Is Bronchoscopy Necessary in the Preoperative Workup of Ground Glass Opacity Featured Lung Cancer?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 615
- 试验地点
- 1
- 主要终点
- Incidence rate that established surgical plan is changed by positive intra-bronchial findings
研究概览
简要总结
This study is one of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1005). It aims to evaluate the role of flexible bronchoscopy in the pre-operative workup of ground glass opacity featured lung cancer. All enrolled patients receive the flexible bronchoscopy examination before surgery. Investigators observe the intra-bronchial findings of bronchoscopy and the impact of these findings on established surgical plan.
详细描述
The appropriateness of routine use of bronchoscopy in the operative workup of a solitary pulmonary nodule（SPN） is debatable. Options expressed in the literature vary from routine preoperative bronchoscopy having no role in obtaining tissue diagnosis in small SPNs to it begin very useful in determining underlying etiology and surgical strategy. The American College of Chest Physicians（ACCP）guidelines recommend bronchoscopy only if air-bronchogram is present or if operator has expertise with newer guided techniques. Previous study showed that bronchoscopy is not indicated in SPNs that present with ground-glass opacity on CT. The purpose of this analysis is to define that role by examining in GGO patients （1）intra-bronchial findings （2）impact of these findings on established surgical plan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ground glass opacity pulmonary nodule diagnosed by thoracic CT
- •karnofsky performance status ≥60
- •No surgical contraindication
- •Patients who sign the informed consent
- •Pre-operation clinical stage :T1abcN0M0
- •Age:18-80 years old
排除标准
- •Central lung tumor diagnosed by CT
- •Tracheal or bronchus deformity diagnosed by CT
- •Tracheal or bronchus disease history
- •Severe smoking history （smoking index ≥400/year）
研究组 & 干预措施
Experimental：Bronchoscopy
Patients with ground glass opacity featured lung cancer who are candidates for surgeyr received the bronchoscopy examination before surgery.
干预措施: Flexible Bronchoscopy (Device)
结局指标
主要结局
Incidence rate that established surgical plan is changed by positive intra-bronchial findings
时间窗: about 14 days
The number of patients （surgical plan is changed by positive intra-bronchial findings） /Total number of patients
次要结局
- rate of positive intra-bronchial findings(about 14 days)
研究者
Haiquan Chen
Director of Department of thoracic surgery and multidisciplinary group of thoracic oncology
Fudan University