Diagnosis of Individuals With Pulmonary Nodules by Different Bronchoscopy Combination

Not Applicable

• Conditions: Bronchoscopy; Lung Neoplasms; Early Diagnosis

• Registration Number: NCT02268162
• Lead Sponsor: Tang-Du Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-15
• Study First Submitted QC: 2014-10-15
• Study First Posted: 2014-10-20
• Study Start: 2015-04
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-13
• Last Update Posted: 2015-11-16
• Primary Completion: 2017-11
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3228

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
hospitalization costs	7 days	the hospitalization costs for a participant
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
Number of participants with adverse events or serious adverse events	2 weeks	Number of participants with any adverse events or serious adverse events

Trial Locations

Locations (1)

Tangdu Hospital; 🇨🇳 Xi'an, Shaanxi, China