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EBUS-TBNA vs Flex 19G EBUS-TBNA

Primary Purpose

Lymphadenopathy, Lung Cancer, Sarcoidosis

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
21G EBUS-TBNA needle
Flexible 19G EBUS-TBNA needle
Sponsored by
Heidelberg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lymphadenopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Scheduled for EBUS-TBNA as part of clinical care
  2. Lymph nodes larger than 10mm in diameter
  3. Age > 18 years
  4. written informed consent

Exclusion Criteria:

  1. Contraindication to needle biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia)
  2. Inability to obtain informed consent

Sites / Locations

  • Department of Pneumology and Critical Care medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

EBUS-TBNA

Flex 19G EBUS-TBNA

Arm Description

Mediastinal and hilar lymph node sampling using a standard 21G EBUS-TBNA needle

Mediastinal and hilar lymph node sampling using the flexible 19G EBUS-TBNA needle

Outcomes

Primary Outcome Measures

The difference in quality of diagnostic tissue obtained between the two study arms following 4 separate needle punctures per lymph node
Both specimens (cell pellet and tissue fragments) will be assessed by means of a semiquantitative assessment of material (normal lymph node or lesional tissue) present using the formal scoring system described by Mair

Secondary Outcome Measures

The difference between the two study arms in the percentage of lymph nodes sampled where enough tissue is obtained for complete immunohistochemical and genetic mutation analysis
The difference in complication rates between the two study arms
The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with sarcoidosis
The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with lymphoma
The difference in sensitivity for detecting sarcoidosis between the two study arms
Sensitivity = True Positives/(True Positives + False Negatives)
The difference in sensitivity for detecting lymphoma between the two study arms
Sensitivity = True Positives/(True Positives + False Negatives)

Full Information

First Posted
September 26, 2016
Last Updated
February 6, 2017
Sponsor
Heidelberg University
Collaborators
Olympus Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02916459
Brief Title
EBUS-TBNA vs Flex 19G EBUS-TBNA
Official Title
Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) Versus Flexible 19G Endobronchial Ultrasound Transbronchial Needle (Flex 19G EBUS-TBNA) in the Assessment of Mediastinal and Hilar Lymph-adenopathy: a Randomised Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University
Collaborators
Olympus Corporation

4. Oversight

5. Study Description

Brief Summary
This is a prospective randomised diagnostic clinical study to determine whether the use of a new flexible sampling needle can improve the yield of endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA). Patients undergoing EBUS-TBNA for clinical reasons as deemed necessary by the managing physician or multidisciplinary team will be randomised to undergo either EBUS-TBNA or Flex 19G EBUS-TBNA. The procedure will be performed under local anaesthesia using conscious sedation or general anaesthesia according to usual practice at the trial centre. Specimens will be placed in saline and formalin and forwarded to the pathology laboratory. The specimens will be spun down to create a cell pellet which will undergo cytological and histological examination as per usual protocol at the trial centre.The pathologist, who will be blinded as to which technique was used to obtain the sample, will grade the quality, quantity, and cellularity of the specimens.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphadenopathy, Lung Cancer, Sarcoidosis, Lymphoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EBUS-TBNA
Arm Type
Active Comparator
Arm Description
Mediastinal and hilar lymph node sampling using a standard 21G EBUS-TBNA needle
Arm Title
Flex 19G EBUS-TBNA
Arm Type
Experimental
Arm Description
Mediastinal and hilar lymph node sampling using the flexible 19G EBUS-TBNA needle
Intervention Type
Device
Intervention Name(s)
21G EBUS-TBNA needle
Intervention Type
Device
Intervention Name(s)
Flexible 19G EBUS-TBNA needle
Primary Outcome Measure Information:
Title
The difference in quality of diagnostic tissue obtained between the two study arms following 4 separate needle punctures per lymph node
Description
Both specimens (cell pellet and tissue fragments) will be assessed by means of a semiquantitative assessment of material (normal lymph node or lesional tissue) present using the formal scoring system described by Mair
Time Frame
1 week
Secondary Outcome Measure Information:
Title
The difference between the two study arms in the percentage of lymph nodes sampled where enough tissue is obtained for complete immunohistochemical and genetic mutation analysis
Time Frame
1 week
Title
The difference in complication rates between the two study arms
Time Frame
1 month
Title
The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with sarcoidosis
Time Frame
1 week
Title
The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with lymphoma
Time Frame
1 week
Title
The difference in sensitivity for detecting sarcoidosis between the two study arms
Description
Sensitivity = True Positives/(True Positives + False Negatives)
Time Frame
1 week
Title
The difference in sensitivity for detecting lymphoma between the two study arms
Description
Sensitivity = True Positives/(True Positives + False Negatives)
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Scheduled for EBUS-TBNA as part of clinical care Lymph nodes larger than 10mm in diameter Age > 18 years written informed consent Exclusion Criteria: Contraindication to needle biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia) Inability to obtain informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Felix Herth, Prof. Dr.
Phone
+49-(0)6221-396-1201
Email
herth@uni-heidelberg.de
Facility Information:
Facility Name
Department of Pneumology and Critical Care medicine
City
Heidelberg
State/Province
BW
ZIP/Postal Code
69190
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felix JF Herth, MD, PhD
Phone
+49 6221 396
Ext
1200
Email
felix.herth@thoraxklinik-heidelberg.de
First Name & Middle Initial & Last Name & Degree
Felix JF Herth, MD, Phd
First Name & Middle Initial & Last Name & Degree
Ralf Eberhardt, MD

12. IPD Sharing Statement

Learn more about this trial

EBUS-TBNA vs Flex 19G EBUS-TBNA

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