Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02813603
Recruitment Status : Completed
First Posted : June 27, 2016
Last Update Posted : July 12, 2018
Sponsor:
Collaborator:
University Hospital, Zürich
Information provided by (Responsible Party):
Kaid Darwiche, University Hospital, Essen

Tracking Information
First Submitted Date June 16, 2016
First Posted Date June 27, 2016
Last Update Posted Date July 12, 2018
Study Start Date May 2016
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 10, 2018)
sample weight [ Time Frame: February 2017 ]
Original Primary Outcome Measures
 (submitted: June 22, 2016)
Sensitivity, specificity, accuracy [ Time Frame: February 2017 ]
Change History
Current Secondary Outcome Measures
 (submitted: July 10, 2018)
The number of complications like bleeding, infections, pneumothorax and pain [ Time Frame: February 2017 ]
Original Secondary Outcome Measures
 (submitted: June 22, 2016)
Number of tumor cells and lymphocytes within 10 HPF [ Time Frame: February 2017 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: June 22, 2016)
The number of complications like bleeding, infections, pneumothorax and pain [ Time Frame: February 2017 ]
 
Descriptive Information
Brief Title Comparison of 22-gauge and 19-gauge Aspiration Needle During EBUS-TBNA
Official Title Comparison of the Diagnostic Yield Between Various Endobronchial Ultrasound-guided-transbronchial Needles (EBUS-TBN) to Evaluate Suspect Mediastinal and Hilar Lymph Nodes
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.
Detailed 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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 100 Patients with lung cancer and enlarged lymph nodes will be included in this study
Condition 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.
Study Groups/Cohorts
  • Study Product (19-gauge)
    After randomization, the subject undergo EBUS-TBNA either with the 19-gauge needle or the 22-gauge needle
    Intervention: Procedure: EBUS
  • Control Intervention (22-gauge)
    After randomization, the subject undergo EBUS-TBNA either with the 19-gauge needle or the 22-gauge needle
    Intervention: Procedure: EBUS
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 22, 2016)
100
Original Estimated Enrollment Same as current
Actual Study Completion Date March 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02813603
Other Study ID Numbers EBUS19VS22
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Kaid Darwiche, University Hospital, Essen
Study Sponsor University Hospital, Essen
Collaborators University Hospital, Zürich
Investigators
Study Director: Kaid Darwiche, PD Dr. med. supervising doctor
PRS Account University Hospital, Essen
Verification Date July 2018