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开腹手术中超声引导下不可逆电穿孔联合化疗治疗局部进展期胰腺癌64例临床报告

Combining intraoperative ultrasound-guided irreversible electroporation with chemotherapy for treating locally advanced pancreatic cancer: a clinical report of 64 cases

摘要目的:探讨开腹手术中超声引导下不可逆电穿孔(IRE)联合化疗治疗局部进展期胰腺癌(LAPC)的安全性和效果。方法:回顾性收集2015年8月至2019年3月在中山大学附属肿瘤医院接受IRE联合化疗的64例LAPC患者的临床资料,男性30例,女性34例,中位年龄58.5岁(范围:34~87岁)。肿瘤位于胰头30例、胰体尾34例。肿瘤平均最大径6.1 cm(≤4.0 cm 35例、>4.0 cm 29例)。开腹手术中超声引导下进行IRE消融,根据肿瘤大小选择2~6根消融电极针,针距2 cm且相互平行,在横结肠系膜下方由足侧向头侧进针,使消融范围完全覆盖肿瘤。按治疗顺序将前15例和后49例分别定义为初期治疗组和中后期治疗组。符合正态分布的计量资料的比较采用 t检验;计数资料的比较采用χ 2检验。Kaplan-Meier法计算患者的总体生存(OS)和肿瘤无进展生存(PFS),Log-rank检验比较各临床病理学指标对生存率的影响。 结果:全组住院时间为(8.9±2.7)d(范围:5~20 d)。并发症发生率为20.3%(13/64),其中B级胰瘘、切口感染、上消化道大出血分别有7、4、2例。初期治疗组并发症发生率为10/15,2例死亡;中后期治疗组并发症发生率6.1%(3/49),无死亡病例。两组并发症发生率的差异有统计学意义(χ 2=26.01, P<0.01)。术后1个月腹痛减轻者占95.3%(61/64)( t=-28.55, P<0.01)。60例患者获得随访,随访率为93.8%,中位随访时间为29.3个月(范围:13.5~55.7个月)。全组OS时间为24.6个月(95 %CI:22.0~27.3个月),PFS时间为12.0个月(95 %CI:8.8~15.2个月)。 结论:开腹手术中超声引导下IRE联合化疗治疗LAPC的安全性和效果较好,但其治疗价值有待前瞻性多中心随机对照临床试验进一步证实。

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abstractsObjective:To examine the safety and clinical efficacy of ultrasound-guided irreversible electroporation (IRE) using the open surgery approach, after induction chemotherapy, in the treatment of locally advanced pancreatic cancer (LAPC) .Methods:The data of 64 LAPC patients who underwent ultrasound-guided IRE using the open surgery approach after induction chemotherapy at Department of Pancreatobiliary Surgery, Sun Yat-sen University Cancer Center from August 2015 to March 2019 were retrospectively analyzed. The study comprised of 30 males and 34 females, with median age of 58.5 years old (range: 34 to 87 years old) , were included in this study.The tumor was located in the pancreatic head and body/tail in 30 and 34 patients, respectively.The largest recorded tumor size was 6.1 cm (≤4.0 cm: n=35; >4.0 cm: n=29) .To create an electric field around the tumor, Two to six probes were parallelly inserted into each patient′s tumor, based on the size of the tumor, at a distance of 2 cm apart through the transverse mesocolon in a caudal-to-cranial direction.According to the numerical sequence of patients undergoing ultrasound-guided IRE, the first 15 cases and following 49 patients were categorized as the primary and secondary treatment group, respectively.T text or χ 2 test was analyzed to the data between two groups.The study endpoints were overall survival (OS) and progression free survival (PFS) , which were investigated using Kaplan-Meier method, and their differences were compared using log-rank test. Results:The overall length of hospital stay was (8.9±2.7) days (range: 5 to 20 days) . Four patients were lost to follow-up.The study follow-up rate was 93.8%, with a median follow-up time of 29.3 months (range: 13.5 to 55.7 months) .The median OS and PFS of the entire cohort was 24.6 months (95 % CI: 22.0 to 27.3 months) and 12.0 months (95 %CI: 8.8 to 15.2 months) , respectively.One month after IRE, abdominal pain was significantly relieved in 95.3% of the patients ( t=-28.55, P<0.01) .The rate of complications in the entire cohort was 20.3% and all were classified as grade B.Of them, pancreatic fistula, incisional infection, and upper gastrointestinal hemorrhage were observed in 7, 4, and 2 cases, respectively.The rate of complications for patients in the primary and secondary treatment groups were significantly different (10/15 vs. 6.1%) , respectively (χ 2=26.01, P<0.01) .Further, two deaths were observed after IRE in the primary treatment group, while none was observed in the secondary treatment group. Conclusions:Ultrasound-guided IRE using the open surgery approach after induction chemotherapy is found to be safe and effective in treating patients with LAPC.However, these findings should be validated in prospective randomized trials before wide clinical application.

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DOI 10.3760/cma.j.cn112139-20200331-00270
发布时间 2025-03-04
基金项目
国家重点研发计划 国家自然科学基金 State Key Research and Development of China National Natural Science Foundation of China
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中华外科杂志

中华外科杂志

2020年58卷10期

787-792页

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