Status:
UNKNOWN
Diagnosis of Individuals With Pulmonary Nodules by Different Bronchoscopy Combination
Lead Sponsor:
Tang-Du Hospital
Collaborating Sponsors:
Changhai Hospital
The First Affiliated Hospital of Guangzhou Medical University
Conditions:
Lung Neoplasms
Early Diagnosis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study evaluates the value of different bronchoscopy combination for diagnosing peripheral pulmonary lesions suspected to be cancer. One-third of participants will receive routine bronchoscopy, wh...
Eligibility Criteria
Inclusion
- Eligible subjects are adults with solitary peripheral pulmonary lesions (mean diameter, ≤30mm and \>8mm from axial CT images) suspected to be cancer but were not pathologically confirmed.
Exclusion
- Patient has dysrhythmia or cardiovascular disease that poses a risk during exercise.
- Patient has uncontrollable hypertension (SBP \> 180mmHg).
- Patient has severe organ dysfunction (shock, severe hepatic and renal dysfunction, massive hemorrhage of upper gastrointestine, diffuse intravascular coagulation(DIC) and massive hemoptysis,etc).
- Patient has blood coagulation disorders (PT\>2 times the upper limit of normal(ULN) or Platelet(PLT)\<50000/ul）.
- Patient has severe dyspnea.
- Patient is allergic to local anesthetic.
- Patient is unable to provide informed consent.
- Patient is not an appropriate candidate for of is unable to tolerate flexible bronchoscopy procedures.
- Patient has any disease or condition that interferes with completion of initial or follow-up assessments of the effectiveness endpoints.
- Patient has demonstrated unwillingness or inability to complete screening or baseline data collection procedures.
- Patient participated in a study of an investigational drug or device within the past 30 days prior to participation in this study, or is currently participating in another clinical study.
- Female patient of childbearing potential has a positive result from a pregnancy test.
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2017
Estimated Enrollment :
3228 Patients enrolled
Trial Details
Trial ID
NCT02268162
Start Date
April 1 2015
End Date
November 1 2017
Last Update
November 16 2015
Active Locations (1)
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1
Tangdu Hospital
Xi'an, Shaanxi, China, 710038