上尿路尿路上皮癌肾输尿管切除术时腹膜外腹腔镜扩大腹膜后淋巴结清扫术的肿瘤学结局及安全性的前瞻性临床试验
Prospective Clinical Trial of the Oncologic Outcomes and Safety of Extraperitoneal Laparoscopic Extended Retroperitoneal Lymph Node Dissection at Time of Nephroureterectomy for Upper Tract Urothelial Carcinoma.
作者信息
Huang Jiwei, Qian Hongyang, Yuan Yichu, Cai Xingyun, Chen Yonghui, Zhang Jin, Kong Wen, Wu Xiaorong, Cao Ming, Huang Yiran, Chen Haige, Xue Wei
机构信息
Department of Urology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Department of Urology, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
出版信息
Front Oncol. 2022 Feb 24;12:791140. doi: 10.3389/fonc.2022.791140. eCollection 2022.
PURPOSE
To determine the safety and feasibility of extraperitoneal laparoscopic extended lymph node dissection (LND) at the time of extraperitoneal laparoscopic radical nephroureterectomy (RNU).
MATERIALS AND METHODS
Between May 2018 and March 2019, 39 patients with upper tract urothelial carcinoma (UTUC) received extraperitoneal laparoscopic RNU and concomitant extraperitoneal laparoscopic extended LND. All patients were followed for at least 90 days. Perioperative and pathological data including nodal status and perioperative complications were collected.
RESULTS
Among all 39 patients, 12 patients had pT1, 6 had pT2, 20 had pT3 disease, and 1 had T4 disease. The median (range) lymph node count was 10 (5-22), with 8 patients having pathologically proven lymph node metastasis. The median (range) operating time was 225 (165-430) min, and the median estimated blood loss was 200 (60-800) ml. The median postoperative hemoglobin loss was 1.6 (0-4.2) g/dl. The median (range) postoperative hospital stays were 6 (3-26) days. Overall, 7 patients experienced minor (Clavien Grade I-II) postoperative complications with five patients having Clavien Grade I complications and two patients having Clavien Grade II complications. No major complication (Clavien grade III-IV) occurred. With a median follow-up of 38 months, a total of 8 patients (20.5%) developed local or distant recurrence and no regional LNs where extended LND were performed had recurrence.
CONCLUSIONS
The present prospective study demonstrated that extraperitoneal laparoscopic extended LND during extraperitoneal laparoscopic RNU for UTUC is a feasible and safe procedure which provides minimal invasion, rapid recovery, and potentially lower risk of regional LN recurrence. Larger prospective clinical trials with survival endpoints are needed to further determine its potential therapeutic benefits.
TRIAL REGISTRATION
ClinicalTrials.gov identifier NCT03544437 www.clinicaltrials.gov.
目的
确定腹膜外腹腔镜根治性肾输尿管切除术（RNU）时行腹膜外腹腔镜扩大淋巴结清扫术（LND）的安全性和可行性。
材料与方法
2018年5月至2019年3月，39例上尿路尿路上皮癌（UTUC）患者接受了腹膜外腹腔镜RNU并同期行腹膜外腹腔镜扩大LND。所有患者均随访至少90天。收集围手术期和病理数据，包括淋巴结状态和围手术期并发症。
结果
39例患者中，12例为pT1期，6例为pT2期，20例为pT3期，1例为T4期。淋巴结计数中位数（范围）为10（5 - 22），8例患者经病理证实有淋巴结转移。手术时间中位数（范围）为225（165 - 430）分钟，估计失血量中位数为200（60 - 800）毫升。术后血红蛋白下降中位数为1.6（0 - 4.2）克/分升。术后住院时间中位数（范围）为6（3 - 26）天。总体而言，7例患者出现轻微（Clavien I - II级）术后并发症，其中5例为Clavien I级并发症，2例为Clavien II级并发症。无严重并发症（Clavien III - IV级）发生。中位随访38个月，共有8例患者（20.5%）出现局部或远处复发，行扩大LND的区域淋巴结无复发。
结论
本前瞻性研究表明，腹膜外腹腔镜RNU治疗UTUC时同期行腹膜外腹腔镜扩大LND是一种可行且安全的手术，具有微创、恢复快和区域淋巴结复发风险可能较低的特点。需要更大规模的以生存为终点的前瞻性临床试验来进一步确定其潜在的治疗益处。
试验注册
ClinicalTrials.gov标识符NCT03544437 （www.clinicaltrials.gov）
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