Kluger Michael D, Epelboym Irene, Schrope Beth A, Mahendraraj Krishnaraj, Hecht Elizabeth M, Susman Jonathan, Weintraub Joshua L, Chabot John A
Division of Gastrointestinal & Endocrine Surgery, Department of Surgery, New York-Presbyterian Hospital, Columbia University, College of Physicians and Surgeons, New York, NY, USA.
Division of Abdominal Imaging, Department of Radiology, Columbia University, College of Physicians and Surgeons, New York, NY, USA.
Ann Surg Oncol. 2016 May;23(5):1736-43. doi: 10.1245/s10434-015-5034-x. Epub 2015 Dec 29.
Irreversible electroporation (IRE) for treatment of locally advanced pancreatic tumors is garnering increasing attention. This study was conducted to determine perioperative morbidity and mortality for locally advanced pancreatic cancer.
Prospective data of 50 consecutive patients receiving IRE for T4 lesions at a single tertiary center were analyzed. The primary end point was Clavien-Dindo complications at 90 days, and the secondary outcomes were survival and recurrence.
A total of 50 patients underwent 53 IRE procedures for primary treatment (n = 29) or margin extension (n = 24), and 47 patients had adenocarcinoma. Six patients died within 90 days after the procedure (5 in the primary control group). Mortality occurred a median of 26 days (range, 8-42 days) after the procedure. Five patients in both the margin-extension and primary control groups experienced grade 3 or 4 morbidity (p = 0.739). The incidences of grades 3 to 5 complications did not differ significantly based on the adjustable parameters of IRE, tumor size, or primary treatment versus margin extension. After a median follow-up period of 8.69 months [interquartile range (IQR), 0.26-16.26 months], the median overall survival period for the primary control group was 7.71 months [95 % confidence interval (CI), 6.03-12.0 months) and was not reached in the margin-extension group (p = 0.01, log-rank).
At the authors' center, the mortality rate after IRE was higher than reported in other series, with the majority occurring in the primary control group. Major morbidity trended around upper gastrointestinal bleeding, visceral ulcerations/perforations, and portal vein thromboses. This favors further investigation of the safety and efficacy of IRE.
不可逆电穿孔（IRE）用于治疗局部晚期胰腺肿瘤正受到越来越多的关注。本研究旨在确定局部晚期胰腺癌的围手术期发病率和死亡率。
分析了在单个三级中心连续接受IRE治疗T4病变的50例患者的前瞻性数据。主要终点是90天时的Clavien-Dindo并发症，次要结局是生存率和复发率。
共有50例患者接受了53次IRE手术，用于初次治疗（n = 29）或切缘扩大（n = 24），47例患者为腺癌。6例患者在术后90天内死亡（初次治疗组5例）。死亡发生在术后中位26天（范围8 - 42天）。切缘扩大组和初次治疗组均有5例患者发生3级或4级并发症（p = 0.739）。基于IRE的可调参数、肿瘤大小或初次治疗与切缘扩大，3至5级并发症的发生率无显著差异。中位随访期为8.69个月[四分位间距（IQR），0.26 - 16.26个月]，初次治疗组的中位总生存期为7.71个月[95%置信区间（CI），6.03 - 12.0个月]，切缘扩大组未达到（p = 0.01，对数秩检验）。
在作者所在中心，IRE术后死亡率高于其他系列报道，多数发生在初次治疗组。主要并发症倾向于上消化道出血、内脏溃疡/穿孔和门静脉血栓形成。这有利于进一步研究IRE的安全性和有效性。
