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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01815606

Enrollment

Registered

2013-03-21

Start date

2013-02-28

Completion date

2013-12-31

Last updated

2017-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

Pancreas, cancer, EUS-FNA, 19Gauge, 25Gauge, 35mm mass

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREbiopsy with 19 gauge needle

biopsy with 19 gauge needle

PROCEDUREbiopsy with 25 gauge needle

biopsy with 25 gauge needle

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

19 Years to 89 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Number of passes	Up to 12 months	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.

Secondary

Measure	Time frame	Description
Rate of Complication	Up to 12 months	To compare the rate of complications associated with the 19G and 25G needles when sampling pancreatic tumors greater than 35mm in size. Also, the rate of needle dysfunction will be compared. Needle dysfunction is defined as, the need to use more than one needle per pancreatic tumor in an individual patient.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026