![]() Assessment of laparoscopic stomach preserving surgery with sentinel basin dissection versus standard gastrectomy with lymphadenectomy in early gastric cancer–A multicenter randomized phase III clinical trial (SENORITA trial) protocol. In recent years there has been a rapid increase in the detection of early stage gastric cancer in Korea and Japan, and the number of long- term survivors has markedly increased accordingly [2. In an effort to preserve the patient’s post- treatment QOL, minimally invasive procedures, such as laparoscopic surgery, have gained widespread popularity in gastric cancer treatment [2. Endoscopic resection, which is regarded as less invasive for preserving physiological gastric function, is one such alternative option for carefully selected patients with EGC and very low risk of lymph node metastasis. However, the range of its application is limited, and an extension of the eligible criteria is still debated because of the possibility of neglecting a metastatic lymph node. Accurate prediction of lymph node metastasis is mandatory in order to reduce the extent of surgery, without hampering oncologic safety in EGC patients. Presently, however, no modality is capable of making a definite diagnosis of nodal metastasis before surgical resection. Although the technology used for preoperative evaluation, including endoscopy, abdominal CT, and endoscopic ultrasonography has markedly developed so far, it still has limited accuracy for nodal staging in gastric cancer patients. In recent decades, significant effort has also been undertaken to improve biomedical imaging technology for noninvasive detection of microscopic metastases in lymph nodes; this involves multiple imaging modalities including ultrasonography, magnetic resonance images, and positron emission tomography, as well as, novel technologies such as nanotechnology and photoacoustic imaging [2. However, these promising techniques still require further investigation to have an impact in clinical practice. Alternatively, the SN concept, despite some level of invasiveness, is expected to facilitate the avoidance of extensive lymph node dissection, and subsequently to preserve physiologic function in relevant patients with metastatic node- free gastric cancer, as long as it is proven to be feasible and safe. Many investigators have evaluated the applicability of SN navigation surgery in gastric cancer. Intervention. The intervention involved a two-step checklist-implementation program. After collecting baseline data, each local investigator was given information. NHS Resolution has appointed two senior clinical advisors to the early notification scheme. Since April1 all trusts are now required to report all maternity incidents. The results are inconsistent across studies in terms of the accuracy and sensitivity of SN biopsy for detecting nodal metastasis in gastric cancer; however, most of these studies were conducted with a small population at a single center [2. Nonetheless, a series of recent studies have reported the feasibility of SN navigation surgery in EGC patients [1. Therefore, we herein propose a multicenter randomized clinical trial primarily to elucidate the oncologic safety of SBD with stomach- preserving surgery compared to the standard laparoscopic gastrectomy with lymphadenectomy. The most challenging aspect of designing a randomized controlled trial involving surgical procedures is that it is difficult to blind the surgeons and patients as to the intervention. Moreover, the ethical concerns with regards to the blinding of patients must also be considered. Therefore, the primary end- point should be a purely objective variable, such as DFS, as in this clinical trial, to minimize potential bias caused by non- blinding. Secondly, the surgical procedure per se is inevitably operator- dependent and can vary among the participating surgeons. As such, it would be challenging to extrapolate the results of a single- institution trial to other centers. A multicenter trial is also associated with biases, such as differences in operative skill and experience, as well as, in perioperative care among participants. The tendency toward such bias would certainly become stronger when the procedure is more complicated and involves investigators from different departments. Therefore, we obtained in- depth advice from experts in the field before the development of this study protocol. We also conducted a quality control study prior to the initiation of this phase III trial to qualify participating institutions [1. A detailed step- by- step checklist was provided to investigators participating in the previous quality control study. It was recommended that the checklist be completed for at least 1. Repetitive discussion during this quality control study allowed participating investigators to achieve consensus and standardize the specific procedures outlined in this subsequent phase III SENORITA trial protocol. In conclusion, amid the consistent effort to adopt the SN concept in gastric cancer, the proposed SENORITA trial represents a multicenter randomized controlled trial to elucidate the oncologic safety, as well as, postoperative QOL following laparoscopic SBD with stomach- preserving surgery compared to the standard laparoscopic gastrectomy with lymph node dissection in EGC patients. We believe that this trial would significantly contribute to the evolution of surgical practice in EGC in the future. Methods/Design. This trial is an investigator-initiated, open-label, multicenter randomized controlled phase III trial with a non-inferiority design. Autism spectrum disorders are not rare; many primary care pediatricians care for several children with autism spectrum disorders. Pediatricians play an important role. Clinical Trial Site Initiation Visit Checklist For Vacation
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November 2017
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