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

NCT01658280 | Completed Phase 4

• 1 other identifier: PAN-001
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

transbronchial needle aspiration; ultrasound guided transbronchial needle aspiration; sensitivity; hilar/mediastinal adenopathy

Outcome Measures

Primary Outcomes (1)

• To compare the sensitivity of EBUS-TBNA and conventional TBNA in the diagnosis of hilar/mediastinal adenopathies

  The sensitivity is defined as the rate of true positive diagnoses/(true positive + false negative). Sensitivity of EBUS-TBNA will be considered superior to that of conventional TBNA if it will achieve at least a value of 90%

  36 months

Secondary Outcomes (5)

• Specificity of TBNA and EBUS-TBNA

  36 months

• Sensitivity of EBUS-TBNA performed after the possible failure of traditional TBNA

  36 months

• Number of partecipants with adverse events

  36 months

• Costs related to each diagnostic strategy

  36 months

• Procedural time

  36 months

Study Arms (2)

Conventional TBNA + ROSE

ACTIVE COMPARATOR

Patients allocated in this group will undergo conventional TBNA, performed in a bronchoscopy suite by the same operator under conscious sedation, using 19-G needle size. Three needle passes for each approachable station will be performed. The samples obtained will be examined on-site by experienced blinded cytopathologist. In case of samples obtained from conventional TBNA defined as "non diagnostic", the operator will shift to the EBUS procedure.All specimens obtained will be send to definitive cytological and histological evaluation and the final diagnosis will be collected and reported on CRFs

Device: EBUS-TBNA

EBUS-TBNA + ROSE

EXPERIMENTAL

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

Device: EBUS-TBNA

Interventions

EBUS-TBNA DEVICE

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

Conventional TBNA + ROSE; EBUS-TBNA + ROSE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18years;
• presence of at least one hilar/mediastinal adenopathy \>1 cm on short axis assessed by contrast-enhanced CT scan in at least one approachable stations other than 2R and 2L;
• ability to give an informed consent.

You may not qualify if:

• presence of mediastinal adenopathy in stations 2R and 2L;
• coagulopathy or bleeding diathesis that cannot be corrected;
• severe refractory hypoxemia;
• unstable hemodynamic status;
• inability to give an informed consent.

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Ospedali Riuniti: lead

Study Sites (1)

Pulmonary Diseases Unit, Department of Immunoallergic and Respiratory Diseases, Azienda Ospedaliero Universitaria 'Ospedali Riuniti'

Ancona, The Marches, 60100, Italy

Location

Related Publications (3)

• Herth F, Becker HD, Ernst A. Conventional vs endobronchial ultrasound-guided transbronchial needle aspiration: a randomized trial. Chest. 2004 Jan;125(1):322-5. doi: 10.1378/chest.125.1.322.

  PMID: 14718460 BACKGROUND

• Gasparini S. It is time for this 'ROSE' to flower. Respiration. 2005 Mar-Apr;72(2):129-31. doi: 10.1159/000084041. No abstract available.

  PMID: 15824520 BACKGROUND

• Toloza EM, Harpole L, Detterbeck F, McCrory DC. Invasive staging of non-small cell lung cancer: a review of the current evidence. Chest. 2003 Jan;123(1 Suppl):157S-166S. doi: 10.1378/chest.123.1_suppl.157s.

  PMID: 12527575 BACKGROUND

MeSH Terms

Conditions

Lymphoma; Lung Neoplasms; Sarcoidosis; Hypersensitivity

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Hypersensitivity, Delayed

Study Officials

• Stefano Gasparini, Professor

  Azienda Ospedaliero, Universitaria Ospedali Riuniti

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 1, 2012
• First Posted: August 7, 2012
• Study Start: August 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: July 1, 2015
• Last Updated: February 3, 2016

Record last verified: 2016-02

Locations

IT (1)