Trial Comparing 19 and 25G Needles for Fine Needle Aspiration (FNA) of Solid Pancreatic Mass Lesions Greater Than 35mm
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 19 - 89 |
| Updated: | 8/4/2017 |
| Start Date: | February 2013 |
| End Date: | December 2013 |
Randomized Trial Comparing 19 and 25G Needles for Fine Needle Aspiration (FNA) of Solid Pancreatic Mass Lesions Greater Than 35mm
This study will test two different needles for performing a biopsy of the pancreas during
endoscopic ultrasound (EUS) procedures. Patients who are asked to participate in this study
have a growth in the pancreas measuring greater than 35mm that needs a biopsy so that a
diagnosis can be made. The biopsy can be performed using either a 19 or 25-Gauge needle. The
purpose of this study is to compare which of the two needles is better for performing
biopsies of the pancreas on masses that are greater than 35mm.
endoscopic ultrasound (EUS) procedures. Patients who are asked to participate in this study
have a growth in the pancreas measuring greater than 35mm that needs a biopsy so that a
diagnosis can be made. The biopsy can be performed using either a 19 or 25-Gauge needle. The
purpose of this study is to compare which of the two needles is better for performing
biopsies of the pancreas on masses that are greater than 35mm.
Endoscopic Ultrasound-guided fine needle aspiration (EUS-FNA) can be performed using the 25,
22 or 19 gauge (G) needles. Randomized trials have shown that all three needles are safe and
perform equally well. However, in a retrospective study, the diagnostic sensitivity of
EUS-FNA for pancreatic masses that measured more than 35mm was less compared to smaller size
masses. This is because larger size tumors have more necrosis and it is difficult to identify
cancer cells in them to make a diagnosis. Therefore, more biopsies must be performed in
larger size tumors to establish a diagnosis. In previous studies it has been shown that the
larger 19G needles procure larger and better quality tissue. Therefore, our hypothesis is
that, when a larger 19G needle is used to FNA tumors more than 35mm, a diagnosis can be
achieved with fewer passes.
22 or 19 gauge (G) needles. Randomized trials have shown that all three needles are safe and
perform equally well. However, in a retrospective study, the diagnostic sensitivity of
EUS-FNA for pancreatic masses that measured more than 35mm was less compared to smaller size
masses. This is because larger size tumors have more necrosis and it is difficult to identify
cancer cells in them to make a diagnosis. Therefore, more biopsies must be performed in
larger size tumors to establish a diagnosis. In previous studies it has been shown that the
larger 19G needles procure larger and better quality tissue. Therefore, our hypothesis is
that, when a larger 19G needle is used to FNA tumors more than 35mm, a diagnosis can be
achieved with fewer passes.
Inclusion Criteria:
All patients referred to Florida Hospital Endoscopy Unit for assessment of pancreatic mass
lesions greater than 35 mm on computed tomography (CT) that require FNA.
Exclusion Criteria:
- Age < 19 years
- Unable to safely undergo EUS for any reason
- Coagulopathy (INR >1.6, Prothrombin Time >18secs, Thrombocytopenia <80,000 cells/ml)
- Unable to consent
- Non-English speaking patients
- Participation in any other clinical trial (excluding registries or databases)
We found this trial at
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Florida Hospital Florida Hospital is one of the country
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