NCT00915330

Brief Summary

The purpose of this study is to determine whether rapid on-site cytopathologic evaluation (ROSE) can increase the diagnostic yield of transbronchial needle aspiration (TBNA) in the diagnosis of hilar and mediastinal lymphadenopathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
Completed

Started May 2009

Shorter than P25 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 4, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 8, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

February 19, 2010

Status Verified

February 1, 2010

Enrollment Period

9 months

First QC Date

June 4, 2009

Last Update Submit

February 18, 2010

Conditions

Lung CancerSarcoidosisTuberculosis

Keywords

Transbronchial needle aspirationBronchoscopyRapid on-site cytopathologic evaluationMediastinal lymphadenopathyHilar Lymphadenopathy

Outcome Measures

Primary Outcomes (1)

  • Examine the diagnostic yield of the TBNA with ROSE arm versus the diagnostic yield of TBNA alone arm

    6-12 months

Secondary Outcomes (3)

  • Examine the percentage of inadequate samples in the TBNA with ROSE arm versus the TBNA alone arm

    6-12 months

  • Examine the number of biopsy sites in the TBNA with ROSE arm versus the TBNA alone arm

    6-12 months

  • Examine the complication rate of bronchoscopy in the TBNA with ROSE arm versus the TBNA alone arm

    6-12 months

Study Arms (2)

TBNA alone

ACTIVE COMPARATOR

Arm A: TBNA alone.

Procedure: TBNA

TBNA with ROSE

EXPERIMENTAL

Arm B: TBNA with ROSE.

Procedure: Rapid on-site cytopathologic evaluation (ROSE)Procedure: TBNA

Interventions

Rapid on-site cytopathologic evaluation (ROSE)PROCEDURE

ROSE: examination in the endoscopy suite, by a pathologist, during the bronchoscopic procedure, of samples obtained with transbronchial needle aspiration.

TBNA with ROSE
TBNAPROCEDURE

transbronchial needle aspiration

TBNA aloneTBNA with ROSE

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old and older
  • Hilar and/or mediastinal lymphadenopathy (\> 1 cm on the short axis, as assessed by contrast-enhanced CT scan (computed tomography))

You may not qualify if:

  • Uncontrolled coagulopathy
  • Refusal to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maggiore Hospital

Bologna, 40133, Italy

Location

Related Publications (5)

  • Diacon AH, Schuurmans MM, Theron J, Louw M, Wright CA, Brundyn K, Bolliger CT. Utility of rapid on-site evaluation of transbronchial needle aspirates. Respiration. 2005 Mar-Apr;72(2):182-8. doi: 10.1159/000084050.

    PMID: 15824529RESULT

  • Davenport RD. Rapid on-site evaluation of transbronchial aspirates. Chest. 1990 Jul;98(1):59-61. doi: 10.1378/chest.98.1.59.

    PMID: 2361413RESULT

  • Baram D, Garcia RB, Richman PS. Impact of rapid on-site cytologic evaluation during transbronchial needle aspiration. Chest. 2005 Aug;128(2):869-75. doi: 10.1378/chest.128.2.869.

    PMID: 16100180RESULT

  • Diette GB, White P Jr, Terry P, Jenckes M, Rosenthal D, Rubin HR. Utility of on-site cytopathology assessment for bronchoscopic evaluation of lung masses and adenopathy. Chest. 2000 Apr;117(4):1186-90. doi: 10.1378/chest.117.4.1186.

    PMID: 10767258RESULT

  • Trisolini R, Cancellieri A, Tinelli C, Paioli D, Scudeller L, Casadei GP, Forti Parri S, Livi V, Bondi A, Boaron M, Patelli M. Rapid on-site evaluation of transbronchial aspirates in the diagnosis of hilar and mediastinal adenopathy: a randomized trial. Chest. 2011 Feb;139(2):395-401. doi: 10.1378/chest.10-1521. Epub 2010 Oct 28.

    PMID: 21030491DERIVED

MeSH Terms

Conditions

Lung NeoplasmsSarcoidosisTuberculosis

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Marco Patelli, MD

    Maggiore Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 4, 2009

First Posted

June 8, 2009

Study Start

May 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

February 19, 2010

Record last verified: 2010-02

Locations

IT(1)