Pulmonary Nodule, Solitary
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEFlexible Bronchoscopy
Flexible Bronchoscopy
Sponsors
Henan Cancer Hospital
Anhui Chest Hospital
Shanghai Zhongshan Hospital
Affiliated Hospital of Jiangnan University
Jilin Provincial Tumor Hospital
Guanxian Central Hospital of Shandong Province
The Third people's Hospital of Jieyang
Queen Mary Hospital, Hong Kong
Jiangdu people's hospital of Yangzhou Jiangsu Province
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
We hypothesized incidence rate that bronchoscopic findings would have changed the rate of established surgical plans as less than 2.0% (P0), then preoperative bronchoscopy examination would have limited impact on the surgical plan for GGO featured lung cancer; If bronchoscopic findings would have changed the rate of established surgical plans as more than 4.0% (P1), then bronchoscopy examination would be regarded as one routine preoperative work-up. Null hypothesis: H0: P≤P0; Alternative hypothesis: HA: P ≥ P1. α = 0.05, 1-β = 0.9. Using Simon's two-stage approach, the first phase enrolled 612 patients. If ≥18 patients supported the alternative hypothesis, they entered the second phase, otherwise the trial was terminated; the second phase enrolled 451 patients. If the patient number who eventually changes the surgical plan is ≤27, the null hypothesis is accepted, that preoperative bronchoscopy examination would be unnecessary for GGO featured lung cancer.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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）
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate that established surgical plan is changed by positive intra-bronchial findings | about 14 days | The number of patients （surgical plan is changed by positive intra-bronchial findings） /Total number of patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rate of positive intra-bronchial findings | about 14 days | the number of patients with positive intra-bronchial findings / total number of patients |
Countries
China
Outcome results
None listed