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

Pulmonary Nodule, Solitary Clinical Trial

Official title:

Is Bronchoscopy Necessary in the Preoperative Workup of Ground Glass Opacity Featured Lung Cancer?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03591445
• Other study ID #: Fudan_bronchoscopy
• Status: Completed
• Phase: N/A
• Start date: November 6, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2023
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 615
• Est. completion date: June 30, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Pulmonary Nodules
• Pulmonary Nodule, Solitary
• Solitary Pulmonary Nodule

Intervention

Device:
• Flexible Bronchoscopy
Flexible Bronchoscopy

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (10)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	about 14 days
Secondary	rate of positive intra-bronchial findings	the number of patients with positive intra-bronchial findings / total number of patients	about 14 days