Preservation vs. Dissection of Inferior Pulmonary Ligament for Thoracoscopic Upper Lobectomy: A Prospective Randomized Controlled Trial（IPLP FJUNION）
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Change in bronchial angle
研究概览
简要总结
Many thoracic surgeons tend to dissect the inferior pulmonary ligament (IPL) during upper lobectomy, which in theory reduces the free space in the upper thoracic cavity by increasing the mobility of the residual lung. However, the dissection of IPL may lead to bronchial deformation, stenosis, obstruction or lobe torsion, and distortion. Some studies have found that stenosis might be associated with chronic dry cough and shortness of breath, and could result in a significant decline in lung function. Moreover, the dissection of IPL may lead to greater surgical trauma and increase the incidence of complications. Therefore, this study tries to identify whether we should dissect or preserve the inferior pulmonary ligament during the thoracoscopic upper lobectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old < age < 70 years old;
- •Meet the indications for thoracoscopic left/right upper lobectomy;
- •Gave informed consent and were willing to undergo thoracoscopic left/right upper lobectomy;
- •Preoperative pulmonary function test: FEV1>1L and FEV1>60% of the predicted value;
- •Preoperative ECOG score of 0-1;
- •Preoperative ASA score I-II.
排除标准
- •Inferior mediastinal lymphadenopathy was found in preoperative screening;
- •Found that other lobe operations were required at the same time due to multiple lesions in the preoperative discussion;
- •Pregnant or lactating women;
- •Suffering from severe mental illness;
- •History of thoracic surgery (including intrathoracic surgery only, excluding surface surgery such as mastectomy);
- •History of unstable angina or myocardial infarction within the past six months;
- •History of cerebral infarction or cerebral hemorrhage within the past six months;
- •History of continuous systemic corticosteroid therapy within the past month;
- •Abnormal coagulation function, bleeding tendency, or receiving antithrombotic or antiplatelet therapy recently;
- •Suffering from severe liver, kidney, and other systemic diseases;
- •Other situations that are not suitable for surgery.
结局指标
主要结局
Change in bronchial angle
时间窗: 6 months after the operation
Change in bronchial angle of each arm(measured by coronal CT)
Change in lung volume
时间窗: 6 months after the operation
Change in lung volume of each arm(measured by Mimics Research 21.0 software)
次要结局
- Apical dead space(Within 6 months after the operation)
- Closed thoracic drainage tube rentention time(During the postoperative hospital stay)
- Pathologic cancer stage(After the operation)
- Atrial fibrillation(During the postoperative hospital stay)
- Operation time(During the operation)
- Disposable drainage catheter retention time(Within one month after the operation)
- Pleural effusion(Within 6 months after the operation)
- Lung infection(Within 6 months after the operation)
- Postoperative hospital stay(During the postoperative hospital stay)
- Histologic diagnosis(After the operation)