Bronchial Ultrasonography Via a Fibrescope: Pilot Study in Tumoral Disease

Pulmonary Neoplasms Clinical Trial

Official title:

Bronchial Ultrasonography Via a Fibrescope: Pilot Study in Tumoral Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00241267
• Other study ID #: CT04-FT/ENDO
• Status: Terminated
• Phase: N/A
• First received: October 14, 2005
• Last updated: October 5, 2006
• Start date: March 2005
• Est. completion date: March 2006

Study information

• Verified date: May 2006
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

The exploration of neoplastic pulmonary pathology is based on computed tomography and bronchoscopy. This allows targeted samples of the identified lesions.

A new ultrasonographic method is proposed as a non invasive and non irradiating technic by using a dedicated probe easily introduced via the channel of the fibrescope, so as to complete the identification of peripheral lesions.

Description:

The main objective of the study is to assess the ability of endobronchial ultrasonography to diagnose peripheral pulmonary lesions during the bronchoscopy and to correlate the abnormalities to computed tomography and/or histology.

The dedicated probe consist of a linear array of 2-3 mm in diameter connected to a commercial unit.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Assumed proximal neoplastic pulmonary pathology

• Planned bronchoscopy and biopsy

Exclusion Criteria:

• Pregnancy

• Breastfeeding

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Lung Neoplasms
• Pulmonary Neoplasms

Intervention

Device:
• Dedicated ultrasonographic probe during bronchoscopy

Locations

Country	Name	City	State
France	University Hospital of TOURS	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

References & Publications (3)

Baba M, Sekine Y, Suzuki M, Yoshida S, Shibuya K, Iizasa T, Saitoh Y, Onuma EK, Ohwada H, Fujisawa T. Correlation between endobronchial ultrasonography (EBUS) images and histologic findings in normal and tumor-invaded bronchial wall. Lung Cancer. 2002 Jan — View Citation

Falcone F, Fois F, Grosso D. Endobronchial ultrasound. Respiration. 2003 Mar-Apr;70(2):179-94. Review. — View Citation

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. — View Citation