作者: Robert C.G. Martin , Kelli McFarland , Susan Ellis , Vic Velanovich
DOI: 10.1016/J.JAMCOLLSURG.2012.05.021
关键词: Surgery 、 Clinical trial 、 Irreversible electroporation 、 Pancreatitis 、 Prospective cohort study 、 Pancreatectomy 、 Medicine 、 Investigational device exemption 、 Adenocarcinoma 、 Pancreas
摘要: Background Locally advanced pancreatic cancer patients have limited options for disease control. Local ablation technologies based on thermal damage been used but are associated with major complications in this region of the pancreas. Irreversible electroporation (IRE) is a nonthermal technology that we shown safe near vital vascular and ductal structures. The aim study was to evaluate safety efficacy IRE as therapy treatment locally cancer. Study Design We performed prospective multi-institutional pilot evaluation undergoing from December 2009 March 2011. These were evaluated 90-day morbidity, mortality, local Results Twenty-seven (13 women 14 men) underwent IRE, median age 61 years (range 45 80 years). Eight margin accentuation combination left-sided resection (n = 4) or head 4). Nineteen had situ IRE. All successful intraoperative imaging confirming effective delivery therapy. 27 demonstrated nonclinically relevant elevation their amylase lipase, which peaked at 48 hours returned normal 72 hour postprocedure. There has one mortality. No patient evidence clinical pancreatitis fistula formation. After all completed follow-up, there 100% success. Conclusions tumors feasible primary unresectable, disease. Confirming these early results must occur planned phase II investigational device exemption (IDE) be initiated 2012.