NCT02916459

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

1.9 years

First QC Date

September 26, 2016

Last Update Submit

February 6, 2017

Conditions

LymphadenopathyLung CancerSarcoidosisLymphoma

Outcome Measures

Primary Outcomes (1)

  • 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

    1 week

Secondary Outcomes (6)

  • 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

    1 week

  • The difference in complication rates between the two study arms

    1 month

  • The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with sarcoidosis

    1 week

  • The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with lymphoma

    1 week

  • The difference in sensitivity for detecting sarcoidosis between the two study arms

    1 week

  • +1 more secondary outcomes

Study Arms (2)

EBUS-TBNA

ACTIVE COMPARATOR

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

Device: 21G EBUS-TBNA needle

Flex 19G EBUS-TBNA

EXPERIMENTAL

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

Device: Flexible 19G EBUS-TBNA needle

Interventions

21G EBUS-TBNA needleDEVICE
EBUS-TBNA
Flexible 19G EBUS-TBNA needleDEVICE
Flex 19G EBUS-TBNA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for EBUS-TBNA as part of clinical care
  • Lymph nodes larger than 10mm in diameter
  • Age \> 18 years
  • written informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pneumology and Critical Care medicine

Heidelberg, Baden-Wurttemberg, 69190, Germany

RECRUITING

MeSH Terms

Conditions

LymphadenopathyLung NeoplasmsSarcoidosisLymphoma

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesLymphoproliferative DisordersHypersensitivity, DelayedHypersensitivityImmune System DiseasesNeoplasms by Histologic TypeImmunoproliferative Disorders

Central Study Contacts

Felix Herth, Prof. Dr.

CONTACT

+49-(0)6221-396-1201herth@uni-heidelberg.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

September 26, 2016

First Posted

September 27, 2016

Study Start

October 1, 2016

Primary Completion

September 1, 2018

Study Completion

October 1, 2018

Last Updated

February 7, 2017

Record last verified: 2017-02

Locations

DE(1)