N/A
Completed N=258
Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration
Lung Nodule
Source: ClinicalTrials.gov NCT04250194 ↗
Enrolled (actual)
258
Serious AEs
6.8%
Results posted
Jul 2025
Primary outcomePrimary: Diagnostic Accuracy — 94; 81 Participants — p=0.003
Summary
This study will evaluate which procedure is the best for patients referred for biopsy of a lung nodule (growth in the lung) meeting the size and location requirements of the protocol. Two different procedures are available for lung nodule biopsy:
1. a computed tomography guided biopsy ("CT-guided biopsy") which consists of sampling the nodule from the "outside-in", through the chest wall with CT guidance, and
2. navigation bronchoscopy, which is a procedure using technology designed to guide a catheter through the natural airway route (wind-pipe and bronchi) to access the nodule.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diagnostic Accuracy |
94; 81 | 0.003 sig |
| SECONDARY Diagnostic Yield |
96; 88 | — |
| SECONDARY Rate of Pneumothorax |
4; 32 | — |
| SECONDARY Rate of Pneumothorax Requiring Chest Tube Placement |
1; 9 | — |
| SECONDARY Need for Hospitalization After Procedure |
1; 13 | — |
| SECONDARY Duration of Procedure |
36; 24.5 | — |
| SECONDARY Procedural Factors Associated With Improved Yield (Type of Biopsy) |
116; 93; 23; 76; 64; 12 | — |
| SECONDARY Procedural Factors Associated With Improved Yield (Number of Biopsies) |
8.0; 8.0; 8.0; 5.0; 5.0; 5.0 | — |
| SECONDARY Procedural Factors Associated With Improved Yield (Use of Radial Ultrasound) |
20; 20; 0; 39; 30; 9 | — |
| SECONDARY Procedural Factors Associated With Improved Yield (Presence of a Bronchus Sign) |
37; 30; 59; 58 | — |
| SECONDARY Procedural Factors Associated With Improved Yield (Biopsy Site) |
86; 77; 10; 11 | — |
| SECONDARY Need for Additional Nodule Biopsy |
16; 15 | — |
| SECONDARY Need for Additional Procedure for Staging |
0; 3 | — |
| SECONDARY Radiation Exposure From Fluoroscopy-guided Bronchoscopy |
9800 | — |
| SECONDARY Need for F-Nav During Navigation Bronchoscopy |
96; 71; 25 | — |
| SECONDARY Confident Clinical Diagnosis |
96; 88 | — |
| SECONDARY Radiation Exposure From CT for CT-guided Biopsy |
659 | — |
| SECONDARY Procedural Factors Associated With Improved Yield (Type of Biopsy): CT-guided Group |
6; 4; 2; 75; 64; 11 | — |
Eligibility Criteria
Inclusion Criteria
- Patient is referred for biopsy of a single indeterminate pulmonary nodule, with the following characteristics regarding size, location, accessibility, and probability of malignancy:
- Intermediate pre-test probability of malignancy as defined by a pre-test probability of malignancy between 10% and 100%, using a validated clinical prediction model, which is either:
- The Brock model14 if no PET scan data are available, or
- The Herder model15 if PET-CT data are available.
- Size between 10 and 30 mm (long diameter).
- Location peripheral, here defined as occupying the middle or outer third lung zones.
- Accessible via navigation bronchoscopy and also accessible via CT-guided biopsy (i.e. the nodule is clinically suited to equal access by either procedure), as confirmed by an independent interventional panel.
Exclusion Criteria
- Patients with proximal nodules, as defined by nodules present in the proximal 1/3 of the lung by dedicated software analysis (described below) will not be eligible for the study.
- Patients with multiple nodules requiring biopsy (patients may have other nodules not considered for biopsy).
Data sourced from ClinicalTrials.gov (NCT04250194). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.