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Conventional Versus Ultrasound-guided Transbronchial Needle Aspiration for the Diagnosis of Hilar/Mediastinal Lymphadenopathies

NCT01658280 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2016-02-03

No results posted yet for this study

Summary

The main purpose of the present study is to assess whether the sensitivity of Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) is superior to that of conventional TBNA in the diagnosis of hilar/mediastinal adenopathy and lung cancer staging.

Conditions

  • Mediastinal Lymphadenopathy
  • Hilar Lymphadenopathy
  • Lymphoma
  • Lung Neoplasms
  • Sarcoidosis

Interventions

DEVICE

EBUS-TBNA

Patients allocated in the intervention group will undergo EBUS-TBNA procedure, performed in a bronchoscopy suite by the same operator under conscious sedation Three needle passes for each approachable station will be performed. The samples obtained will be examined on-site by experienced blinded cytopathologist.All specimens obtained will be send to definitive cytological and histological evaluation and the final diagnosis will be collected and reported on CRFs

Sponsors & Collaborators

  • Azienda Ospedaliero, Universitaria Ospedali Riuniti

    lead OTHER

Principal Investigators

  • Stefano Gasparini, Professor · Azienda Ospedaliero, Universitaria Ospedali Riuniti

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-05-31
Completion
2015-07-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01658280 on ClinicalTrials.gov