RESUMEN
Background/Aims@#The aim of this study was to evaluate the safety and efficacy of partially covered self-expandable metallic stents (PCSEMS) in patients undergoing neoadjuvant chemo (radio) therapy (NAC) for pancreatic cancer (PC). @*Methods@#This was a prospective multicenter study to evaluate the safety and efficacy of PCSEMS in patients receiving NAC for resectable and borderline resectable PC. The primary endpoint was the rate of recurrent biliary obstruction (RBO). @*Results@#Twenty-six patients with PC (three with resectable PC and 23 with borderline resectable PC) who underwent NAC at seven Japanese centers were included in the analysis. Both the technical and functional success rates of PCSEMS placement were 100%. Early stent-related complications were observed in three patients (11.5%): mild pancreatitis (n=2) and mild liver abscess (n=1). The median time to surgery or palliation was 4.0 months. Surgical resection was eventually performed in 73.1% of patients, and stent removal during surgery was successful in all patients. RBO was observed in nine patients (34.6%): seven with stent occlusion, one with kinking and one with migration. The RBO rates in resected cases and nonresected cases were 36.8% and 28.6%, respectively. @*Conclusions@#Biliary drainage by PCSEMS was safe and feasible in patients undergoing NAC for resectable and borderline resectable PC.
RESUMEN
In Japan, large scale health databases were constructed in a few years, such as National health insurance claim and health checkup database(NDB) and Japanese Sentinel project. But the there are some legal issues for making adequate balance between privacy and public benefit by using such databases. NDB is carried based on the act for elderly person's health care but in this act, nothing is mentioned for using this database for general public benefit. Therefore researchers who use this database are forced to pay much concern about anonimization and information security that may disturb the research work itself. Japanese Sentinel project is a National project to detecting drug adverse reaction using large scale distributed clinical databases of large hospitals. Although patients give the future consent for general such purpose for public good, it is still under discussion using insufficiently anonymized data. Generally speaking, researchers of study for public benefit will not infringe patient's privacy, but vague and complex requirements of legislation about personal data protection may disturb the researches. Medical science does not progress without using clinical information, therefore the adequate legislation that is simple and clear for both researchers and patient is strongly required. In Japan, fortunately, the specific act for balancing privacy and public benefit is planned to lay before Diet, but is still under discussion. The author recommended the researchers including the field of pharmacoepidemiology should pay attention to, participate in the discussion of, and make suggestion to this act. (Jpn J Pharmacoepidemiol 2012; 17(2): 101-107)