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

Fudan University

Status: Completed

Conditions: Pulmonary Nodule, Solitary

Treatments: Device: Flexible Bronchoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT03591445

Fudan_bronchoscopy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 615 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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）

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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615 participants in 1 patient group

Experimental：Bronchoscopy

Experimental group

Description:

Patients with ground glass opacity featured lung cancer who are candidates for surgeyr received the bronchoscopy examination before surgery.

Treatment:

Device: Flexible Bronchoscopy