Comparison of Endobronchial Ultrasound-Guided Biopsy Using Fine Needle Aspiration Versus Fine Needle Capillary Sampling
Specimen Adequacy and Diagnostic Agreement of Fine Needle Aspiration (FNA) VS. Fine Needle Capillary Sampling (FNC) of Endobronchial Ultrasound-Guided Biopsy of Mediastinal Lymph Nodes
1 other identifier
interventional
120
1 country
1
Brief Summary
Primary objective:
- To estimate the degree of agreement in diagnosis of cytologic samples from mediastinal lymph nodes obtained by Endobronchial Ultrasound (EBUS)-guided Fine Needle Capillary Sampling (FNC) versus Fine Needle Aspiration (FNA). Secondary objective:
- To compare the quality of cytologic samples from mediastinal lymph nodes obtained by EBUS-guided FNC versus FNA. The quality of the samples will be assessed initially by MDACC on-site cytology technicians, and then corroborated by physicians in the department of cytology. This assessment will be performed utilizing the Mair's score 3. The score consists of a 0-10 scale: 1-2= poor; 3-6=good; 7-10=superior.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2009
Longer than P75 for not_applicable
1 active site
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
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 21, 2009
CompletedFirst Posted
Study publicly available on registry
April 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedFebruary 19, 2016
August 1, 2012
3.3 years
April 21, 2009
February 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of times FNA and FNC agree on patient diagnosis (concordance)
2 Years
Study Arms (1)
EBUS FNA vs FNC
EXPERIMENTALInterventions
Total of two lymph nodes sampled per patient. Four biopsies will be taken from each lymph node. Two with suction (FNA) and two without suction (FNC).
Eligibility Criteria
You may qualify if:
- patients 18 years or older
- Patients in which EBUS is indicated based on the suspicion of either benign or malignant disease in mediastinal and/or hilar lymph nodes. This will include patients who are in the hospital.
You may not qualify if:
- \. patients under 18 years or younger
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT MD Anderson Cancer Center
Houston, Texas, 77007, United States
Related Publications (1)
Casal RF, Staerkel GA, Ost D, Almeida FA, Uzbeck MH, Eapen GA, Jimenez CA, Nogueras-Gonzalez GM, Sarkiss M, Morice RC. Randomized clinical trial of endobronchial ultrasound needle biopsy with and without aspiration. Chest. 2012 Sep;142(3):568-573. doi: 10.1378/chest.11-0692.
PMID: 22156610DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Rodolfo C. Morice, MD
UT MD Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2009
First Posted
April 23, 2009
Study Start
April 1, 2009
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
February 19, 2016
Record last verified: 2012-08