Is Bronchoscopy Necessary in the Preoperative Workup of GGO Lung Cancer?(ECTOP-1005)
Primary Purpose
Pulmonary Nodule, Solitary
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Flexible Bronchoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Nodule, Solitary
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)
Sites / Locations
- Fudan University Shanghai Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental:Bronchoscopy
Arm Description
Patients with ground glass opacity featured lung cancer who are candidates for surgeyr received the bronchoscopy examination before surgery.
Outcomes
Primary Outcome Measures
Incidence rate that established surgical plan is changed by positive intra-bronchial findings
The number of patients (surgical plan is changed by positive intra-bronchial findings) /Total number of patients
Secondary Outcome Measures
rate of positive intra-bronchial findings
the number of patients with positive intra-bronchial findings / total number of patients
Full Information
NCT ID
NCT03591445
First Posted
July 7, 2018
Last Updated
July 18, 2023
Sponsor
Fudan University
Collaborators
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
1. Study Identification
Unique Protocol Identification Number
NCT03591445
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 6, 2018 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
Collaborators
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Nodule, Solitary
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
615 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental:Bronchoscopy
Arm Type
Experimental
Arm Description
Patients with ground glass opacity featured lung cancer who are candidates for surgeyr received the bronchoscopy examination before surgery.
Intervention Type
Device
Intervention Name(s)
Flexible Bronchoscopy
Intervention Description
Flexible Bronchoscopy
Primary Outcome Measure Information:
Title
Incidence rate that established surgical plan is changed by positive intra-bronchial findings
Description
The number of patients (surgical plan is changed by positive intra-bronchial findings) /Total number of patients
Time Frame
about 14 days
Secondary Outcome Measure Information:
Title
rate of positive intra-bronchial findings
Description
the number of patients with positive intra-bronchial findings / total number of patients
Time Frame
about 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
Country
China
12. IPD Sharing Statement
Learn more about this trial
Is Bronchoscopy Necessary in the Preoperative Workup of GGO Lung Cancer?(ECTOP-1005)
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