• 제목/요약/키워드: Multicenter

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A Novel Implantable Cerebrospinal Fluid Reservoir : A Pilot Study

  • Byun, Yoon Hwan;Gwak, Ho Shin;Kwon, Ji-Woong;Kim, Kwang Gi;Shin, Sang Hoon;Lee, Seung Hoon;Yoo, Heon
    • Journal of Korean Neurosurgical Society
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    • 제61권5호
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    • pp.640-644
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    • 2018
  • Objective : The purpose of this pilot study was to examine the safety and function of the newly developed cerebrospinal fluid (CSF) reservoir called the V-Port. Methods : The newly developed V-Port consists of a non-collapsible reservoir outlined with a titanium cage and a connector for the ventricular catheter to be assembled. It is designed to be better palpated and more durable to multiple punctures than the Ommaya reservoir. A total of nine patients diagnosed with leptomeningeal carcinomatosis were selected for V-Port insertion. Each patient was followed up for evaluation for a month after the operation. Results : The average operation time for V-Port insertion was 42 minutes and the average incision size was 6.6 cm. The surgical technique of V-Port insertion was found to be intuitive by all neurosurgeons who participated in the pilot study. There was no obstruction or leakage of the V-Port during intrathecal chemotherapy or CSF drainage. Also, there were no complications including post-operative intracerebral hemorrhage, infection and skin problems related to the V-Port. Conclusion : V-Port is a safe and an easy to use implantable CSF reservoir that addresses problems of other implantable CSF reservoirs. Further multicenter clinical trial is needed to prove the safety and the function of the V-Port.

위식도 역류성 질환 관련 인후두성 역류(Laryngopharyngeal Reflux : LPR)증상을 호소하는 환자에서의 니자티딘의 치료효과 연구 (The Therapeutic Effects of Nizatidine in Gastroesophageal Disease with Laryngopharyngeal Reflux Symptoms: Observational Study)

  • 노영수;고중화;김광현;김명구;김병국;김성식;김영모;김영훈;김용복
    • 대한기관식도과학회지
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    • 제9권1호
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    • pp.67-74
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    • 2003
  • Larygopharyngeal reflux(LPR) is one form of the Gastroesophageal Reflux Diseases(GERD). It is known to cause various kinds of otolaryngologic symptoms such as hoarseness, globus sensation in throat, chronic throat clearing, and chronic cough, Disease entities diagnosed by otolaryngologists as posterior laryngitis, globus pharyngeus and reflux laryngitis should be suspected as LPR-related diseases. The nizatidine(AXID), as a Histamine H2-receptor antagonist, reduces gastric acid secretion and improves gastric motility function. Objectives : The effect of nizatidine using 150mg b.i.d was evaluated for symptom relief and improvement of laryngoscopic findings in patients with LPR. Materials and Methods : In 30 multicenter, observational trial performed nationalwidely in Korea. 308 patients with LPR symptom were observed to evaluate their symptoms and larygnoscopic findings after 4weeks, 8weeks, 12weeks of treatment with nizatidine. Results : The symptoms of LPR including globus sensation, chronic throat clearing and hoarseness, are reduced significantly after 4 weeks, 8weeks, and 12weeks of treatment(p<0.05). The laryngoscopic findings including diffuse erythema, edema and granulation are improved after nizatidine treatment(p<0.05). and the efficacy of nizatidine on LPR-related sympoms after 4 weeks is 88.6%, and those of after 8 weeks and 12weeks were 92.6%, and 99.1% in ITT(Intent To Treatment) group(p<0.05). And PPA(Per Protocol Analysis)group showed 93.7%, 97.3%, and 99.1% of efficacy after 4, 8, and 12 weeks of nizatidine treatment(p<0.05). Conclusion : These results indicate that in patient with LPR, nizatidine 150mg b.i.d treatment very effectively reduces LPR symptoms and improves laryngoscopic findings as well as reduces gastric acid secretion and improves gastric motility function.

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Outcomes of the Multimodal Treatment of Malignant Pleural Mesiothelioma: The Role of Surgery

  • Na, Bub-Se;Kim, Ji Seong;Hyun, Kwanyong;Park, In Kyu;Kang, Chang Hyun;Kim, Young Tae
    • Journal of Chest Surgery
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    • 제51권1호
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    • pp.35-40
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    • 2018
  • Background: The treatment of malignant pleural mesothelioma (MPM) is challenging, and multimodal treatment including surgery is recommended; however, the role of surgery is debated. The treatment outcomes of MPM in Korea have not been reported. We analyzed the outcomes of MPM in the context of multimodal treatment, including surgery. Methods: The records of 29 patients with pathologically proven MPM from April 1998 to July 2015 were retrospectively reviewed. The treatment outcomes of the surgery and non-surgery groups were compared. Results: The overall median survival time was 10.6 months, and the overall 3-year survival rate was 25%. No postoperative 30-day or in-hospital mortality occurred in the surgery group. Postoperative complications included tachyarrhythmia (n=4), pulmonary thromboembolism (n=1), pneumonia (n=1), chylothorax (n=1), and wound complications (n=3). The treatment outcomes between the surgery and non-surgery groups were not significantly different (3-year survival rate: 31.3% vs. 16.7%, respectively; p=0.47). In a subgroup analysis, there was no significant difference in the treatment outcomes between the extrapleural pneumonectomy group and the non-surgery group (3-year survival rate: 45.5% vs. 16.7%, respectively; p=0.23). Conclusion: Multimodal treatment incorporating surgery did not show better outcomes than non-surgical treatment. A nationwide multicenter data registry and prospective randomized controlled studies are necessary to optimize the treatment of MPM.

The safety and efficacy of EGF-based cream for the prevention of radiotherapy-induced skin injury: results from a multicenter observational study

  • Kang, Hyun-Cheol;Ahn, Seung-Do;Choi, Doo-Ho;Kang, Min Kyu;Chung, Woong-Ki;Wu, Hong-Gyun
    • Radiation Oncology Journal
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    • 제32권3호
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    • pp.156-162
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    • 2014
  • Purpose: This study was designed to evaluate the efficacy and safety of topically applied recombinant human epidermal growth factor (rhEGF) for the prevention of radiation-induced dermatitis in cancer patients. Materials and Methods: From December 2010 to April 2012, a total of 1,172 cancer patients who received radiotherapy (RT) of more than 50 Gy were prospectively enrolled and treated with EGF-based cream. An acute skin reaction classified according to the Radiation Therapy Oncology Group 6-point rating scale was the primary end point and we also assessed the occurrence of edema, dry skin, or pruritus. Results: The percentage of radiation dermatitis with maximum grade 0 and grade 1 was 19% and 58% at the time of 50 Gy, and it became 29% and 47% after completion of planned RT. This increment was observed only in breast cancer patients (from 18%/62% to 32%/49%). Adverse events related to the EGF-based cream developed in 49 patients (4%) with mild erythema the most common. Skin toxicity grade >2 was observed in 5% of the patients. Edema, dry skin, and pruritus grade ${\geq}3$ developed in 9%, 9%, and 1% of the patients, respectively. Conclusion: Prophylactic use of an EGF-based cream is effective in preventing radiation dermatitis with tolerable toxicity. Further studies comparing EGF cream with other topical agents may be necessary.

Multicenter Evaluation of Patients with Cutaneous Malignant Melanoma in Turkey: MELAS Study

  • Uysal-Sonmez, Ozlem;Tanriverdi, Ozgur;Esbah, Onur;Uyeturk, Ummugul;Helvaci, Kaan;Bal, Oznur;Yalcintas-Arslan, Ulku;Budakoglu, Burcin;Oksuzoglu, Berna
    • Asian Pacific Journal of Cancer Prevention
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    • 제14권1호
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    • pp.533-537
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    • 2013
  • Background: Malignant melanoma is a cancer that demonstrates rapid progression and atypical clinically features with a poor prognosis. Aim: This study was performed to determine the clinical characteristics and treatment outcomes of patients with malignant melanoma in Turkey. Methods: The medical records of 98 patients between 2007-2012 at our centers were retrieved from the patient registry. Overall survival (OS) was calculated using the Kaplan-Meier method. Results: In our study, with the median follow-up of all patients with cutaneous MM of 46.3 months, the median OS rate of all cases was 43.6 months and 5-year OS was 48.6%. However, five-year OS rates of patients with localized disease (stage I-II) and node involvement (stage III) were 60.3% and 39.6%, respectively. The median OS of stage IV patients was 8.7 months and 1-year OS rate was 26.2%. We showed that advanced stage, male gender, and advanced age in all patients with MM were significant prognostic factors of OS. Conclusions: Compared with the results of current studies from Western countries, we found similar findings concerning demographical features, histological variables and survival analyses for our patients with cutaneous MM in Turkey.

Factors Associated with Discontinuation of Complementary and Alternative Medicine among Korean Cancer Patients

  • Kim, So Young;Kim, Kyung Sook;Park, Jong Hyock;Shin, Ji-Yeon;Kim, Sung Kyeong;Park, Jae Hyun;Park, Eun Cheol;Seo, Hong Gwan
    • Asian Pacific Journal of Cancer Prevention
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    • 제14권1호
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    • pp.225-230
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    • 2013
  • Objectives: The purpose of this study was to determine patient characteristics and other factors associated with discontinuation of complementary and alternative medicine (CAM) among cancer patients in Korea. Methods: A national, multicenter, cross-sectional survey of cancer patients was performed in which 674 of 2,661 patients were analyzed for their use of CAM after cancer diagnosis. Multiple logistic regression was used to identify the factors related to CAM discontinuation. Results: Among the surveyed cancer patients, 25.3% (674 of 2,661) had used CAM, whereas 38.3% (258 of 674) of those with CAM experience had discontinued CAM therapy. The most frequently used form of CAM was herbs (43.5%). The major reasons for the discontinuation of CAM included absence of effects (23.9%), financial burden (22.9%), and physician opposition (13.7%). Other factors associated with the discontinuation of CAM included metastatic cancer (OR = 2.06), a long duration of cancer treatment (OR = 3.34), dissatisfaction (OR = 4.34), and side effects (OR = 4.23) of CAM therapy. Conclusions: For cancer patients to correctly employ CAM therapy, increase their satisfaction, and reduce their side effects, efforts should be made to analyze the cost effectiveness of CAM, and valid information must be provided to physicians and cancer patients.

A Multicenter Matched Case Control Study of Breast Cancer Risk Factors among Women in Karachi, Pakistan

  • Shamsi, Uzma;Khan, Shaista;Usman, Sheheryar;Soomro, Saleem;Azam, Iqbal
    • Asian Pacific Journal of Cancer Prevention
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    • 제14권1호
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    • pp.183-188
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    • 2013
  • Background: Breast cancer (BC), the most common female cancer in Pakistan, is associated with a very high mortality. However, the roles of individual risk factors for BC among Pakistani women are still controversial. To assess potential risk factors for BC, a matched case-control study was conducted in two tertiary care hospitals of Karachi, Pakistan. Materials and Methods: The study population included 297 pathologically confirmed incident cases of BC patients diagnosed between January 2009 and December 2010. 586 controls without any history of BC were matched on hospital and ${\pm}5$ years of ages. Results: Positive family history of BC (MOR=1.72; 95%CI: 1.10, 2.80 for first degree vs. none), single marital status (MOR=1.55; 95%CI: 1.10, 2.39 for single/divorced/widowed women vs. married women), older age at menopause (MOR=3.92; 95%CI: 2.52, 6.18 for menopausal women aged below 45 years, MOR=6.42; 95%CI: 3.47, 11.98 for menopausal women above 45 years of age compared with premenopausal women) conferred an increased risk of BC for women. Increasing parity decreased the risk of BC (MOR=0.90; 95%CI: 0.85, 0.97 for each live birth). Intake of Vitamin D supplements (MOR=0.30; 95%CI: 0.12, 0.81 for ${\leq}3$ years and MOR=0.27; 95%CI: 0.13, 0.56 for >3 years) was protective compared to non-users of Vitamin D. Conclusions: This study confirmed only few of the recognized risk factors in Pakistani women. The protective effect of Vitamin D is important from public health perspective and needs to be further explored through a randomized controlled trial.

The Association of Circumcision and Prostate Cancer: A Meta-Analysis

  • Li, Yu-dan;Teng, Yang;Dai, Yu;Ding, Hui
    • Asian Pacific Journal of Cancer Prevention
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    • 제17권8호
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    • pp.3823-3827
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    • 2016
  • Background: To investigate the association circumcision with prostate cancer. Materials and Methods: We searched PubMed, EMBASE, the Cochrane Library, and Chinese biomedicine literature database up to August 2015. All case-control studies were identified in which investigated the association circumcision with prostate cancer. Three authors independently assessed study quality and extracted data. All data were analyzed using RevMan 5.3 and STATA version 11.0. Results: Six case-control studies met the inclusion criteria. The pooled meta-analysis showed that there was a lower incidence of circumcision in prostate cancer patients compared with control (OR=0.90, 95% confidence interval [CI] 0.82-0.98, P=0.01). The results of meta-analysis also showed that no significant difference was found between circumcision and less aggressive prostate cancer (OR=0.93, 95% CI 0.83-1.04, P=0.19); however, there was a lower incidence of circumcision in more aggressive prostate cancer compared with control (OR =0.84, 95% CI 0.72-0.97, P=0.02). The Egger's results did not show any evidence of publication bias(P=0.798). Conclusions: In summary, within the limits of available data, male with circumcision appears to have a lower incidence of prostate cancer. In the future, high-quality multicenter studies are needed to thoroughly verify the outcome.

Outcome of complete acellular dermal matrix wrap with polyurethane implant in immediate prepectoral breast reconstruction

  • Naemonitou, Foteini;Mylvaganam, Senthurun;Salem, Fathi;Vidya, Raghavan
    • Archives of Plastic Surgery
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    • 제47권6호
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    • pp.567-573
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    • 2020
  • Background Polyurethane implants have been used on and off in breast reconstruction since 1991 while prepectoral breast reconstruction has gained popularity in recent times. In this study, we present our outcomes from the use of acellular dermal matrix (ADM) complete wrap with polyurethane implants in prepectoral breast reconstruction. Methods This is a retrospective review of prospectively maintained database from 41 patients receiving complete ADM wrap with prepectoral polyurethane implants over a 3-year period. Selection criteria were adapted from a previous study (4135 Trust Clinical Audit Database) evaluating prepectoral reconstruction with Braxon matrices. Patient demographics, operative data, surgical complications, and outcomes were collected and analyzed. Results A total of 52 implant reconstructions were performed in 41 patients with a mean follow-up of 14.3 months (range, 6-36 months). The overall reported complication rates including early (less than 6 weeks) and late complications. Early complications included two patients (4.9%) with wound dehiscence. One of which had an implant loss that was salvageable. Another patient (2%) developed red-breast syndrome and two women (4.9%) developed with seroma treated conservatively. Late complications included one patient (2%) with grade II capsular contraction, 12 patients with grade I-II rippling and two patients (4.9%) with grade III rippling. Conclusions We present our experience of prepectoral polyurethane implant using complete ADM wrap. This is one of the few papers to report on the outcome of the prepectoral use of polyurethane in immediate implant-based breast reconstruction. Our early observational series show satisfactory outcome and long-term results are warranted by a large multicenter study.

Docetaxel and Cisplatin in First Line Treatment of Patients with Unknown Primary Cancer: A Multicenter Study of the Anatolian Society of Medical Oncology

  • Demirci, Umut;Coskun, Ugur;Karaca, Halit;Dane, Faysal;Ozdemir, Nuriye Yildirim;Ulas, Arife;Baykara, Meltem;Benekli, Mustafa;Ozkan, Metin;Buyukberber, Suleyman
    • Asian Pacific Journal of Cancer Prevention
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    • 제15권4호
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    • pp.1581-1584
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    • 2014
  • Background: The overall prognosis for cancers of unknown primary (CUP) is poor, median overall survival (OS) being 6-12 months. We evaluated our multicentric retrospective experience for CUP administered docetaxel and cisplatin combination therapy. Materials and Methods: A total of 29 patients that were pathologically confirmed subtypes of CUP were included in the study. The combination of docetaxel ($75mg/m^2$, day 1) and cisplatin ($75mg/m^2$, day 1) was performed as a first line regimen every 21 days. Results: The median age was 51 (range: 27-68). Some 17 patients had multimetastatic disease on the inital diagnosis. Histopathological diagnoses were well-moderate differentiated adenocarcinoma (51.7%), undifferentiated carcinoma (27.6%), squamous cell cancer (13.8%), mucoepidermoid carcinoma (3.4%) and neuroendocrine differentiated carcinoma (3.4%). Median number of cycles was 3 (range: 1-6). Objective response rate was 37.9% and clinical benefit was 58.6%. Median progression free survival (PFS) and overall survival (OS) were 6 months (range: 4.3-7.7 months) and 16 months (range: 8.1-30.9 months), respectively. Fourteen patients (60.8%) were treated in a second line setting. There was no treatment related death. Most common toxicities were nausia-vomiting (44.6%) and fatigue (34.7%), serious cases (grade 3/4) suffering nausia-vomiting (10.3%), neutropenia (13.8%) and febrile neutropenia (n=1). Conclusion: The combination of cisplatin and docetaxel is an effective regimen for selected patients with CUP.