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.

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Device: Endobronchial ultrasound miniprobe

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.

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Department of Thoracic Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diagnostic yield of bronchoscopy	6 months

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: Helse Sunnmore, 6026 Ålesund
• Investigators: Principal Investigator: Jon A Hardie, MD/PhD, Department of Thoracic Medicine, Haukeland University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: November 13, 2006
• First Submitted That Met QC Criteria: November 13, 2006
• First Posted (Estimate): November 14, 2006

Study Record Updates

• Last Update Posted (Estimate): February 29, 2008
• Last Update Submitted That Met QC Criteria: February 25, 2008
• Last Verified: February 1, 2008

More Information

Terms related to this study

• Keywords: Fluoroscopy; Transbronchial biopsy; Peripheral pulmonary lesion; Endobronchial ultrasonography; Guide sheath
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 12562