Search

We conducted a prospective multicenter phase II trial of patients with borderline resectable pancreatic carcinoma to investigate the efficacy of neoadjuvant nab-paclitaxel plus gemcitabine thera py on ov erall survival (OS). The clinical trial primarily evaluated OS time from the first day of protocol therapy as a primary endpoint. The secondary endpoints were recurrence-free survival from the first day of protocol therapy, safety of the protocol therapy (adverse effect), mor-bidity based on the Clavien Dindo classification of more than III, response rate, preoperative/postoperative tumor marker (CA 19-9, CEA), rate of normalization, reduction rate of the maximum standardized uptake value on positron emission tomography-computed tomography (limited to institutions where positron emission tomography-computed tomography was available), chemotherapeutic effect grade based on Evans' classification, resection rate, R0 resection rate, surgical data (operative time, blood loss, transfusion, postoperative hospital day), overall morbidity rates (reoperation, rate of readmission, mortality), patient rate in postoperative adjuvant therapy (entry rate, completion rate), dose intensity, quality of life regarding fatigue and malaise assessed by the questionnaire of FACIT-F (Japanese version), and peripheral sensory neuropathy assessed by the questionnaire of the FACT/GOG-NTX subscale (version 4; Japanese version). Sixty patients were included in the study, and 18 leading Japanese institutions and hospitals (all high-volume centers in pancreatic surgery) participated in this trial. [ABSTRACT FROM AUTHOR]

Introduction: In clinical research, ethical review is required prior to conducting the research. A surgical procedure is a complex intervention with properties that make it more difficult to evaluate rigorously and monitor than drug treatments. This study aimed to clarify the current status and issues in the ethical review and monitoring of surgical research., Methods: We developed a self-administered questionnaire on surgical ethical review. The questionnaire was distributed to university hospitals in Japan and collected from November 2018 to February 2019. The distributed questionnaire consisted of the reviewed items, items with difficulties, and important items on ethical review. Fisher's exact test or the chi-square test was used for analysis., Results: The questionnaires from 39 medical university hospitals were completed with appropriate answers to all items. "Technical review" was conducted at a significantly lower proportion (n = 30/39, 76.9%, p = 0.002). "Evaluation of the progress and results" was also (n = 22/39, 56.4%, p < 0.001). University hospitals in which "technical aspects and ethical review" was regarded the most important and difficult were higher (n = 24/39, 61.5%; n = 26/39, 66.7%, respectively). Respondents considered not only items written in the study protocol but also those on monitoring or oversight of surgical research as difficult., Conclusions: Our findings suggest that it is necessary to improve the ethical review system and provide supports to conduct an appropriate review for surgical research, e.g., technical aspect review or study progress/result evaluation., Competing Interests: None, (Copyright © Japan Medical Association.)