荧光腹腔镜与高清腹腔镜根治性前列腺切除术+扩大盆腔淋巴结清扫治疗局部高危前列腺癌的疗效对比

Comparative study of fluorescence vs.high-definition laparoscopy in extended pelvic lymph node dissection plus radical prostatectomy for patients with locally advanced prostate cancer

目的比较荧光腹腔镜根治性前列腺切除术(FLRP)与高清腹腔镜根治性前列腺切除术(HD-LRP)+扩大盆腔淋巴结清扫(ePLND)治疗局部高危前列腺癌(LAPCa)的疗效。方法前瞻性选取2015年7月至2018年4月我院收治的LAPCa患者进行研究。纳入标准:前列腺穿刺活检病理确诊为前列腺腺癌,Gleason评分均>7分;结合盆腔MRI或68Ga-PSMA-PET/CT等影像学资料,术前诊断临床分期≥cT3a期。排除标准:既往行内分泌治疗或化疗;术前影像学检查提示骨转移、远处淋巴结转移及内脏转移;拒绝手术;研究者认为的其他与治疗方案不符的情况。采用随机数字表法将患者分为研究组和对照组。研究组行FLRP+ePLND,术前30min在经直肠B超探头引导下,经会阴向前列腺两侧叶腺体内各注射5mg吲哚菁绿行淋巴造影,术中使用荧光探头,可见造影淋巴结呈绿色荧光,沿Eplnd区域行髂内、髂外、闭孔、骶前和髂总动脉旁淋巴结示踪清扫。对照组行HD-LRP+Eplnd,并增做骶前和髂总动脉旁淋巴结清扫。两组的根治性前列腺切除术方法相同。术后随访前列腺癌特异性抗原(PSA)和影像学检查,比较两组的手术时间、出血量、淋巴结清扫数量及阳性数量、并发症发生情况、生化复发率和2年无肿瘤转移生存率(MFSR)。结果本研究共纳入51例患者,研究组21例,对照组30例。研究组和对照组的年龄分别为(66.4±7.7)岁和(66.8±7.4)岁,体重指数分别为(24.3±1.5)kg/m^2和(25.1±1.5)kg/m^2,PSA分别为(23.5±16.8)ng/ml和(26.0±20.1)ng/ml,术前穿刺Gleason评分分别为(8.1±1.0)分和(7.9±0.9)分,差异均无统计学意义(P>0.05)。研究组和对照组的手术时间分别为(179±35)min和(205±46)min,Eplnd时间分别为(45.9±4.6)min和(56.4±3.2)min,清扫淋巴结数量分别为583枚和663枚,每例患者清扫淋巴结数量分别为(27.7±5.6)枚和(22.1±5.6)枚,差异均有统计学意义(P<0.05)。研究组和对照组淋巴结阳性例数分别为8例(38.1%)和9例(30.0%)(P=0546),阳性淋巴结数量占清扫总数的比例分别为3.2%(19/583)和3.4%(23/663)(P=0.838),差异均无统计学意义。研究组和对照组均未发生严重并发症,对照组4例出现淋巴漏,两组差异有统计学意义(P<0.05)。51例随访20个月(7~33)个月。研究组和对照组生化复发率分别为4.7%(1/21)和26.7%(8/30);研究组无临床复发患者,对照组4例(13.3%)临床复发,两组差异均无统计学意义(P>0.05)。生存分析提示研究组和对照组的2年MFSR分别为95.3%和73.7%(P=0.04),无病生存率分别为100.0%和86.7%(P=0.04),差异均有统计学意义。结论与HD-LRP+Eplnd比较,对LAPCa患者行FLRP+Eplnd能提高盆腔淋巴结清扫率,缩短手术时间,减少并发症,术后控瘤效果满意。

Objective To compare the efficacy of extended pelvic lymph node dissection(ePLND)and oncological outcome by fluorescence laparoscopic radical prostatectomy(FLRP)versus high-definition laparoscopic radical prostatectomy(HD-LRP)for men with locally advanced prostate cancer(LAPCa).Methods In a prospective trial,we recruited 51 patients with T3a-bNxM0 prostate cancer from July 2015 to April 2018.Patients were assigned to study group or control group according to random number method,and were underwent either FLRP+ePLND or HD-LRP+ePLND.21 in the study group were injected with 5 mg of indocyanine green(ICG)into the bilateral lobes of the prostate transperineally guiled by transrectal ultrasound 30 min before surgery for lymphography.During the surgical procedure a fluorescence laparoscope,optimized for detection in the near infrared range,was used to visualize the lymph nodes(green fluorescent)in the dissection region in the study group while a common laparoscopy introduced in control one.Lymph nodes were removed in the external iliac vessiles,internal iliac artery,obturator fossa regions,common iliac regions and presacral regions in both groups.Radical prostatectomy was completed in the both groups by similar steps.The operation time,blood loss,number of removed lymph nodes and positive lymph nodes,complication rate,biochemical recurrence(BCR)and metastasis free survival rates in 2 years were recorded and compared in the two groups.Results 51 eligible patients were selected,including 21 in the study group and 30 in the control group.The mean age of biopsy of study group and control one were(66.4±7.7)and(66.8±7.4),the mean age PSA(23.5±16.8)ng/ml and(26.0±20.1)ng/ml,the mean Gleason score of biopsy(8.1±1.0)and(7.9±0.9)respectively,and there was no statistical significant difference between two groups.The mean operation time of study group and control one were(45.9±4.6)min and(56.4±3.2)min,the mean removed lymph nodes were(27.7±5.6)and(22.1±5.6)respectively,and there was statistical significant difference between two groups(all P<0.05).Lymph nodes invasion in pathology were reported in 8 cases(38.1%)in the study groups while 9(30.0%)in the control one;the proportion of positive lymph node(metastasis)were 3.2%(19/583)and 3.4%(23/663)in the two groups respectively and no statistically significant difference was noted between the two groups.Lymphorrhagia occurred in 4 cases in the control group,and there was no serious complications in both groups.The median follow-up time was 20(7-33)month and during this time,BCR observed of 1(4.7%)in the study group and 8(26.7%)in the control;meanwhile,the MFSR was recorded of 100.0%(0)in the study group and 86.7%(4)in the control one,showing a statistically significant difference between the two groups(P=0.04).Conclusions Comparing with LRP,FLRP achieved better results of LN dissection,which will improve oncological outcomes.