EBUS-TBNA Versus EBUS-TBNB

Lymphoma Clinical Trial

Official title:

Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) Versus Endobronchial Ultrasound Transbronchial Needle Biopsy (EBUS-TBNB) in the Assessment of Mediastinal and Hilar Lymphadenopathy: a Randomised Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01467635
• Other study ID #: 2011PA002B
• Status: Withdrawn
• Phase: N/A
• First received: November 4, 2011
• Last updated: July 12, 2016
• Start date: May 2014
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

A prospective diagnostic clinical study randomising patients undergoing endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of enlarged mediastinal and hilar lymph nodes to have sampling using the usual EBUS-TBNA needle or a novel biopsy forceps (EBUS-TBNB).

The study aims to establish whether the use of EBUS-TBNB can significantly increase the diagnostic yield over EBUS-TBNA, without an increase in complication rates.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Scheduled for EBUS-TBNA as part of clinical care

• Lymph nodes larger than 10mm in diameter

• Age > 18 years

• Able to provide written informed consent

Exclusion Criteria:

• Contraindications for needle or forceps biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia)

• Inability to obtain informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma
• Hilar Lymphadenopathy
• Lymphoma
• Mediastinal Lymphadenopathy
• Mycobacterial Disease
• Mycobacterium Infections
• Sarcoidosis

Intervention

Device:
• Endobronchial ultrasound guided lymph node sampling
Patients with enlarged mediastinal or hilar lymph nodes have these sampled under endobronchial ultrasound guidance using either the EBUS-TBNA needle or the EBUS-TBNB biopsy forceps.

Locations

Country	Name	City	State
Germany	Thoraxklinik, University of Heidelberg	Heidelberg
United Kingdom	Chelsea and Westminster Hospital	London
United Kingdom	The Royal Brompton Hospital	London

Sponsors (3)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust	Chelsea and Westminster NHS Foundation Trust, Heidelberg University

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of lymph nodes sampled resulting in a definitive diagnosis (as defined in the protocol) in the two study arms.	The definition of a "definitive diagnosis" is dependant on the diagnosis and is clarified below: Carcinoma/lymphoma: The lymph node sample is adequate to make a diagnosis as well as provide immunohistochemistry information enabling subtyping of the tumour.; Sarcoidosis: The presence of well formed epithelioid non-caseating granulomas.; Mycobacterial infection: The presence of caseating granulomas, positive Ziehl Nielson staining for acid fast bacilli, or the tissue successfully cultures Mycobacterium.	18 months	No
Secondary	The difference in the complication rate between the two study arms		24 months	Yes