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Utility of Endobronchial Ultrasound in the Investigation of Suspected Lung Cancer.

This study has been completed.
Sponsor:
Collaborator:
Helse Sunnmore, 6026 Ålesund
Information provided by:
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT00398970
First received: November 13, 2006
Last updated: February 25, 2008
Last verified: February 2008
  Purpose

Bronchoscopy of non visible lesions in the lung, have a low diagnostic yield. The use of endoscopic ultrasound might increase the diagnostic yield. This prospective study randomises between bronchoscopy with the use of a ultrasound miniprobe and bronchoscopy without the use of a miniprobe in clinical practice at Haukeland University Hospital.

The study hypothesis:

The use of the ultrasound miniprobe will increase the diagnostic yield of bronchoscopy in non visible lesions.


Condition Intervention
Lung Cancer
Device: Endobronchial ultrasound miniprobe

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Diagnostic Utility of Endobronchial Ultrasound in the Investigation of Suspected Malignant Lung Lesions Where the Lesions Are Not Visible During Bronchoscopy.

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Diagnostic yield of bronchoscopy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: June 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Traditional flouroscopy guided sampling Device: Endobronchial ultrasound miniprobe
Endobronchial ultrasound miniprobe is used to identify solid mass in lung parenchyma.
Experimental: Ultrasound guide sampling Device: Endobronchial ultrasound miniprobe
Endobronchial ultrasound miniprobe is used to identify solid mass in lung parenchyma.

Detailed Description:

Bronchoscopy is usually the primary investigation of lesions in the lung. X-ray fluorescence guides the sampling with brushing, biopsy or trans bronchial needle aspiration (TBNA) if the lesion not is visible. Ct guided trans-thoracic sampling will be performed if a the sample is non representative. This will delay the diagnosis, and trans-thoracic sampling has a higher risk of pneumothorax. The use of a ultrasound miniprobe might increase the diagnostic yield of bronchoscopy in non visible lesions. The ultrasound probe in a guide sheath is advanced to the lesion with use of X-ray fluorescence. When the lesion is visualised the miniprobe is removed and sampling is performed with TBNA, biopsy and brushing through the guide sheath. If rapid on site cytoevaluation is negative, new TBNA is performed. Previous trials have shown a diagnostic yield without ultrasound between 40-50% and with ultrasound between 60-80%. The studies with ultrasound have been performed by "super specialists". This study will evaluate bronchoscopy with the use of ultrasound miniprobe in clinical practice without "super specialists". It is a prospective randomised trial.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients with lesions suspicious of malignancy in the lung.

Exclusion Criteria:

  • Patients with lesions assumed to be visible by bronchoscopy.
  • Later proven visible lesion by bronchoscopy.
  • Patients not able to be investigated by bronchoscopy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398970

Locations
Norway
Department of Thoracic Medicine
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
Helse Sunnmore, 6026 Ålesund
Investigators
Principal Investigator: Jon A Hardie, MD/PhD Department of Thoracic Medicine, Haukeland University Hospital
  More Information

Publications:
Responsible Party: Jon Andrew Hardie, MD/PhD, Haukeland Univiersity Hospital, Bergen, Norway
ClinicalTrials.gov Identifier: NCT00398970     History of Changes
Other Study ID Numbers: 12562
Study First Received: November 13, 2006
Last Updated: February 25, 2008
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Haukeland University Hospital:
Endobronchial ultrasonography
Fluoroscopy
Guide sheath
Peripheral pulmonary lesion
Transbronchial biopsy

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014