Zeng Da-Xiong, Cheng Zhao-Zhong, Lv Xue-Dong, Chen Cheng-Shui, Wang Ji-Wang, Browning Robert, Wang Ko-Pen, Huang Jian-An, Dutau Hervé, Kheir Fayez, Ke Ming-Yao, Jiang Jun-Hong
Department of Pulmonary and Critical Care Medicine, Suzhou Dushu Lake Hospital, Dushu Lake Hospital Affiliated to Soochow University, Medical Central of Soochow University, Suzhou, China.
Department of Pulmonary and Critical Care Medicine, the First Affiliated Hospital of Soochow University, Suzhou, China.
Transl Lung Cancer Res. 2022 Aug;11(8):1692-1701. doi: 10.21037/tlcr-22-565.
Self-expandable metallic (SEM) airway stents are an important approach to treating malignant central airway obstruction (CAO). Standard over-the-while (OTW) stent needs the guidance of a guide-wire. It should be implanted under flouroscopy or the guidance of bronchoscope visualization. In this study, we evaluated the operation time and safety between OTW stent and a novel through-the-scope (TTS) SEM airway stent.
In this multi-center, randomized, parallel-group superiority study, malignant CAO patients were enrolled randomly assigned (2:1) to the TTS stent implantation group (TTS group) or the standard OTW stent group (OTW group) in six sites across China. The entire process of all surgical procedures was recorded by video. Primary endpoint was the operation time of the airway stent implantation and secondary endpoint was the success rate of the stent implantation as well as its efficacy and safety.
From May 15, 2017, to December 30, 2018, 148 patients were enrolled from the six sites. We analyzed 134 patients (including 91 patients from the TTS group and 43 patients from the OTW group) according to the per-protocol set. There were no significant differences in the ages, genders, underlying diseases, and stenosis sites between the two groups. The operation time in the TTS group was significantly shorter than that in the OTW group (104±68 252±111 seconds, P<0.001). Compared to the OTW group, the efficacy of stent implantation (97.80% 90.70%, P=0.093) and rate of first-time successful stent implantation (78.02% 74.42%, P=0.668) were higher in the TTS group, but did not reach statistically significance. The rates of granulation (28.57% 41.86%, P=0.128) and restenosis (15.38% 30.23%, P=0.064) in the TTS group were slightly lower as compared with the OTW group without achieving statistical significance.
The TTS stent implantation procedure time was significantly shorter than that of the OTW airway stent with similar efficacy and complications, which might reduce the risk and flexibility of stent implantation.
Chinese Clinical Trial Registry ChiCTR-IOR-17011431.
自膨式金属（SEM）气道支架是治疗恶性中央气道阻塞（CAO）的重要方法。标准的全程置入式（OTW）支架需要导丝引导，应在荧光透视或支气管镜直视引导下植入。在本研究中，我们评估了OTW支架与新型经镜式（TTS）SEM气道支架在手术时间和安全性方面的差异。
在这项多中心、随机、平行组优势研究中，恶性CAO患者在中国六个地点被随机分配（2:1）至TTS支架植入组（TTS组）或标准OTW支架组（OTW组）。所有手术过程均通过视频记录。主要终点是气道支架植入的手术时间，次要终点是支架植入的成功率及其有效性和安全性。
从2017年5月15日至2018年12月30日，六个地点共纳入148例患者。我们根据符合方案集分析了134例患者（包括TTS组91例患者和OTW组43例患者）。两组患者在年龄、性别、基础疾病和狭窄部位方面无显著差异。TTS组的手术时间明显短于OTW组（104±68对252±111秒，P<0.001）。与OTW组相比，TTS组的支架植入有效性（97.80%对90.70%，P=0.093）和首次成功支架植入率（78.02%对74.42%，P=0.668）更高，但未达到统计学意义。TTS组的肉芽形成率（28.57%对41.86%，P=0.128）和再狭窄率（15.38%对30.23%，P=0.064）略低于OTW组，但未达到统计学意义。
TTS支架植入手术时间明显短于OTW气道支架，且有效性和并发症相似，这可能降低支架植入的风险并提高灵活性。
中国临床试验注册中心ChiCTR-IOR-17011431
