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超声能量在开胸肺叶切除术中肺动脉封闭:I 期临床试验。

Pulmonary artery sealing with ultrasonic energy in open lobectomy: A phase I clinical trial.

机构信息

Division of Thoracic Surgery, Department of Surgery, Centre Hospitalier de l'Université de Montréal Endoscopic Tracheobronchial and Oesophageal Center (CETOC), Endoscopic Tracheobronchial and Oesophageal Center, University of Montréal, Montréal, Québec, Canada.

Division of Thoracic Surgery, Department of Surgery, Centre Hospitalier de l'Université de Montréal Endoscopic Tracheobronchial and Oesophageal Center (CETOC), Endoscopic Tracheobronchial and Oesophageal Center, University of Montréal, Montréal, Québec, Canada.

出版信息

J Thorac Cardiovasc Surg. 2017 Jun;153(6):1600-1607. doi: 10.1016/j.jtcvs.2016.12.049. Epub 2017 Feb 9.

Abstract

OBJECTIVE

Pulmonary artery branch sealing in video-assisted thoracoscopic surgical lobectomy is usually achieved with vascular endostaplers. Iatrogenic pulmonary artery injury may be caused by endostaplers. We evaluated the safety of pulmonary artery sealing with an ultrasonic energy vessel-sealing device in a phase I clinical trial evaluating in vivo safety of the device during open lobectomy.

METHODS

Patients scheduled to undergo elective open (thoracotomy) pulmonary lobectomy were prospectively enrolled. Target sample size was 10 patients. Pulmonary artery diameter was measured intraoperatively. All branches ≤7 mm were divided with an ultrasonic energy vessel-sealing device. The remainder of the lobectomy was performed in a standard fashion. Intraoperative and postoperative bleeding were strictly recorded.

RESULTS

Eighteen patients were prospectively enrolled. Eight patients were not amenable to pulmonary artery sealing with the device. In the 10 patients included in the analysis, a total of 14 pulmonary arteries were sealed with the ultrasonic device. The mean vessel diameter was 5 mm (range, 2-7 mm). One patient underwent reoperation for bronchial artery bleeding (vessel not sealed with device). There was no intra- or postoperative bleeding related to ultrasonic pulmonary artery sealing. There was no postoperative mortality.

CONCLUSIONS

Pulmonary artery sealing for vessels with diameter ≤7 mm was safely achieved with an ultrasonic energy vessel-sealing device in open lobectomy. The use of ultrasonic energy vessel-sealing devices in video-assisted thoracoscopic surgical lobectomy may have the advantage of making small, short, pulmonary artery branch sealing safer than with vascular endostaplers. Further studies are necessary before widespread application in lobectomy, including video-assisted thoracoscopic surgical lobectomy.

摘要

目的

在电视辅助胸腔镜手术肺叶切除术中,通常使用血管吻合器来封闭肺动脉分支。吻合器可能会导致医源性肺动脉损伤。我们在一项评估该设备在开放性肺叶切除术中体内安全性的 I 期临床试验中,评估了使用超声能量血管密封装置封闭肺动脉的安全性。

方法

前瞻性纳入计划接受择期开放性(开胸)肺叶切除术的患者。目标样本量为 10 例。术中测量肺动脉直径。所有直径≤7mm 的分支均采用超声能量血管密封装置分离。其余的肺叶切除术采用标准方法进行。严格记录术中及术后出血情况。

结果

前瞻性纳入 18 例患者。8 例患者不适合使用该装置进行肺动脉封闭。在纳入分析的 10 例患者中,共使用超声设备封闭了 14 条肺动脉。平均血管直径为 5mm(范围,2-7mm)。1 例患者因支气管动脉出血(未用器械封闭的血管)而行再次手术。无与超声肺动脉封闭相关的术中或术后出血。无术后死亡。

结论

在开放性肺叶切除术中,对于直径≤7mm 的血管,使用超声能量血管密封装置可安全封闭肺动脉。在电视辅助胸腔镜手术肺叶切除术中使用超声能量血管密封装置可能具有优势,可使小而短的肺动脉分支的封闭比血管吻合器更安全。在包括电视辅助胸腔镜手术肺叶切除术在内的肺叶切除术中广泛应用之前,还需要进一步研究。

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