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肋下单孔机器人解剖性肺切除术:一项试点试验。

Subcostal uniportal robotic anatomic lung resection: A pilot trial.

作者信息

Cheng Chuan, Tagkalos Evangelos, Ng Chong Beng, Hsu Ya-Chun, Huang Yu Ya, Wu Ching Feng, Chao Yin-Kai

机构信息

Division of Thoracic Surgery, New Taipei Municipal Tu-Cheng Hospital, New Taipei City, Taiwan.

Division of Thoracic Surgery, Chang Gung Memorial Hospital-Linkou, Chang Gung University, Taoyuan, Taiwan.

出版信息

JTCVS Tech. 2024 Apr 28;25:160-169. doi: 10.1016/j.xjtc.2024.01.024. eCollection 2024 Jun.

Abstract

OBJECTIVE

Robot-assisted thoracoscopic surgery typically necessitates the use of multiple ports. The new single-port robotic system (da Vinci SP system) platform is designed to perform uniportal surgery. The purpose of this clinical trial is to evaluate the feasibility, efficacy, and safety of the da Vinci SP system when used for anatomical lung resection.

METHODS

Patients diagnosed with clinical stage I lung cancer requiring anatomical lung resections were considered eligible for this trial. The primary outcome measure was the rate of conversion, whereas the secondary objective focused on assessing the incidence of perioperative complications.

RESULTS

The study included 35 patients with a median age of 63 years (range, 48-74 years). Of these, 30 underwent lobectomy and 5 received segmentectomy. All surgeries were successfully performed using a subcostal approach, except for 1 patient, who required a thoracotomy conversion due to bleeding (conversion rate: 2.9%). The median docking time was 2 minutes (range, 1-8 minutes). For the 34 patients who completed uniportal surgery, the median total operating time was 194 minutes (range, 63-405 minutes), whereas the console time was 153 minutes (range, 93-267 minutes). The median number of harvested nodes was 13 (range, 5-37), while the median number of nodal stations was 6 (rang, 4-8). There were no in-hospital fatalities, and the median postoperative stay was 3 days (range, 2-12 days).

CONCLUSIONS

This study demonstrates the feasibility and safety of using the da Vinci SP system for anatomical lung resection through a subcostal approach.

CLINICALTRIALSGOV IDENTIFIER

NCT05535712.

摘要

目的

机器人辅助胸腔镜手术通常需要使用多个端口。新型单端口机器人系统(达芬奇SP系统)平台旨在进行单孔手术。本临床试验的目的是评估达芬奇SP系统用于解剖性肺切除时的可行性、有效性和安全性。

方法

被诊断为临床I期肺癌且需要进行解剖性肺切除的患者被认为符合本试验条件。主要结局指标是中转率,而次要目标侧重于评估围手术期并发症的发生率。

结果

该研究纳入了35例患者,中位年龄为63岁(范围48 - 74岁)。其中,30例行肺叶切除术,5例行肺段切除术。除1例因出血需要中转开胸手术外(中转率:2.9%),所有手术均采用肋下入路成功完成。中位对接时间为2分钟(范围1 - 8分钟)。对于完成单孔手术的34例患者,中位总手术时间为194分钟(范围63 - 405分钟),而控制台操作时间为153分钟(范围93 - 267分钟)。中位清扫淋巴结数量为13个(范围5 - 37个),中位淋巴结站数为6个(范围4 - 8个)。无院内死亡病例,中位术后住院时间为3天(范围2 - 12天)。

结论

本研究证明了通过肋下入路使用达芬奇SP系统进行解剖性肺切除的可行性和安全性。

临床试验注册号

NCT05535712。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2722/11184444/dd6ce8a310f5/ga1.jpg

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