Is Bronchoscopy Necessary in the Preoperative Workup of GGO Lung Cancer?(ECTOP-1005)

Not Applicable

Completed

• Conditions: Pulmonary Nodule, Solitary
• Interventions: Device: Flexible Bronchoscopy

• Registration Number: NCT03591445
• Lead Sponsor: Fudan University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-07-07
• Study First Submitted QC: 2018-07-07
• Study First Posted: 2018-07-19
• Study Start: 2018-11-06
• Primary Completion: 2019-11-30
• Study Completion: 2020-06-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 615

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

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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）

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental：Bronchoscopy	Flexible Bronchoscopy	Patients with ground glass opacity featured lung cancer who are candidates for surgeyr received the bronchoscopy examination before surgery.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
rate of positive intra-bronchial findings	about 14 days	the number of patients with positive intra-bronchial findings / total number of patients

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China