Bronchoscopic Sampling Techniques in Sarcoidosis

Tuberculosis Clinical Trial

Official title:

Diagnostic Accuracy of Different Bronchoscopic Sampling Techniques in Patients With Mediastinal Lymph Node Enlargement Suspected of Sarcoidosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01836822
• Other study ID #: IPU-DIMPA-WUM13(1)
• Status: Recruiting
• Phase: N/A
• First received: April 17, 2013
• Last updated: February 11, 2014
• Start date: March 2013
• Est. completion date: May 2014

Study information

• Verified date: February 2014
• Source: Medical University of Warsaw
• Contact: Rafal Krenke, MD, PhD
• Email: rafalkrenke[@]interia.pl
• Is FDA regulated: No
• Health authority: Poland: Bioethics Appeals Commission
• Study type: Interventional

Clinical Trial Summary

The development of endobronchial ultrasound (EBUS) and EBUS-guided transbronchial needle aspiration (EBUS-TBNA) has improved the safety and diagnostic accuracy of the mediastinal lymph node (MLN) sampling. Still, in some diseases routine cytological specimens are considered insufficient and histological sampling is preferred. The aim of the study is to compare the diagnostic accuracy of EBUS-TBNA and two other, more invasive procedures to obtain histological samples from MLN in patients with clinical and radiological features of sarcoidosis.

Bronchoscopy with bronchoalveolar lavage (BAL), EBUS-TBNA, EBUS guided transbronchial forceps biopsy (EBUS-TBFB), large bore (19G) histology TBNA as well as endobronchial forceps biopsy will be performed in 90 consecutive patients with mediastinal lymph node enlargement and clinical and radiological features of sarcoidosis.

Diagnostic accuracy of each sampling technique will be calculated and compared to other techniques. Diagnostic yield of different technique combinations will also be calculated and the most efficient diagnostic approach will be defined.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• provided informed consent

• mediastinal lymph node enlargement that requires bronchoscopy and transbronchial sampling

• clinical presentation that might be consistent with sarcoidosis

Exclusion Criteria:

• age below 18 years

• known contraindications for bronchoscopy and/or mediastinal sampling, e.g. coagulation disorders

• lung or extrapulmonary tumors with suspicion of malignant mediastinal lymph node involvement

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hypertrophy
• Lymphatic Diseases
• Lymphomas
• Mediastinal Lymph Node Enlargement
• Sarcoidosis
• Tuberculosis

Intervention

Procedure:
• EBUS guided transbronchial forceps biopsy (EBUS-TBFB)

• EBUS guided transbronchial needle aspiration (EBUS-TBNA)

• large bore (19G) histologic needle biopsy of the mediastinal lymph nodes

• Bronchoalveolar lavage (BAL)

• Endobronchial forceps biopsy

Locations

Country	Name	City	State
Poland	Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Local complications of mediastinal lymph node sampling	The number of patients in whom mediastinal vessels would be injured (resulting in endobronchial or extrabronchial bleeding). The number of patients with pneumothorax and/or pneumomediastinum complicating mediastinal sampling	During and 24 hrs after bronchoscopic procedure	Yes
Primary	Accuracy of different bronchoscopic sampling methods in making the diagnosis of sarcoidosis.	Comparison of the diagnostic yield of the cytologic and histologic specimens collected by EBUS-TBNA, EBUS-TBFB, large bore TBNA, endobronchial forceps biopsy and BAL in terms of making the diagnosis of sarcoidosis.	Approximately ten days after the procedure, when the results of the cytological and histopathological examination will be available	No
Secondary	Adequacy of cytologic and histopathologic specimens collected by different sampling method as the diagnostic samples enabling confirmation of granulomatous lymph node disease.	Comparison of the number of patients in whom the specific sampling method has been undertaken (e.g. BAL, EBUS-TBNA, EBUS-TBFB and large bore TBNA) with the number of patients in whom the specific sampling method provided the adequate specimens, containing the elements of granulomas (also the relationship between the mediastinal lymph node dimension and the quality of the samples collected with different techniques)	up to 9 months	No