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Completed

NCT Number: NCT03591445

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fudan University Shanghai Cancer Center

Shanghai, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Flexible Bronchoscopy

Device

Flexible Bronchoscopy

Primary outcomes

  1. Incidence rate that established surgical plan is changed by positive intra-bronchial findings

    Time frame: about 14 days

    The number of patients (surgical plan is changed by positive intra-bronchial findings) /Total number of patients

Secondary outcomes

  1. rate of positive intra-bronchial findings

    Time frame: about 14 days

    the number of patients with positive intra-bronchial findings / total number of patients

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jul 19, 2018
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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