Lymphoma Clinical Trial
Official title:
Conventional Versus Ultrasound-guided Transbronchial Needle Aspiration, Using Rapid On-site Cytological Evaluation, for the Diagnosis of Hilar/Mediastinal Enlarged Lymph Nodes: a Randomized Controlled Trial.
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.
Status | Completed |
Enrollment | 253 |
Est. completion date | July 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Italy | Pulmonary Diseases Unit, Department of Immunoallergic and Respiratory Diseases, Azienda Ospedaliero Universitaria 'Ospedali Riuniti' | Ancona | Marche |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero, Universitaria Ospedali Riuniti |
Italy,
Gasparini S. It is time for this 'ROSE' to flower. Respiration. 2005 Mar-Apr;72(2):129-31. — View Citation
Herth F, Becker HD, Ernst A. Conventional vs endobronchial ultrasound-guided transbronchial needle aspiration: a randomized trial. Chest. 2004 Jan;125(1):322-5. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Specificity of TBNA and EBUS-TBNA | Specificity is defined as the rate of true negatives diagnoses /true negative + false positive | 36 months | No |
Secondary | Sensitivity of EBUS-TBNA performed after the possible failure of traditional TBNA | 36 months | No | |
Secondary | Number of partecipants with adverse events | 36 months | Yes | |
Secondary | Costs related to each diagnostic strategy | It will be evaluated the cost related to the whole procedure, including the possible shift to EBUS-TBNA. | 36 months | No |
Secondary | Procedural time | 36 months | No |
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