Status:
UNKNOWN
A Randomized Controlled Trial Of Endoscopic Ultrasound-Guided Fine-Needle Aspiration With And Without A Stylet
Lead Sponsor:
American Society for Gastrointestinal Endoscopy
Collaborating Sponsors:
Midwest Biomedical Research Foundation
Conditions:
Mediastinal or Intra-abdominal Lymphadenopathy,
Pancreatic Masses,
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) has become an important tool in the diagnostic evaluation of gastrointestinal tract lesions and other organ sites such as mediastinal and ...
Detailed Description
Various techniques have been described to optimize accuracy, efficiency, and quality of EUS-FNA specimens. FNA is typically performed using a 22- or 25-gauge needle with a stylet under EUS guidance. T...
Eligibility Criteria
Inclusion
- Age greater than 18 years
- Presence of mediastinal or intra-abdominal lymphadenopathy, solid pancreatic mass, left adrenal mass, gastrointestinal submucosal lesions or liver mass confirmed by at least a single investigational modality - CT scan, magnetic resonance imaging, endoscopy.
- Capable of providing informed consent
Exclusion
- Severe coagulopathy (INR \> 1.5) or thrombocytopenia (platelet count \< 50,000)
- Lesion unable to be sampled due to the presence of intervening blood vessels
- Results of EUS-FNA would not impact patient management
- Inability to provide informed consent
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01213290
Start Date
September 1 2009
End Date
March 1 2010
Last Update
October 1 2010
Active Locations (2)
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1
Kansas City VA Medical Center
Kansas City, Missouri, United States, 64128
2
Veterans Affairs Medical Center
Kansas City, Missouri, United States, 64128