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不可逆电穿孔治疗局部晚期胰腺癌——丹麦单中心安全性和可行性研究

Treatment of locally advanced pancreatic cancer with irreversible electroporation - a Danish single center study of safety and feasibility.

作者信息

Flak Rasmus Virenfeldt, Stender Mogens Tornby, Jensen Thomas Mandøe, Andersen Kasper Lenni, Henriksen Stine Dam, Mortensen Peter Brøndum, Sall Mogens, Thorlacius-Ussing Ole

机构信息

a Department of Gastrointestinal Surgery , Aalborg University Hospital , Aalborg , Denmark.

b Department of Radiology , Aalborg University Hospital , Aalborg , Denmark.

出版信息

Scand J Gastroenterol. 2019 Feb;54(2):252-258. doi: 10.1080/00365521.2019.1575465. Epub 2019 Mar 24.

DOI:10.1080/00365521.2019.1575465
PMID:30907286
Abstract

OBJECTIVES

Irreversible electroporation (IRE) is a novel non-thermal ablative technique applied in the treatment of unresectable locally advanced pancreatic cancer (LAPC). This paper reports on the initial experience with IRE of unresectable LAPC in our institution.

METHODS

From October 2013 to March 2018, patients with unresectable LAPC referred for IRE at the Department of Gastrointestinal Surgery, Aalborg University Hospital, were considered for inclusion in the study. Ninety-day morbidity, 30-day mortality, pain score, length of hospital stay (LOS) and overall survival (OS) were recorded.

RESULTS

We included 33 patients receiving 40 IRE ablations in total. The median visual analogue scale (VAS)-score was four (range 0-10) two hours after IRE, and one (range 0-8) eight hours after IRE. The median LOS was one day (range 1-13 days). Post-procedural complications occurred in 21 of 40 ablations (53%), of which eight (20%) were major (Clavien-Dindo grade III or more). A proportion of the observed complications might be attributed to disease progression and not IRE per se. Although not statistically significant, we observed increased severity of complications in tumors above 3.5 cm. The 30-day mortality was 5% (2/40). The median OS was 10.7 months (range 0.6-53.8 months) from the initial IRE procedure, and 18.5 months (range 4.9-65.8 months) from time of diagnosis.

CONCLUSIONS

In our institution, IRE seems as a feasible consolidative treatment of unresectable LAPC with an acceptable safety profile. The oncological outcome of IRE in patients with unresectable LAPC is to be further evaluated in a planned phase 2 clinical trial (CHEMOFIRE-2).

摘要

目的

不可逆电穿孔(IRE)是一种应用于治疗不可切除的局部晚期胰腺癌(LAPC)的新型非热消融技术。本文报告了我院对不可切除LAPC进行IRE治疗的初步经验。

方法

2013年10月至2018年3月,奥尔堡大学医院胃肠外科转诊接受IRE治疗的不可切除LAPC患者被纳入本研究。记录90天发病率、30天死亡率、疼痛评分、住院时间(LOS)和总生存期(OS)。

结果

我们共纳入33例患者,总共接受了40次IRE消融治疗。IRE后两小时,视觉模拟量表(VAS)评分中位数为4分(范围0 - 10分),IRE后八小时为1分(范围0 - 8分)。LOS中位数为1天(范围1 - 13天)。40次消融中有21次(53%)发生术后并发症,其中8次(20%)为严重并发症(Clavien-Dindo分级III级或更高)。部分观察到的并发症可能归因于疾病进展而非IRE本身。尽管无统计学意义,但我们观察到肿瘤直径大于3.5 cm时并发症严重程度增加。30天死亡率为5%(2/40)。从首次IRE手术起,OS中位数为10.7个月(范围0.6 - 53.8个月),从诊断时起为18.5个月(范围4.9 - 65.8个月)。

结论

在我院,IRE似乎是一种治疗不可切除LAPC的可行巩固治疗方法,安全性可接受。不可切除LAPC患者IRE的肿瘤学结局将在计划中的2期临床试验(CHEMOFIRE-2)中进一步评估。

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