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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01467635
Other study ID # 2011PA002B
Secondary ID
Status Withdrawn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Status Withdrawn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


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
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