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

Sponsor

Fudan University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03591445

Collaborator

Henan Cancer Hospital (Other), Anhui Chest Hospital (Other), Shanghai Zhongshan Hospital (Other), Affiliated Hospital of Jiangnan University (Other), Jilin Provincial Tumor Hospital (Other), Guanxian Central Hospital of Shandong Province (Other), The Third people's Hospital of Jieyang (Other), Queen Mary Hospital, Hong Kong (Other), Jiangdu people's hospital of Yangzhou Jiangsu Province (Other)

612

Enrollment

Location

Arm

49.8

Anticipated Duration (Months)

12.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Anticipated 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.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 :

Nov 6, 2018

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

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

Primary Outcome Measures

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 Outcome Measures

rate of positive intra-bronchial findings [about 14 days]
the number of patients with positive intra-bronchial findings / total number of patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Shanghai Cancer Center	Shanghai		China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Jul 19, 2018

Last Update Posted:

Oct 29, 2019

Last Verified:

Oct 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Multiple Pulmonary Nodules

Solitary Pulmonary Nodule

Study Results

No Results Posted as of Oct 29, 2019