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

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Procedure: biopsy with 19 gauge needle; Procedure: biopsy with 25 gauge needle

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32803
      • Florida Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 19 Gauge needle biopsy; biopsy with 19 gauge needle	Procedure: biopsy with 19 gauge needle; biopsy with 19 gauge needle; Other Names: biopsy; FNA
Active Comparator: 25 gauge needle biopsy; biopsy with 25 gauge needle	Procedure: biopsy with 25 gauge needle; biopsy with 25 gauge needle; Other Names: biopsy; FNA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of passes	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.	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Complication	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.	Up to 12 months

Collaborators and Investigators

• Sponsor: AdventHealth

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: February 26, 2013
• First Submitted That Met QC Criteria: March 19, 2013
• First Posted (Estimate): March 21, 2013

Study Record Updates

• Last Update Posted (Actual): August 3, 2017
• Last Update Submitted That Met QC Criteria: August 2, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: cancer; Pancreas; EUS-FNA; 19Gauge; 25Gauge; 35mm mass
• Other Study ID Numbers: 405581

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No