Rapid On-site Cytopathologic Evaluation in the Diagnosis of Hilar/Mediastinal Adenopathy

February 18, 2010 updated by: Maggiore Bellaria Hospital, Bologna

Transbronchial Needle Aspiration With and Without Rapid On-site Cytopathologic Evaluation in the Diagnostic Approach to Hilar/Mediastinal Adenopathy: A Randomized Controlled Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40133
        • Maggiore Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Uncontrolled coagulopathy
  • Refusal to sign informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TBNA alone
Arm A: TBNA alone.
Procedure: TBNA
transbronchial needle aspiration
Experimental: TBNA with ROSE
Arm B: TBNA with ROSE.
Procedure: TBNA
transbronchial needle aspiration
Procedure: Rapid on-site cytopathologic evaluation (ROSE)
ROSE: examination in the endoscopy suite, by a pathologist, during the bronchoscopic procedure, of samples obtained with transbronchial needle aspiration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Examine the diagnostic yield of the TBNA with ROSE arm versus the diagnostic yield of TBNA alone arm
Time Frame: 6-12 months
6-12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Examine the percentage of inadequate samples in the TBNA with ROSE arm versus the TBNA alone arm
Time Frame: 6-12 months
6-12 months
Examine the number of biopsy sites in the TBNA with ROSE arm versus the TBNA alone arm
Time Frame: 6-12 months
6-12 months
Examine the complication rate of bronchoscopy in the TBNA with ROSE arm versus the TBNA alone arm
Time Frame: 6-12 months
6-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maggiore Bellaria Hospital, Bologna

Investigators

  • Principal Investigator: Marco Patelli, MD, Maggiore Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

June 4, 2009

First Submitted That Met QC Criteria

June 5, 2009

First Posted (Estimate)

June 8, 2009

Study Record Updates

Last Update Posted (Estimate)

February 19, 2010

Last Update Submitted That Met QC Criteria

February 18, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-Trisolini

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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