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Randomized Trial Comparing 19 and 25G Needles for Fine Needle Aspiration (FNA) of Solid Pancreatic Mass Lesions Greater Than 35mm

19 Years
89 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

Randomized Trial Comparing 19 and 25G Needles for Fine Needle Aspiration (FNA) of Solid Pancreatic Mass Lesions 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.

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)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Outcome Measure:

Number of passes

Outcome Description:

The use of a 19G FNA needle reduces the number of passes required to establish a diagnosis in pancreatic tumors that are greater than 35mm in size. This translates to less sedation, faster patient recovery, better safety and time efficiency.

Outcome Time Frame:

Up to 12 months

Safety Issue:


Principal Investigator

Shyam Varadarajulu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Florida Hospital


United States: Institutional Review Board

Study ID:




Start Date:

February 2013

Completion Date:

December 2013

Related Keywords:

  • Pancreatic Cancer
  • Pancreas
  • cancer
  • 19Gauge
  • 25Gauge
  • 35mm mass
  • Pancreatic Neoplasms



Florida HospitalOrlando, Florida  32803