NCT00807391

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Jul 2009

Shorter than P25 for not_applicable lung-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2008

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

June 23, 2011

Status Verified

August 1, 2009

Enrollment Period

1.3 years

First QC Date

December 9, 2008

Last Update Submit

June 22, 2011

Conditions

Lung Cancer

Keywords

lung cancertransbronchial biopsytransbronchial catheter aspirationtransbronchial needle aspirationperipheral pulmonary lesionbronchoscopy

Outcome Measures

Primary Outcomes (1)

  • Diagnostic sensitivity of transbronchial catheter aspiration in comparison with transbronchial needle aspiration.

    one year

Secondary Outcomes (1)

  • Yield by combination of the applied techniques

    one year

Study Arms (1)

TBCA/TBNA

OTHER

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

Procedure: TBCA, TBNA

Interventions

TBCA, TBNAPROCEDURE

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.

Also known as: transbronchial biopsy
TBCA/TBNA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitätsklinikum Essen, Institut für Pathologie

Essen, North Rhine-Westphalia, 45122, Germany

Location

Helios Klinik Ambrock, Department of Pneumology and Critical Care Medicine

Hagen, North Rhine-Westphalia, 58091, Germany

Location

Related Publications (6)

  • 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.

    PMID: 17109263BACKGROUND

  • 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.

    PMID: 7606947BACKGROUND

  • 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.

    PMID: 8617067BACKGROUND

  • 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.

    PMID: 10492275BACKGROUND

  • 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.

    PMID: 7589384BACKGROUND

  • 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.

    PMID: 19258205BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Interventions

chaperonin cofactor A

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Karl-Josef Franke, MD

    Helios Klinik Ambrock

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 9, 2008

First Posted

December 11, 2008

Study Start

July 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

June 23, 2011

Record last verified: 2009-08

Locations

DE(2)