EBUS-TBNA vs Flex 19G EBUS-TBNA

NCT ID: NCT02916459

Last Updated: 2017-02-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-10-31

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.

Conditions

Lymphadenopathy; Lung Cancer; Sarcoidosis; Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

EBUS-TBNA

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

Group Type: ACTIVE_COMPARATOR

21G EBUS-TBNA needle

Intervention Type: DEVICE

Flex 19G EBUS-TBNA

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

Group Type: EXPERIMENTAL

Flexible 19G EBUS-TBNA needle

Intervention Type: DEVICE

Interventions

21G EBUS-TBNA needle

Intervention Type: DEVICE

Flexible 19G EBUS-TBNA needle

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heidelberg University

OTHER

Sponsor Role: lead

Olympus Corporation

INDUSTRY

Sponsor Role: collaborator

Responsible Party

Felix JF Herth

Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Pneumology and Critical Care medicine

Heidelberg, Baden-Wurttemberg, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Felix Herth, Prof. Dr.

Role: CONTACT

herth@uni-heidelberg.de

+49-(0)6221-396-1201

Facility Contacts

Felix JF Herth, MD, PhD

Role: primary

felix.herth@thoraxklinik-heidelberg.de

+49 6221 396 ext. 1200

Other Identifiers

19G 1.1-2016

Identifier Type: -

Identifier Source: org_study_id