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

Diagnostic Utility of Endobronchial Ultrasound in the Investigation of Suspected Malignant Lung Lesions Where the Lesions Are Not Visible During Bronchoscopy.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00398970
Enrollment
240
Registered
2006-11-14
Start date
2005-06-30
Completion date
2008-01-31
Last updated
2008-02-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

Endobronchial ultrasonography, Fluoroscopy, Guide sheath, Peripheral pulmonary lesion, Transbronchial biopsy

Brief summary

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.

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.

Interventions

DEVICEEndobronchial ultrasound miniprobe

Endobronchial ultrasound miniprobe is used to identify solid mass in lung parenchyma.

Sponsors

Helse Sunnmore, 6026 Ålesund
CollaboratorUNKNOWN
Haukeland University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Diagnostic yield of bronchoscopy6 months

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026