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NCT Number: NCT00925210

Bronchoscopic Approach to the Peripheral Lung Nodule - An Alternative Approach

Patients presenting with solitary or multiple lung nodules often require tissue confirmation in order to guide further management and determine if the lesion is benign or malignant. Several bronchoscopic techniques have emerged which have significantly improved the diagnostic yield of bronchoscopy in this setting, and in particular the combination of peripheral Endobronchial Ultrasonography (pEBUS) and Electromagnetic Navigation Bronchoscopy (ENB) has resulted in diagnostic yields of nearly 90%. In an attempt to reduce the significant cost of this combined approach, the sequential use of pEBUS followed by the more costly ENB technique only if a lesion is not identified on the ultrasound image could be as accurate. This study aims to determine the diagnostic yield of this sequential approach in patients with lung nodule(s).

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Key information

Conditions

Solitary Pulmonary Nodule Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Foothills Medical Center, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >16 years
  • Lung nodule (s) identified on CT scan
  • Clinical decision to obtain tissue biopsy of lung lesion
  • CT guided biopsy not preferred technique (previous negative CT guided biopsy or technically difficult nodule location or perceived high risk of pneumothorax or other complications)
  • Pleural based lesion only if: Inaccessible by CT guided biopsy or previous CT guided biopsy non-diagnostic

Exclusion criteria

  • Lack of informed consent
  • Nodule less than 1 cm or greater than 6 cm long axis
  • Mediastinal adenopathy >2cm short axis on CT chest
  • Evidence of endobronchial abnormality on chest CT
  • Medical contraindication to bronchoscopy
  • Patients with lesions highly suspicious for lung cancer, potentially resectable with lobar or lesser resection and without significantly increased operative risk factors will not be entered into this study prior to surgical evaluation.
  • Patient with implanted electronic medical device
  • Uncontrolled or irreversible coagulopathy (platelets <100, INR >1.3, use of clopidogrel in the 7 days prior to bronchoscopy)
  • Confirmed or suspected pregnancy

Treatment and study plan

Sequential pEBUS - ENB

Procedure

Subject will undergo bronchoscopy with peripheral endobronchial ultrasonography to identify the peripheral lung nodule. If the lesion is identified with pEBUS, samples will be collected.

If the lesion is not found by pEBUS, the electromagnetic navigation system will be deployed and directed to the lesion of interest, once again using pEBUS to confirm final location before samples are collected.

Primary outcomes

  1. diagnostic yield

Secondary outcomes

  1. sensitivity, specificity, positive and negative predictive value

  2. Impact of nodule size (<2 cm, 2-3 cm, >3cm) and distribution on diagnostic yield

  3. Independent and incremental yield of BAL, biopsy, needle aspiration and brush cytology will be compared

  4. Complication rate

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

Bronchoscopic Approach to the Peripheral Lung Nodule - An Alternative Approach Using Peripheral Endobronchial Ultrasonography and Electromagnetic Navigation Bronchoscopy

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 22, 2009
Registry last updated
Sep 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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