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

NCT ID: NCT00398970

Last Updated: 2008-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2008-01-31

Brief Summary

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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

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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.

Conditions

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Lung Cancer

Keywords

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Endobronchial ultrasonography Fluoroscopy Guide sheath Peripheral pulmonary lesion Transbronchial biopsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Traditional flouroscopy guided sampling

Group Type ACTIVE_COMPARATOR

Endobronchial ultrasound miniprobe

Intervention Type DEVICE

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

Ultrasound guide sampling

Group Type EXPERIMENTAL

Endobronchial ultrasound miniprobe

Intervention Type DEVICE

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

Interventions

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Endobronchial ultrasound miniprobe

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helse Sunnmore, 6026 Ålesund

UNKNOWN

Sponsor Role collaborator

Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Haukeland Univiersity Hospital, Bergen, Norway

Principal Investigators

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Jon A Hardie, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Thoracic Medicine, Haukeland University Hospital

Locations

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Department of Thoracic Medicine

Bergen, , Norway

Site Status

Countries

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Norway

References

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Kikuchi E, Yamazaki K, Sukoh N, Kikuchi J, Asahina H, Imura M, Onodera Y, Kurimoto N, Kinoshita I, Nishimura M. Endobronchial ultrasonography with guide-sheath for peripheral pulmonary lesions. Eur Respir J. 2004 Oct;24(4):533-7. doi: 10.1183/09031936.04.00138603.

Reference Type BACKGROUND
PMID: 15459129 (View on PubMed)

Kurimoto N, Miyazawa T, Okimasa S, Maeda A, Oiwa H, Miyazu Y, Murayama M. Endobronchial ultrasonography using a guide sheath increases the ability to diagnose peripheral pulmonary lesions endoscopically. Chest. 2004 Sep;126(3):959-65. doi: 10.1378/chest.126.3.959.

Reference Type BACKGROUND
PMID: 15364779 (View on PubMed)

Herth FJ, Ernst A, Becker HD. Endobronchial ultrasound-guided transbronchial lung biopsy in solitary pulmonary nodules and peripheral lesions. Eur Respir J. 2002 Oct;20(4):972-4. doi: 10.1183/09031936.02.00032001.

Reference Type BACKGROUND
PMID: 12412691 (View on PubMed)

Schreiber G, McCrory DC. Performance characteristics of different modalities for diagnosis of suspected lung cancer: summary of published evidence. Chest. 2003 Jan;123(1 Suppl):115S-128S. doi: 10.1378/chest.123.1_suppl.115s.

Reference Type BACKGROUND
PMID: 12527571 (View on PubMed)

Baaklini WA, Reinoso MA, Gorin AB, Sharafkaneh A, Manian P. Diagnostic yield of fiberoptic bronchoscopy in evaluating solitary pulmonary nodules. Chest. 2000 Apr;117(4):1049-54. doi: 10.1378/chest.117.4.1049.

Reference Type BACKGROUND
PMID: 10767238 (View on PubMed)

Other Identifiers

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12562

Identifier Type: -

Identifier Source: org_study_id