不可逆电穿孔治疗局限性前列腺癌的有效性和安全性

The efficacy and safety of irreversible electroporation in the treatment of localized prostate cancer

目的探讨不可逆电穿孔在局限性前列腺癌局灶消融治疗中的疗效和安全性。方法去回顾性分析2019年8月至2023年9月上海交通大学医学院附属仁济医院、华中科技大学同济医学院附属同济医院、同济大学附属东方医院收治的128例局限性前列腺癌患者的临床资料。中位年龄68(62,75)岁。中位前列腺特异性抗原(PSA)8.64(5.83,12.57)ng/ml。Cleason评分6分57例,7分39例,>7分19例。肿瘤分期T。期4例,T2a期69例,T2b期27例,T2期28例。术前检查均未见淋巴结和远处脏器转移。所有患者术前均无尿潴留或尿失禁。所有患者均行不可逆电穿孔治疗。全麻,患者取截石位。经直肠置人超声探头,根据测量的前列腺病灶大小选择电极针型号和数量。以病灶为核心周围布针,每两根消融针间距为0.5~2.0cm。系统自动生成电压、电流、脉冲数等治疗参数,每组脉冲约5min。治疗结束后拔除电极针并用纱布按压1min,用生理盐水1:1稀释的无痛碘溶液冲洗尿道后留置导尿管。记录治疗效果和不良反应发生率。生化复发定义为PSA高于不可逆电穿孔治疗后最低值2ng/ml;影像学复发定义为MRI或超声造影检查发现异常病灶。结果本研究128例手术均顺利完成。116例完成术后6个月随访。中位PSA1.58(0.56,2.95)ng/ml,较术前降低82.22%(65.37%,93.33%)(P<0.01)。5例(4.31%)出现生化复发,MRI或超声造影检查阴性,其中1例接受根治性前列腺切除术,术后病理诊断为前列腺癌;余4例继续随访。98例行MRI或超声造影检查,6例(6.12%)出现影像学复发,其中2例接受根治性前列腺切除术,术后病理诊断为前列腺癌;余4例接受内分泌治疗。所有患者随访期间均未发生严重不良反应。8例(6.89%)出现Ⅱ级并发症,其中1例为导尿管留置时间延长,可能为术后前列腺水肿所致,术后2周拔管后排尿通畅;2例拔除导尿管后出现轻度尿失禁,每天使用尿垫2块,3d后恢复正常;5例术后1~2周出现尿路感染,抗炎治疗后好转。结论不可逆电穿孔治疗局限性前列腺癌在肿瘤控制、安全性和尿控功能保留方面均有良好的效果。

Objective To investigate the efficacy and safety of irreversible electroporation in focal ablation of localized prostate cancer.Methods Clinical data of 128 patients with localized prostate cancer treated with irreversible electroporation from August 2019 to September 2023 at Renji Hospital of Shanghai Jiaotong University School of Medicine,Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology,and Dongfang Hospital of Tongji University,were retrospectively analyzed.The median age was 68(62,75)years.The median PSA was 8.64(5.83,12.57)ng/ml.Gleason score was 6 in 57 cases,7 in 39 cases,and greater than 7 in 19 cases.There were 4 cases of Tie,69 cases of T2a,27 cases of T2h,and 28 cases of T2..No lymph node or distant metastasis was seen in preoperative examination.All patients had no preoperative urinary retention or urinary incontinence.Irreversible electroporation treatment was administered under general anesthesia with patients in the lithotomy position.A transrectal ultrasound probe was used to measure prostate lesion size,determining the type and number of electrode needles.Electrode needles were strategically positioned around the targeted lesion.The distance between each pair of needles used for ablation ranged from 0.5 to 2.0 cm.The system automatically generated treatment parameters,including voltage,current,and the number of pulses,with each pulse cycle lasting approximately 5 minutes.After treatment,the needles were removed,gauze was applied for 1 minute.The urethra was then irrigated with a painless iodine solution diluted 1:1 with 0.9%saline,followed by the insertion of a urinary catheter.Treatment efficacy and adverse reactions were documented.Biochemical recurrence was defined as a PSA increase of over 2 ng/ml from the post-treatment nadir;imaging recurrence was identified by abnormal lesions on MRI or contrast-enhanced ultrasound.Results All 128 surgeries were successfully completed.At 6 months postoperatively,116 cases were followed.Tne median PSA was 1.58(0.56,2.95)ng/ml,which was 82.22%(65.37%,93.33%)lower than preoperative level(P<0.01).Five patients(4.31%)had biochemical recurrence,and MRI or contrast-enhanced ultrasound examinations were negative,1 patient underwent radical prostatectomy with pathology of prostate cancer,and the remaining 4 were continued to be followed up.Ninety-eight patients underwent MRI or contrast-enhanced ultrasound review,including 6 patients(6.12%)detected imaging recurrence,of which 2 patients underwent radical prostatectomy with pathology of prostate cancer,and the remaining 4 underwent endocrine therapy.The postoperative continence rate was 98.28%,and 8 patients(6.89%)had complications of class II.Conclusions Irreversible electroporation for focal treatment of localized prostate cancer has shown favorable results in terms of tumor control,safety and urinary continence.