Clinical trial NCT03591445: Is Bronchoscopy Necessary in the Preoperative Workup of GGO Lung Cancer?(ECTOP-1005)
Official title: Is Bronchoscopy Necessary in the Preoperative Workup of Ground Glass Opacity Featured Lung Cancer?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Nodule, Solitary
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Henan Cancer Hospital
name: Anhui Chest Hospital
name: Shanghai Zhongshan Hospital
name: Affiliated Hospital of Jiangnan University
name: Jilin Provincial Tumor Hospital
name: Guanxian Central Hospital of Shandong Province
name: The Third people's Hospital of Jieyang
name: Queen Mary Hospital, Hong Kong
name: Jiangdu people's hospital of Yangzhou Jiangsu Province
First posted: 2018-07-19
Enrollment: 615
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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）

Primary outcomes:
measure: Incidence rate that established surgical plan is changed by positive intra-bronchial findings
timeFrame: about 14 days
Secondary outcomes:
measure: rate of positive intra-bronchial findings
timeFrame: about 14 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
References: