Comparison of 22-gauge and 19-gauge Aspiration Needle During EBUS-TBNA

Lung Cancer Clinical Trial

Official title:

Comparison of the Diagnostic Yield Between Various Endobronchial Ultrasound-guided-transbronchial Needles (EBUS-TBN) to Evaluate Suspect Mediastinal and Hilar Lymph Nodes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02813603
• Other study ID #: EBUS19VS22
• Status: Completed
• Start date: May 2016
• Est. completion date: March 2018

Study information

• Verified date: July 2018
• Source: University Hospital, Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Investigators intend to compare the 19-gauge needle and the 22-gauge-needle during EBUS-TBNA concerning the diagnostic yield, the quality and quantity of each biopsy needle without raising the rate of complications.

Description:

Investigators intend to compare the 19-gauge needle and the 22-gauge-needle during EBUS-TBNA performed in rigid bronchoscopy for patients with probable lung cancer diagnosis and enlarged mediastinal lymph nodes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female patients aged over 18

• Patients signed written informed consent

• Mediastinal or hilar enlarged lymph nodes (>10mm) in short axis radiological or clinical findings likely for lung cancer

Exclusion Criteria:

• Severe impairment of any organs, with do not enable anaesthesia

• Quick <80%, INR >1,5, thrombocytes <50/nl or PTT>120sec

• Other clinically relevant medical or psychological diseases, which affect the patients judgement or ability to participate in this study.

• Insufficient language ability (spoken and written German)

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Procedure:
• EBUS
19G and 22G EBUS needles are compared in a randomized prospective way in lung cancer patients with enlarged mediastinal lymph nodes.

Locations

Country	Name	City	State
Germany	Ruhrlandklinik, University Hospital Essen	Essen	NRW
Switzerland	University Hospital Zürich	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Essen	University Hospital, Zürich

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sample weight		February 2017
Secondary	The number of complications like bleeding, infections, pneumothorax and pain		February 2017