Transbronchial Catheter Aspiration and Transbronchial Needle Aspiration in the Diagnosis of Lung Cancer

NCT ID: NCT00807391

Last Updated: 2011-06-23

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-11-30

Brief Summary

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The aim of this study is prospectively to determine the diagnostic sensitivity of Transbronchial Catheter Aspiration (TBCA) in comparison with Transbronchial Needle Aspiration (TBNA) in the diagnosis of peripheral nodules and masses of the lung.

Detailed Description

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The yield of transbronchial forceps biopsy under fluoroscopy in the diagnosis of peripheral lesion of the lung lies between 32 and 57%. Several studies prove an amelioration of success rates by addition of cytological methods such as TBNA, TBCA and bronchial brushing. Furthermore, for TBNA and TBCA a significantly higher yield was reported in comparison with transbronchial forceps biopsy. TBNA and TBCA are routinely used methods, both techniques are safe, the instruments used are certificated.

Conditions

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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TBCA/TBNA

Under fluoroscopy first transbronchial forceps biopsy is performed, afterwards in random order transbronchial catheter aspiration(TBCA) and transbronchial needle aspiration (TBNA).

Group Type OTHER

TBCA, TBNA

Intervention Type PROCEDURE

One arm, in random order first transbronchial catheter aspiration and second transbronchial needle aspiration or vice verse, both techniques routinely used in the diagnosis of peripheral pulmonary lesions; the cytological specimens of TBCA and TBNA are in random order examined by two independent cytologists, all cytological specimens are afterwards examined by a third, supervising cytologist.

Interventions

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TBCA, TBNA

One arm, in random order first transbronchial catheter aspiration and second transbronchial needle aspiration or vice verse, both techniques routinely used in the diagnosis of peripheral pulmonary lesions; the cytological specimens of TBCA and TBNA are in random order examined by two independent cytologists, all cytological specimens are afterwards examined by a third, supervising cytologist.

Intervention Type PROCEDURE

Other Intervention Names

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transbronchial biopsy

Eligibility Criteria

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Inclusion Criteria

* informed consent prior to the procedure
* radiologically peripheral pulmonary lesions between 10 and 60 millimeters in diameter

Exclusion Criteria

* endoscopically visible lung carcinoma
* no consent in further diagnostic procedures, when bronchoscopy fails to establish a diagnosis
* haemorrhagic syndrome; grave cardiac disease; oxygen saturation lower than 90 percent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helios Klinik Ambrock

OTHER

Sponsor Role lead

Responsible Party

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Helios Klinik Ambrock

Principal Investigators

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Karl-Josef Franke, MD

Role: PRINCIPAL_INVESTIGATOR

Helios Klinik Ambrock

Locations

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Universitätsklinikum Essen, Institut für Pathologie

Essen, North Rhine-Westphalia, Germany

Site Status

Helios Klinik Ambrock, Department of Pneumology and Critical Care Medicine

Hagen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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Franke KJ, Nilius G, Ruhle KH. [Frequency of cytological procedures in diagnostic bronchoscopy of peripheral pulmonary modules and masses]. Pneumologie. 2006 Nov;60(11):663-6. doi: 10.1055/s-2006-944263. German.

Reference Type BACKGROUND
PMID: 17109263 (View on PubMed)

Gasparini S, Ferretti M, Secchi EB, Baldelli S, Zuccatosta L, Gusella P. Integration of transbronchial and percutaneous approach in the diagnosis of peripheral pulmonary nodules or masses. Experience with 1,027 consecutive cases. Chest. 1995 Jul;108(1):131-7. doi: 10.1378/chest.108.1.131.

Reference Type BACKGROUND
PMID: 7606947 (View on PubMed)

Chechani V. Bronchoscopic diagnosis of solitary pulmonary nodules and lung masses in the absence of endobronchial abnormality. Chest. 1996 Mar;109(3):620-5. doi: 10.1378/chest.109.3.620.

Reference Type BACKGROUND
PMID: 8617067 (View on PubMed)

Reichenberger F, Weber J, Tamm M, Bolliger CT, Dalquen P, Perruchoud AP, Soler M. The value of transbronchial needle aspiration in the diagnosis of peripheral pulmonary lesions. Chest. 1999 Sep;116(3):704-8. doi: 10.1378/chest.116.3.704.

Reference Type BACKGROUND
PMID: 10492275 (View on PubMed)

Katis K, Inglesos E, Zachariadis E, Palamidas P, Paraskevopoulos I, Sideris G, Tamvakopoulou E, Apostolopoulou F, Rasidakis A. The role of transbronchial needle aspiration in the diagnosis of peripheral lung masses or nodules. Eur Respir J. 1995 Jun;8(6):963-6.

Reference Type BACKGROUND
PMID: 7589384 (View on PubMed)

Franke KJ, Nilius G, Ruhle KH. Transbronchial catheter aspiration compared to forceps biopsy in the diagnosis of peripheral lung cancer. Eur J Med Res. 2009 Jan 28;14(1):13-7. doi: 10.1186/2047-783x-14-1-13.

Reference Type BACKGROUND
PMID: 19258205 (View on PubMed)

Other Identifiers

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HELIOS 2090

Identifier Type: -

Identifier Source: org_study_id

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