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

NCT02813603 | Completed

• 1 other identifier: EBUS19VS22
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Lung Cancer

Keywords

EBUS-TBNA; staging; lymph node metastases

Outcome Measures

Primary Outcomes (1)

• sample weight

  February 2017

Secondary Outcomes (1)

• The number of complications like bleeding, infections, pneumothorax and pain

  February 2017

Study Arms (2)

Study Product (19-gauge)

After randomization, the subject undergo EBUS-TBNA either with the 19-gauge needle or the 22-gauge needle

Procedure: EBUS

Control Intervention (22-gauge)

After randomization, the subject undergo EBUS-TBNA either with the 19-gauge needle or the 22-gauge needle

Procedure: EBUS

Interventions

EBUS PROCEDURE

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

Control Intervention (22-gauge); Study Product (19-gauge)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

100 Patients with lung cancer and enlarged lymph nodes will be included in this study

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Essen: lead
• University Hospital, Zürich: collaborator

Study Sites (2)

Ruhrlandklinik, University Hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

University Hospital Zürich

Zurich, Switzerland

Location

Related Publications (1)

• Wolters C, Darwiche K, Franzen D, Hager T, Bode-Lesnievska B, Kneuertz PJ, He K, Koenig M, Freitag L, Wei L, Eisenmann S, Taube C, Weinreich G, Oezkan F. A Prospective, Randomized Trial for the Comparison of 19-G and 22-G Endobronchial Ultrasound-Guided Transbronchial Aspiration Needles; Introducing a Novel End Point of Sample Weight Corrected for Blood Content. Clin Lung Cancer. 2019 May;20(3):e265-e273. doi: 10.1016/j.cllc.2019.02.019. Epub 2019 Mar 4.

  PMID: 30914312 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kaid Darwiche, PD Dr. med.

  supervising doctor

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Priv. Doz. Dr. med. Kaid Darwiche

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 27, 2016
• Study Start: May 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: July 12, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); CH (1)