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

NCT03591445 | Completed

• 1 other identifier: Fudan_bronchoscopy
• Study Type: interventional
• Target: 615
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Nodule, Solitary

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• rate of positive intra-bronchial findings

  about 14 days

Study Arms (1)

Experimental：Bronchoscopy

EXPERIMENTAL

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

Device: Flexible Bronchoscopy

Interventions

Flexible Bronchoscopy DEVICE

Flexible Bronchoscopy

Experimental：Bronchoscopy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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）

Sponsors & Collaborators

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

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

MeSH Terms

Conditions

Solitary Pulmonary Nodule

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of thoracic surgery and multidisciplinary group of thoracic oncology

Model Details: 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.

Study Record Dates

• First Submitted: July 7, 2018
• First Posted: July 19, 2018
• Study Start: November 6, 2018
• Primary Completion: November 30, 2019
• Study Completion: June 30, 2020
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

CN (1)