Liver Masses Clinical Trial
Official title:
A Randomized Controlled Trial Of Endoscopic Ultrasound-Guided Fine-Needle Aspiration With And Without A Stylet : A Pilot Study
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 intra-abdominal lymphadenopathy, pancreatic masses, liver masses, left
adrenal masses and gastrointestinal submucosal lesions. It provides crucial information that
can have tremendous impact on patient management. FNA is typically performed using a 22- or
25-gauge needle with a stylet under EUS guidance. The lesion is punctured with a stylet in
place in the needle. After withdrawal of the stylet, the needle is moved to and fro within
the lesion and this process is repeated for each needle pass. It is currently believed that
the use of a stylet for EUS-FNA improves the quality of specimens by preventing the tip of
the needle being clogged up with tissue and hence enhances the diagnostic yield of specimens
obtained. However, there are no data demonstrating clearly that the use of a stylet improves
the yield of EUS-FNA. The reason why this question is important is because the use of a
stylet during EUS-FNA is cumbersome, time and energy consuming and increases the costs of
EUS-FNA needle systems.
In this prospective randomized controlled trial, patients referred for EUS-FNA of
mediastinal and intra-abdominal lymphadenopathy, pancreatic mass, liver mass, left adrenal
mass and gastrointestinal submucosal tumors will be included. FNA will be performed with a
22-gauge needle under EUS guidance using suction with a 10 mL syringe by two experienced
endosonographers. The technique to be used for fine needle sampling i.e. with a stylet in
place or without a stylet for each FNA pass will be assigned by using a preprinted
randomization scheme obtained from a sealed envelope and clearly documented. Each lesion
will be sampled for a minimum of four needle passes. The pathologists providing the final
interpretation will be blinded to technique of EUS-FNA (with or without stylet). The degree
of cellularity, contamination, amount of blood, adequacy of sample, frequency with which a
positive diagnosis is made will be compared between the two groups (EUS-FNA with stylet vs.
EUS-FNA without stylet). The sensitivity, specificity, accuracy, positive predictive value
and negative predictive value of each technique when compared to the final diagnosis will be
calculated. Inter-observer agreement among cytopathologists will be assessed for specimens
obtained from EUS-FNA with stylet and for those obtained from EUS-FNA without a stylet.
| Status | Active, not recruiting |
| Enrollment | 100 |
| Est. completion date | March 2010 |
| Est. primary completion date | March 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 85 Years |
| Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| United States | Kansas City VA Medical Center | Kansas City | Missouri |
| United States | Veterans Affairs Medical Center | Kansas City | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| American Society for Gastrointestinal Endoscopy | Midwest Biomedical Research Foundation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To compare the degree of cellularity, contamination, and amount of blood in samples obtained by EUS-FNA with and without a stylet | First hypothesis: There is no difference in the degree of cellularity, contamination, and amount of blood in samples obtained by EUS-FNA with and without a stylet Specific Aim #1: To compare the degree of cellularity, contamination, and amount of blood in samples obtained by EUS-FNA with and without a stylet | 2 years | No |
| Secondary | To compare the diagnostic yield of malignancy in specimens obtained by EUS-FNA with and without a stylet. | Second hypothesis: There is no difference in the diagnostic yield of malignancy in specimens obtained by EUS-FNA with a stylet compared with EUS-FNA without a stylet. Specific Aim #2: To compare the diagnostic yield of malignancy in specimens obtained by EUS-FNA with and without a stylet. |
2 years | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01016288 -
Controlled Trial Comparing the Performance of 22 Gauge Versus 25 Gauge EUS-FNA Needles (FNA-22G-25G)
|
N/A |