腹腔镜膀胱癌根治术中采用吲哚菁绿荧光显像与标准淋巴结清扫临床疗效的随机对比研究

Efficacy of laparoscopic radical cystectomy with indocyanine green fluorescence imaging versus standard lymph node dissection: a randomized comparative study

摘要

目的 探讨吲哚菁绿荧光显像引导下腹腔镜膀胱癌根治术中区域淋巴结清扫的有效性、安全性及可行性。方法 30例肌层浸润性膀胱癌（T2/T3NxM0）患者，采用计算机随机数法分为两组，分别行吲哚菁绿荧光显像引导下腹腔镜区域淋巴结清扫术（n=15）与标准盆腔淋巴结清扫术（n=15）。比较两组患者阳性淋巴结数、手术时间、术中出血量、淋巴漏发生率及术后2年肿瘤复发转移率。结果 吲哚菁绿显像区域淋巴结清扫组阳性淋巴结（4.20±1.66）个，标准淋巴结清扫组阳性淋巴结（4.60±1.72）个，两组清扫的阳性淋巴结数差异无统计学意义（P＞0.05）；两组患者术后2年肿瘤复发转移率差异无统计学意义（P＞0.05）；吲哚菁绿显像区域淋巴结清扫组的手术时间、术中出血量、淋巴漏发生率均优于标准淋巴结清扫组（P＜0.05）。结论 吲哚菁绿荧光显像引导下腹腔镜膀胱癌根治术中区域淋巴结精准清扫术与标准淋巴结清扫术的临床效果相当，但相关并发症较少。

Abstract

Objective To investigate the efficacy, safety and feasibility of regional lymph node dissection in laparoscopic radical surgery for bladder cancer under the guidance of indocyanine green fluorescence imaging. Methods A total of 30 patients with muscle invasive bladder cancer (T2/T3NxM0) who volunteered to enter the clinical trial were randomly divided into the indocyanine green imaging guided laparoscopic regional lymph node dissection group (n=15) and the standard pelvic lymph node dissection group (n=15). The number of positive lymph nodes, operation time, intraoperative bleeding volume, incidence of lymph leakage, and tumor recurrence and metastasis rate 2-year after surgery were collected. Results The number of positive lymph nodes was (4.20±1.66) and (4.60±1.72) respectively in the indocyanine green and standard groups, with no statistically significant difference (P＞0.05). There were no statistically significant difference in the tumor recurrence and metastasis rates 2-year after surgery between the two groups (P＞0.05). However, the indocyanine green group had shorter operation time, less intraoperative bleeding volume, and lower incidence of lymphatic leakage than the standard group (P＜0.05). Conclusion Indocyanine green fluorescence imaging guided laparoscopic lymph node dissection has comparable clinical efficacy to standard lymph node dissection, but with fewer complications.

关键词

肌层浸润性膀胱癌 / 荧光显像 / 吲哚菁绿 / 盆腔淋巴结清扫术 / 膀胱癌根治术

Key words

muscle invasive bladder cancer / fluorescence imaging / indocyanine green / pelvic lymph node dissection / radical cystectomy

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基金资助

河北省医学科学研究指令性课题(20220001)