Diagnosis of Individuals With Pulmonary Nodules by Different Bronchoscopy Combination

Tang-Du Hospital

Status: Unknown

Conditions: Lung Neoplasms; Early Diagnosis; Bronchoscopy

Treatments: Procedure: guiding equipments

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02268162

201402024 (Other Grant/Funding Number)

lungcancer diagnosis

Details and patient eligibility

About

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.

Enrollment: 3,228 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,228 participants in 3 patient groups

Routine Bronchoscopy

No Intervention group

Description:

Participants in the group will receive routine bronchoscopy.

Routine Bronchoscopy with a guiding equipment

Experimental group

Description:

Participants in the group will receive routine bronchoscopy combined with a guiding equipment. These guiding equipments include virtual bronchoscopic navigation(VBN), endobronchial ultrasonography with a guide sheath(EBUS-GS) and fluoroscopy.

Treatment:

Procedure: guiding equipments

Routine Bronchoscopy with two or more guiding equipments

Experimental group

Description:

Participants in the group will receive routine 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.

Treatment:

Procedure: guiding equipments