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

Not Applicable

Completed

• Conditions: Pancreatic Cancer
• Interventions: Procedure: biopsy with 19 gauge needle; Procedure: biopsy with 25 gauge needle

• Registration Number: NCT01815606
• Lead Sponsor: AdventHealth

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-26
• Study First Submitted QC: 2013-03-19
• Study First Posted: 2013-03-21
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-02
• Last Update Posted: 2017-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
19 Gauge needle biopsy	biopsy with 19 gauge needle	biopsy with 19 gauge needle
25 gauge needle biopsy	biopsy with 25 gauge needle	biopsy with 25 gauge needle

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Florida Hospital; 🇺🇸 Orlando, Florida, United States