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Objective:To analyze the current situation of Investigator-Initiated Trials in medical and health institutions in Shandong Province, the problems in the process of conducting clinical research, and put forward proposals for the establishment of a clinical research management system with effective supervision, sound systems and supporting services, taking into account the progress of the projects since the pilot work was carried out.Methods:A questionnaire was created, an online survey was conducted, a database was set up, a status analysis was conducted and a post-launch analysis of the progress of the pilot was carried out using the National Medical Research Registry Information System, culminating in recommendations using the literature summary method and empirical analysis.Results:Statistical analysis of the questionnaire found that 29.39% of the institutions have a dedicated clinical research management department, and 75.97% of the institutions have a management approach. 25.52%, 40.30%, and 43.07% of institutions established biobanks, clinical research centers, and follow-up centers. There was a statistically significant difference in the establishment of clinical research centers, biobanks, and follow-up centers in secondary and tertiary medical institutions ( P<0.05). The number of general clinical research projects filed, the number of submissions and the number of ethics committees filed in the filing system have all increased significantly after the pilot work, with growth percentages of 126%, 141% and 62% respectively. Conclusions:Shandong Province clinical research pilot work has begun to bear fruit, the current clinical research project still exists in the lack of special funding support, perfect service platform and system support and training system to be improved and other issues.
RESUMO
Objective To discuss the clinical application of individualized strategy of endoscopic retrograde cholangiopancreatography (ERCP) in the treatment of bile duct stenosis after liver transplantation (LT).Methods Fifty-two patients,including 40 men and 12 women,aged 54.3 ± 9.1 years old,who suffered from bile duct stenosis and accepted 88 times of ERCP from June 2014 to May 2016 in our department were investigated.The procedures,clinical features and biochemical criteria were analyzed retrospectively.Results According to the treating occasions and clinical symptoms,single plastic stent,dilatation combined with single plastic stent,and dilatation combined with multiple plastic stents were chosen to use.ERCP in 8 patients out of 52 patients failed technically,and the therapeutic efficacy was 82.7％.The treatment duration was 8.2 ± 2.9 months.The recurrence rate was 4.7％ (2 cases) during the follow-up period.The most common complications were postERCP pancreatitis (2.3％) and cholangitis (3.4％),which would be cured by conservative treatment in most cases.Conclusion ERCP,as an effective and safe method,could be used as the first choice or bridge treatment for bile duct stricture after LT.We recommend individualization strategy,including step by step mode and different combinations of PTC or endoscopic procedures,in order to improve clinical efficacy of all kinds of stricture.