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

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Nodule, Solitary
• Intervention / Treatment: Device: Flexible Bronchoscopy

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 Type: Interventional
• Enrollment (Actual): 615
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: YiLiang Zhang; Phone Number: 18017317284; Email: ilya616@216.com
• Study Contact Backup: Name: Zhang; Email: ilya616@126.com

Study Locations

• China
  • Shanghai, China
    • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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）

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of positive intra-bronchial findings	the number of patients with positive intra-bronchial findings / total number of patients	about 14 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2018
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: July 7, 2018
• First Submitted That Met QC Criteria: July 7, 2018
• First Posted (Actual): July 19, 2018

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Multiple Pulmonary Nodules; Solitary Pulmonary Nodule
• Other Study ID Numbers: Fudan_bronchoscopy

Drug and device information, study documents

• 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