS contributes to patients' QOL based on the concept that curability is not impaired. A multicenter nonrandomized phase III trial is ongoing in Japan, and oncologic safety is expected to be demonstrated. LSNNS has been established as a treatment option for selected patients with early gastric cancer, and its application will become widespread in the future.

Prospective Multicenter Feasibility Study of Laparoscopic Sentinel Basin Dissection after Endoscopic Submucosal Dissection for Early Gastric Cancer: SENORITA 2 Trial Protocol

  • Eom, Bang Wool;Yoon, Hong Man;Min, Jae Seok;Cho, In;Park, Ji-Ho;Jung, Mi Ran;Hur, Hoon;Kim, Young-Woo;Park, Young Kyu;Nam, Byung-Ho;Ryu, Keun Won;Sentinel Node Oriented Tailored Approach (SENORITA) Study Group
    • Journal of Gastric Cancer
    • /
    • 제19권2호
    • /
    • pp.157-164
    • /
    • 2019
  • Purpose: Although standard radical gastrectomy is recommended after noncurative resection of endoscopic submucosal dissection (ESD) for early gastric cancer in most cases, residual tumor and lymph node metastasis have not been identified after surgery. The aim of this study is to evaluate the feasibility of sentinel node navigation surgery after noncurative ESD. Materials and Methods: This trial is an investigator-initiated, multicenter prospective phase II trial. Patients who underwent ESD for clinical stage T1N0M0 gastric cancer with noncurative resections were eligible. Qualified investigators who completed the prior phase III trial (SENORITA 1) are exclusively allowed to participate. In this study, 2 detection methods will be used: 1) intraoperative endoscopic submucosal injection of dual tracer, including radioisotope and indocyanine green (ICG) with sentinel basins detected using gamma-probe; 2) endoscopic injection of ICG, with sentinel basins detected using a fluorescence imaging system. Standard laparoscopic gastrectomy with lymphadenectomy will be performed. Sample size is calculated based on the inferior confidence interval of the detection rate of 95%, and the calculated accrual is 237 patients. The primary endpoint is detection rate, and the secondary endpoints are sensitivity and postoperative complications. Conclusions: This study is expected to clarify the feasibility of laparoscopic sentinel basin dissection after noncurative ESD. If the feasibility is demonstrated, a multicenter phase III trial will be initiated to compare laparoscopic sentinel node navigation surgery versus laparoscopic standard gastrectomy in early gastric cancer after endoscopic resection.

Association Between Insomnia and Constipation: A Multicenter Three-year Cross-sectional Study Using Shift Workers' Health Check-up Data

  • Yun, Byung-Yoon;Sim, Juho;Yoon, Jin-Ha;Kim, Sung-Kyung
    • Safety and Health at Work
    • /
    • 제13권2호
    • /
    • pp.240-247
    • /
    • 2022
  • Background: Although insomnia and constipation are highly prevalent worldwide, studies examining a possible association between them are lacking. We examined the relationship between insomnia and constipation in shift workers who have a high prevalence of insomnia and other diseases. Methods: This study had a multicenter cross-sectional design and conducted using health examination data including self-reported questionnaires. In total, 12,879 and 4,650 shift workers were enrolled in Severance Hospital and Wonju Severance Hospital, respectively, during 2015-2017. Multivariate logistic regression models and subgroup analysis were performed in each center with the same protocol, using a common data model. Results: The mean age of the total population was 44.35 (standard deviation = 8.75); the proportion of males was 56.9%. Female sex, being underweight and non-smoker were strongly associated with an increased risk of constipation symptom (p < 0.001). Pooled odds ratios (ORs) were calculated using ORs of both centers with weights; there was a significant dose-response relationship (sub-threshold 1.76 [95% confidence interval [CI] 1.62-1.91]; moderate 2.28 [95% CI 2.01-2.60]; severe 4.15 [95% CI 3.18-5.41] in the final model, p for trend < 0.001). Subgroup analysis performed by stratifying sex and pooled ORs showed a similar trend to that of the entire group. Conclusion: We observed a strong correlation between insomnia and constipation in this population. Our findings may help in formulating guidelines and policies to improve quality of life in shift workers through the management of sleep quality and proper bowel function. This study is the first to report this relationship among people working in shifts.

갱년 및 폐경 후 여성의 안면홍조에 대한 침 치료 다기관 임상연구 : 수행보고 및 방법론적 교훈 (Methodologic Lessons Learned from Multicenter, Randomized, Controlled Clinical Trial of Acupuncture for Hot Flashes in Peri- and Postmenopausal Women)

  • 김건형;김동일;황덕상;이진무;김형준;윤현민;정희정;강경원;이명수;최선미
    • 대한한방부인과학회지
    • /
    • 제23권1호
    • /
    • pp.42-52
    • /
    • 2010
  • Purpose: This report aims to administer methodologic issues around recently conducted multicenter study for evaluating the effects of acupuncture on menopusal hot flashes and discuss practical issues for further implementation of acupuncture clinical trial for hot flashes. Methods: Study process were mentioned, and issues related to avoiding risk of bias, designing appropriate control group, optimal outcome measurement, potential different effects of menopausal status on study outcomes, and suggestions for developing future clinical trials are discussed. Results: Shortcomings of our multicenter study include lack of allocation concealment and assessor blinding, subjective outcome measurement, short-term follow-up, and fixed acupuncture regimen despite pragmatic purpose of this study. Improving trial design, using objective or validated outcomes, assessing long-term effects of acupuncture, and individualizing acupuncture regimen are needed in future clinical trials. Conclusion: We expect these practical discussions to enable researchers to plan and develop future well-designed clinical trials for evaluating the effects of acupuncture on hot flashes or other women's health issues.

Treatment of Unruptured Intracranial Aneurysms in South Korea in 2006 : A Nationwide Multicenter Survey from the Korean Society of Cerebrovascular Surgery

  • Kim, Jeong-Eun;Lim, Dong-Jun;Hong, Chang-Ki;Joo, Sung-Pil;Yoon, Seok-Mann;Kim, Bum-Tae
    • Journal of Korean Neurosurgical Society
    • /
    • 제47권2호
    • /
    • pp.112-118
    • /
    • 2010
  • Objective : There have been no clinical studies regarding the epidemiology and treatment outcome for unruptured intracranial aneurysm (UIA) in South Korea yet. Thus, The Korean Society of Cerebrovascular Surgery (KSCVS) decided to evaluate the clinical and epidemiological characteristics, and outcome of the treatment of UIA in 2006, using the nationwide multicenter survey in South Korea. Methods : A total of 1,696 cases were enrolled retrospectively over one year at 48 hospitals. The following data were obtained from all patients : age, sex, presence of symptoms, location and size of the aneurysm, treatment modality, presence of risk factors for stroke, and the postoperative 3D-day morbidity and mortality. Results : The demographic data showed female predominance and peak age of seventh and sixth decades. Supraclinoid internal carotid artery was the most common site of aneurysms with a mean size of 5.6 mm. Eight-hundred-forty-six patients (49.9%) were treated with clipping, 824 (48.6%) with coiling, and 26 with combined method. The choice of the treatment modalities was related to hospital (p=0.000), age (p=0.000), presence of symptom (p=0.003), and location of aneurysm (p=0.000). The overall 30-day morbidity and mortality were 7.4% and 0.3%, respectively. The 30-day mortality was 0.4% for clipping and 0.2% for coiling, and morbidity was 8.4% for clipping and 6.3% for coiling. Age (p=0.010), presence of symptoms (p=0.034), size (p=0.000) of aneurysm, and diabetes mellitus (p=0.000) were significant prognostic factors, while treatment modality was not. Conclusion : This first nation-wide multicenter survey on UIAs demonstrates the epidemiological and clinical characteristics, outcome and the prognostic factors of the treatment of UIAs in South Korea. The 30-day postoperative outcome for UIAs seems to be reasonable morbidity and mortality in South Korea.

체질정보은행 구축현황에 관한 소고 (An Overview on the Construction of Korea Constitutional Multicenter Bank for Sasang Constitutional Medicine)

  • 백영화;진희정;김호석;장은수;이시우
    • 사상체질의학회지
    • /
    • 제24권2호
    • /
    • pp.47-53
    • /
    • 2012
  • 1. Objectives : The aim of the present study was to describe the Korea Constitutional Multicenter Bank (KCMB), which was various clinical data bank for scientific advancement of constitutional diagnosis and treatment. 2. Methods and Results : The KCMB is based on the 28 multi-institute cooperative clinical research networks including domestic and international institute. Since the KCMB was founded in 2006, data have been accumulated from 10,412 subjects. The KCMB consists of three parts: The clinical constitutional data, the measurement data, and the biological data. The method of data entry is via web based electronic Case Report From (eCRF). The eCRF has been developed and programed to ensure the efficient entry of data. We also developed coding manual, ongoing quality control assessment to obtain high-quality data. 3. Conclusions : The KCMB with various data contribute to providing the scientification of Sasang Constitutional Medicine.

COVID-19 and Cancer: Questions to Be Answered

  • Hong, Young Seon
    • Journal of Hospice and Palliative Care
    • /
    • 제24권1호
    • /
    • pp.66-68
    • /
    • 2021
  • The World Health Organization (WHO) declared the coronavirus disease 2019 (COVID-19) outbreak to be a pandemic on March 12, 2020. In Korea, there have been 24,027 confirmed cases of COVID-19 and 420 deaths as of October 3, 2020. The clinical spectrum of COVID-19 ranges from asymptomatic infection to death. Cancer care in this pandemic has radically changed. The literature was reviewed. The COVID-19 pandemic has made it urgently necessary to profoundly re-organize cancer patients' care without compromising cancer outcomes. Several important questions in regard to COVID-19 infection in cancer patients have emerged. Are patients with cancer at a higher risk of COVID-19 infection? Are they at an increased risk of mortality and severe illness when infected with COVID-19? Does anticancer treatment affect the course of COVID-19? Based on the existing research, cancer patients with immunosuppression are vulnerable to COVID-19 infection, and cancer patients are more likely to experience severe COVID-19. However, chemotherapy and major surgery do not seem to be predictors of hospitalization or severe disease. Korean background data on patients with cancer and COVID-19 are lacking. Prospective multicenter studies on the outcomes of patients with cancer and COVID-19 should be conducted.

한국의 대상 포진 관련 전구 증상의 특징 (The characteristics of zoster-associated prodromal symptoms in Korea)

  • 김연동;이공희;이철형
    • 한국융합학회논문지
    • /
    • 제12권8호
    • /
    • pp.327-333
    • /
    • 2021
  • 대상포진 환자의 대상포진 연관통증은 발진이 치유된 후에도 수년 동안 발생하여 오랫동안 지속될 수 있다. 이 경우 환자는 포진 후 신경통이 있는 것으로 진단된다. 대상포진의 전구 증상은 지속적이거나 간헐적인 통증과 함께 나타날 수 있으며 종종 다른 증상을 동반하여 오진 및 부적절한 치료를 초래한다. 이 연구의 목적은 국내 다기관 연구를 통해 대상포진 연관통증의 전구 증상 특성을 조사하는 것이다.