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Is Bronchoscopy Necessary in the Preoperative Workup of GGO Lung Cancer?

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ClinicalTrials.gov Identifier: NCT03591445
Recruitment Status : Recruiting
First Posted : July 19, 2018
Last Update Posted : October 29, 2019
Sponsor:
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
Information provided by (Responsible Party):
Haiquan Chen, Fudan University

Study Description
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Brief Summary:
This study 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.

Condition or disease Intervention/treatment Phase
Pulmonary Nodule, Solitary Device: Flexible Bronchoscopy Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 612 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Is Bronchoscopy Necessary in the Preoperative Workup of Ground Glass Opacity Featured Lung Cancer?
Actual Study Start Date : November 6, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental：Bronchoscopy
Patients with ground glass opacity featured lung cancer who are candidates for surgeyr received the bronchoscopy examination before surgery.
 Device: Flexible Bronchoscopy
Flexible Bronchoscopy


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. rate of positive intra-bronchial findings [ Time Frame: about 14 days ]
    the number of patients with positive intra-bronchial findings / total number of patients


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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）
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03591445


Contacts
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Contact: YiLiang Zhang 18017317284 ilya616@216.com
Contact: Zhang ilya616@126.com

Locations
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China
Fudan University Shanghai Cancer Center Recruiting
Shanghai, China
Contact: Haiquan Chen    +8602164430399    hqchen1@yahoo.com   
Principal Investigator: Haiquan Chen, MD         
Sponsors and Collaborators
Fudan University
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
More Information
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Responsible Party: Haiquan Chen, Director of Department of thoracic surgery and multidisciplinary group of thoracic oncology, Fudan University
ClinicalTrials.gov Identifier: NCT03591445    
Other Study ID Numbers: Fudan_bronchoscopy
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019

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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
Additional relevant MeSH terms:
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Multiple Pulmonary Nodules
Solitary Pulmonary Nodule
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases