Bronchoscopy, Early Diagnosis, Lung Neoplasms
Conditions
Keywords
Lung Neoplasms, Bronchoscopy, Virtual Bronchoscopic Navigation(VBN), Fluoroscopy, Endobronchial Ultrasonography with a Guide Sheath(EBUS-GS), Diagnosis
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, while one-third of participants will receive bronchoscopy combined with a guiding equipment and the other one-third of participants will receive bronchoscopy combined with two or more guiding equipments. These guiding equipments include virtual bronchoscopic navigation(VBN), endobronchial ultrasonography with a guide sheath(EBUS-GS) and fluoroscopy.
Interventions
PROCEDUREguiding equipments
The guiding equipments including VBN, EBUS-GS and fluoroscopy guide a bronchoscope along the bronchial route to a peripheral pulmonary lesion.
Sponsors
Changhai Hospital
The First Affiliated Hospital of Guangzhou Medical University
Xinqiao Hospital of Chongqing
China Meitan General Hospital
Micro-Tech (Nanjing) Co., Ltd.
Tang-Du Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield for pulmonary peripheral lesions | 7 days | The diagnostic yield for individuals with pulmonary peripheral lesions examined by bronchoscopy with or without guiding equipments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| length of operation time using bronchoscopy or bronchoscopy combination | 30 minutes | The operation time using bronchoscopy or bronchoscopy combination to examine a participant |
| length of stay in hospital | 7 days | length of stay in hospital for a participant |
| hospitalization costs | 7 days | the hospitalization costs for a participant |
| Number of participants with adverse events or serious adverse events | 2 weeks | Number of participants with any adverse events or serious adverse events |
Countries
China
Contacts
Primary ContactLei Pan, MD & PhD
Backup ContactYandong Nan, MD
Outcome results
None listed