Is Bronchoscopy Necessary in the Preoperative Workup of Ground Glass Opacity Featured Lung Cancer?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Fudan University
- Enrollment
- 615
- Locations
- 1
- Primary Endpoint
- Incidence rate that established surgical plan is changed by positive intra-bronchial findings
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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）
Outcomes
Primary Outcomes
Incidence rate that established surgical plan is changed by positive intra-bronchial findings
Time Frame: about 14 days
The number of patients （surgical plan is changed by positive intra-bronchial findings） /Total number of patients
Secondary Outcomes
- rate of positive intra-bronchial findings(about 14 days)
Investigators
Haiquan Chen
Director of Department of thoracic surgery and multidisciplinary group of thoracic oncology
Fudan University