Nihon Geka Gakkai Zasshi
· 2016 Jan · PMID 27078900
Clinical trials/research are conducted to examine the clinical questions of practicing physicians. It is important to design trials appropriately in advance, taking their feasibility into account. A randomized, controlle...Clinical trials/research are conducted to examine the clinical questions of practicing physicians. It is important to design trials appropriately in advance, taking their feasibility into account. A randomized, controlled trial is the ultimate design for treatment comparisons at the final confirmatory stage. However, randomized trials do not necessarily provide all answers to clinical questions. This article summarizes fundamental points of clinical trial design and the important role of randomization and contrasts superiority and noninferiority trials. In addition, it focuses on propensity score matching, a useful method to compare two treatment arms, especially in the context where randomization is infeasible. The propensity score-matching method is increasingly used in surgical clinical research.
Nihon Geka Gakkai Zasshi
· 2016 Jan · PMID 27078899
Clinical trials are conducted based on the development of surgical technology and are designed to answer specific research questions. In planning clinical trials population, intervention, comparison, and outcome are impo...Clinical trials are conducted based on the development of surgical technology and are designed to answer specific research questions. In planning clinical trials population, intervention, comparison, and outcome are important elements. Sample size calculation is also central to the design of clinical trials, especially randomized, controlled ones. This article outlines study phases, four important elements of design, and sample size calculation.
Nihon Geka Gakkai Zasshi
· 2016 Jan · PMID 27078898
Remarkable progress has been made in surgical techniques and instruments, and the significance of clinical studies as a method to assess them is increasing. Recently, the long-term results of the randomized, controlled t...Remarkable progress has been made in surgical techniques and instruments, and the significance of clinical studies as a method to assess them is increasing. Recently, the long-term results of the randomized, controlled trial of laparoscopic and open surgery for colon cancer JCOG0404 have been reported. Although the survival results were good in both the laparoscopic and open groups, the noninferiority of laparoscopic surgery was not demonstrated. Noninferiority comparisons are not easy to understand. This article considers nohinferiority tests and their difficulty from a clinician's viewpoint In addition to problems with noninferiority tests, clinical trials in the surgical field involve many considerations, such as assessments of surgical quality, issues in double blinding, patients' unwillingness to participate, the occurrence of learning curves, etc. Considering the uniqueness of surgical clinical studies, the author comments on the necessity of randomized clinical trials, importance of prospective and retrospective observational studies, and significance of noninferiority trials and large studies. For the future development of surgery, clinical studies are one of the most important areas of focus, and a thorough understanding of clinical studies and driving studies is necessary.
Nihon Geka Gakkai Zasshi
· 2015 Nov · PMID 26845891
Because the number of heart failure patients increases every year, improved prevention and treatment for damaged hearts are needed. Many investigators have explored new approaches to improve cardiac function, including c...Because the number of heart failure patients increases every year, improved prevention and treatment for damaged hearts are needed. Many investigators have explored new approaches to improve cardiac function, including cell transplantation and gene therapy. MicroRNAs comprise a novel class of endogenous, small, noncoding RNAs that negatively regulate gene expression via degradation or translational inhibition of their target mRNAs. Recent studies have described microRNAs as fine-tuners of gene expression. New therapeutic strategies for heart failure using microRNAs such as cardiac reprogramming therapy by overexpression of microRNAs in murine infarcted hearts and prevention of cardiac remodeling using antagomirs in hypertensive rat models are promising technologies for future clinical application. Moreover, microRNAs could possibly function as biomarkers of heart failure. MicroRNA-145 is a specific mediator of the regulation of the vascular smooth muscle cell phenotype. We reported that transduction of microRNA-145 into vein grafts may be a novel option for preventing vein graft disease after surgical revascularization, since its transduction reduced neointimal thickness in the rabbit model of vein graft disease. Although several issues regarding microRNAs need to be overcome, their therapeutic potential holds considerable promise, and they will hopefully be combined with surgical strategies in the near future.
Yamamoto H, Toyooka S, Maki Y
… +2 more, Soh J, Miyoshi S
Nihon Geka Gakkai Zasshi
· 2015 Nov · PMID 26845890
Recent advances in cancer research have revealed that noncoding RNAs such as microRNAs and long noncoding (lnc) RNAs play important roles in various cancers including lung cancer. Noncoding RNAs have the potential to bec...Recent advances in cancer research have revealed that noncoding RNAs such as microRNAs and long noncoding (lnc) RNAs play important roles in various cancers including lung cancer. Noncoding RNAs have the potential to become new biomarkers of cancer in the clinical setting, that is, they may be useful for the early detection, prognostic prediction, and prediction of sensitivity to chemotherapy and radiotherapy. It is also expected that noncoding RNAs can become new therapeutic targets. Aberrant expression of several microRNAs and lncRNAs has been reported in lung cancer, and there is a possibility of the identification of new therapeutic targets in the near future. To contribute to improved outcomes of lung cancer treatment, it is necessary to detect patients who are candidates for surgery in an earlier stage to increase the number undergoing radical surgery and to select those who are at high risk of recurrence postoperatively to increase opportunities for treatment to prevent it. Thus, it is important to discover new biomarkers for lung cancer. Surgeons can take the initiative in research, as they have easy access to specimens from lung cancer patients.
Nihon Geka Gakkai Zasshi
· 2015 Nov · PMID 26845889
Noncoding RNA (ncRNA) has a crucial role in the molecular mechanisms of malignant features of breast cancer. This review outlines the biological and clinical significance of well-investigated microRNAs including let-7, m...Noncoding RNA (ncRNA) has a crucial role in the molecular mechanisms of malignant features of breast cancer. This review outlines the biological and clinical significance of well-investigated microRNAs including let-7, miR-21, miR-200, miR-15/16, miR-155, and miR-221/222, and long ncRNAs such as H19, LSINCT5, HOTAIR, and GAS5. The biological roles of microRNAs secreted in the exosome are also described. Combined analysis of mRNA and ncRNA will help to develop the field of genetic diagnosis of breast cancer.