Clinical trial NCT02109458: Pilot Study of Navigational Bronchoscopy and Transthoracic Needle Biopsy
Official title: Navigational Bronchoscopy and Transthoracic Needle Biopsy for the Diagnosis of Peripheral Pulmonary Nodules: A Safety and Feasibility Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Pulmonary Nodules
Keywords: Lung nodule biopsy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Veran Medical Technologies
First posted: 2014-04-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to evaluate the feasibility and safety of navigation guided virtual transthoracic needle biopsy combined with navigational bronchoscopy for the diagnosis of peripheral pulmonary nodules (PPN).

Detailed description: Accessing peripheral pulmonary nodules is problematic because they are often not visible endobronchially, not large enough to be visualized by x-ray fluoroscopy for transbronchial biopsy (TBBx), and/or do not lie within an accessible airway. In this study, investigators hope to evaluate new technologies to aid in PPN biopsy using navigation bronchoscopy (NB) combined with navigation transthoracic needle aspiration (N-TTNA) sampling of a PPN.

Patients meeting inclusion criteria who consent will undergo a convex Endobronchial Ultrasound (EBUS) bronchoscopy for evaluation and sampling of the mediastinum and hilum. Following this, NB will be performed with an ultrathin bronchoscope (4mm outer diameter with a 2 mm working channel) with R-EBUS and fluoroscopy. If the lesion is localized by NB and/or radial EBUS in conjunction with NB, TBBX will be taken. At the conclusion of TBBX sampling, a fluoroscopic evaluation to assess for the presence of pneumothorax will be performed and if one is present, appropriate clinical measures will be taken at the discretion of the treating team (tube thoracostomy, observation, etc.) and no further sampling techniques will be utilized. If the lesion was not able to be localized via NB and/or the physician feels insufficient sample was acquired for diagnosis and there is no evidence of pneumothorax, the patient will undergo N-TTNA at the same PPN during the same procedure time. It is envisioned that between 8-12 patients will require a N-TTNA to complete diagnosis.

Eligibility criteria: Inclusion criteria:

* Target patient population: Patients with a peripheral pulmonary nodule as identified on CT chest ≤3cm from the pleura will be recruited. A PPN will be defined as a lesion \>10mm and \<3cm in diameter surrounded by lung parenchyma on CT chest. The decision for biopsy of the PPN will be made by the treating physician and agreed upon by the patient.
* Participants must be at least 18 years old or older
* No bleeding disorders
* Provide informed consent.

Exclusion criteria

* less than 18 years
* lack of fitness for flexible bronchoscopy as determined by the physician performing the bronchoscopy before the procedure
* inability to give informed consent

Primary outcomes:
measure: Feasibility
timeFrame: Immediately following procedure
measure: Incidence of Pneumothorax
timeFrame: Immediately after procedure
Secondary outcomes:
measure: Positive Diagnostic Yield of Bronchoscopic Biopsy of Electromagnetic Guidance Trans-thoracic Needle Aspiration (ETTNA) Alone
timeFrame: Approximately 1 week upon receipt of pathology report
measure: Positive Diagnostic Yield of Bronchoscopic Biopsy of ETTNA + EBUS + NB
timeFrame: Approximately 1 week upon receipt of pathology report
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Lonny Yarmus, DO
role: PRINCIPAL_INVESTIGATOR
References: