Background 

No study has compared EUS-guided radiofrequency ablation (EUS-RFA) plus systemic chemotherapy (CMT) with CMT alone for unresectable pancreatic ductal adenocarcinoma.

Methods 

This study compared the results of treatment in patients receiving EUS-RFA plus concomitant CMT (group A; n = 14) with those receiving CMT (group B; n = 14) as a pilot study.

Results 

From July 2017 to August 2018, 4 and 2 patients from groups A and B, respectively, withdrew from the study because of progression of the disease. In total, 10 and 12 patients from groups A and B, respectively, completed the study. All 30 EUS-RFA procedures were successful. Mean maximal tumor diameter before treatment of group A (n = 10) versus B (n = 12) was 62.2 ± 21.0 versus 50.5 ± 22.0 mm, respectively (P = not significant). After treatment, no statistically significant difference in mean maximal tumor diameter was found between both groups. However, in group B, mean maximal tumor diameter was significantly increased from 50.5 ± 22.0 to 56.3 ± 18.7 mm, respectively (P = 0.017). Tumor necrosis occurred in group A versus B at 10 of 10 (100%) versus 6 of 12 (50%) patients, respectively (P = 0.014). After treatment, group A patients could reduce the mean narcotic pain drug dosage at 26.5 mg of morphine equivalent per day (from 63.6 to 37.1 mg, P = 0.022), whereas group B patients could not reduce the dosage of pain-controlled medication. No statistically significant difference in 6-month mortality rate was found. In group A, 1 procedure-related nonsevere adverse event (n = 1 of 30 [3.3%]) occurred in 1 patient (n = 1 of 14 [7.1%]).

Conclusions 

In this study, the mean tumor diameter of group B was significantly increased after the treatment. Group A had a significantly higher rate of necrosis of tumor and required less narcotic.

中文翻译：

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EUS 引导下射频消融联合化疗与单独化疗治疗胰腺癌 (ERAP)：一项观察性开放标签试点研究

背景 

目前还没有研究比较 EUS 引导射频消融 (EUS-RFA) 联合全身化疗 (CMT) 与单独 CMT 治疗不可切除的胰腺导管腺癌的情况。

方法 

本研究将接受 EUS-RFA 加伴随 CMT 的患者（A 组； n = 14）的治疗结果与接受 CMT 的患者（B 组；n = 14）的治疗结果进行比较，作为一项试点研究。

结果 

2017年7月至2018年8月，A组和B组分别有4名和2名患者因病情进展退出研究。A 组和 B 组分别有 10 名和 12 名患者完成了研究。所有 30 例 EUS-RFA 手术均成功。A 组 ( n = 10)与B 组 ( n = 12)治疗前的平均最大肿瘤直径分别为 62.2 ± 21.0和50.5 ± 22.0 mm（P = 不显着）。治疗后，两组之间的平均最大肿瘤直径没有统计学上的显着差异。然而，在 B 组中，平均最大肿瘤直径分别从 50.5 ± 22.0 显着增加至 56.3 ± 18.7 mm（P = 0.017）。A 组和B 组分别有 10 名患者中的 10 名（100%）和12 名患者中的 6 名（50%）发生肿瘤坏死（ P = 0.014）。治疗后，A组患者可将平均麻醉止痛药物剂量减少至每天26.5 mg吗啡当量（从63.6 mg减少至37.1 mg，P = 0.022），而B组患者不能减少镇痛药物剂量。6个月死亡率没有发现统计学上的显着差异。在 A 组中，1 名患者（ n = 14 例中的 1 例 [7.1%]）发生 1 例与手术相关的非严重不良事件（n = 30 例中的​​ 1 例 [3.3%]）。

结论 

在本研究中，B组治疗后平均肿瘤直径显着增加。A组肿瘤坏死率明显较高，且需要较少的麻醉剂。