The Safety and Efficacy of an Alcohol-Free Pancreatic Cyst Ablation Protocol
The Safety and Efficacy of an Alcohol-Free Pancreatic Cyst Ablation Protocol
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DOI：
10.1053/j.gastro.2017.08.009
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发表时间：
2017-11-01
期刊：
影响因子：
29.4
通讯作者：
Dye, Charles E.
中科院分区：
文献类型：
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作者：
Moyer, Matthew T.;Sharzehi, Setareh;Dye, Charles E.
背景与目的：内镜超声引导下无水乙醇灌注化疗消融联合紫杉醇灌注治疗胰腺黏液囊肿是一种有效的治疗方法。然而，3% - 10%的患者会出现并发症，可能与乙醇的炎症作用有关。我们的目的是确定酒精是否是有效的胰腺囊肿消融术所必需的，如果从消融过程中去除酒精将改善并发症发生率，以及与先前使用酒精然后单独使用紫杉醇的试验结果相比，多药化疗鸡尾酒是否可以增加囊肿完全消退的速度。方法：在2011年11月至2016年12月期间，我们对39例粘液型胰腺囊肿患者进行了一项单中心、前瞻性、双盲试验。患者被随机分配到两组中的一组，分别接受EUS引导下80%乙醇（对照组）或生理盐水（无酒精组）胰腺囊肿灌洗。两组的囊肿均输注紫杉醇和吉西他滨的混合物。主要结局是术后12个月的完全消融率以及术后30天内严重和轻微不良事件的发生率。研究结果：在12个月时，67%接受无酒精EUS引导囊肿化学消融术的患者完全消融囊肿，而对照组患者为61%。对照组有6%的患者发生严重不良事件，而无酒精组无患者发生严重不良事件。对照组中22%的患者发生轻微不良事件，无酒精组中无患者发生。完全消融的总体率为64%。结论：在这项前瞻性、随机、对照试验中，我们发现有效的EUS引导下胰腺囊肿消融术不需要酒精，当消融过程中去除酒精时，相关不良事件显著减少。与目前的酒精灌洗标准相比，多药化疗消融混合物似乎没有显着提高完全消融率，然后单独使用紫杉醇。
BACKGROUND & AIMS: Endoscopic ultrasound (EUS) - guided chemoablation with ethanol lavage followed by infusion of paclitaxel is effective for the treatment of mucinous pancreatic cysts. However, complications arise in 3% - 10% of patients, presumably linked to the inflammatory effects of ethanol. We aimed to determine whether alcohol is required for effective pancreatic cyst ablation, if removing alcohol from the ablation process would improve complication rates, and whether a multi-agent chemotherapeutic cocktail could increase the rate of complete cyst resolution compared with findings reported from previous trials using alcohol followed by paclitaxel alone. METHODS: Between November 2011 and December 2016, we conducted a single-center, prospective, double-blind trial of 39 patients with mucinous-type pancreatic cysts. Patients were randomly assigned to 1 of 2 groups that underwent EUS-guided pancreatic cyst lavage with either 80% ethanol (control) or normal saline (alcohol-free group). Cysts in both groups were then infused with an admixture of paclitaxel and gemcitabine. Primary outcomes were the rates of complete ablation 12 months after the procedure, and rates of serious and minor adverse events within 30 days of the procedure. RESULTS: At 12 months, 67% of patients who underwent alcohol-free EUS-guided cyst chemoablation had complete ablation of cysts compared with 61% of patients in the control group. Serious adverse events occurred in 6% of patients in the control group vs none of the patients in the alcohol-free group. Minor adverse events occurred in 22% of patients in the control group and none of the patients in the alcohol-free group. The overall rate of complete ablation was 64%. CONCLUSIONS: In this prospective, randomized, controlled trial, we found that alcohol is not required for effective EUS-guided pancreatic cyst ablation, and when alcohol is removed from the ablation process, there is a significant reduction in associated adverse events. A multi-agent chemotherapeutic ablation admixture did not appear to significantly improve rates of complete ablation compared with the current standard of alcohol lavage followed by paclitaxel alone.