Trial Comparing 19 and 25-gauge EUS-FNA Needles

Cancer of Pancreas Clinical Trial

— EUS-FNA  

Official title:

Multi-Center Randomized Trial Comparing 19 and 25-gauge Needles for Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) of Solid Pancreatic Mass Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01677312
• Other study ID #: 356077
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: January 2013

Study information

• Verified date: March 2020
• Source: Florida Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study compares the 19G and 25G needles for procuring tissue samples from the pancreas during Endoscopic Ultrasound (EUS) procedures.

Description:

The study compares the median number of passes to establish a definitive diagnosis using the 19G or 25G needles. Also, the ability of both needles to procure a histological core tissue is assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

INCLUSION CRITERIA:

(1) Patients with solid pancreatic mass lesions.

EXCLUSION CRITERIA:

1. Age < 19 years

2. Unable to safely undergo EUS for any reason

3. Coagulopathy (INR > 1.6, Prothrombin Time > 18secs, Thrombocytopenia < 80,000 cells/ml)

4. Unable to consent

5. Non-English speaking patients

Related Conditions & MeSH terms

• Cancer of Pancreas
• Pancreatic Neoplasm
• Pancreatic Neoplasms

Intervention

Procedure:
• Pancreatic Biopsy
A FNA needle will be used to biopsy the pancreatic mass. The rates of diagnostic accuracy (%) will be assessed. Diagnostic accuracy is defined as the proportion of patients in whom a definitive diagnosis can be obtained within a predetermined number of FNA passes.
• Histological Samples
The proportion of patients (%) in whom a histological tissue can be obtained when performing a biopsy of the pancreas using a specific needle will be assessed.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Florida Hospital	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida Hospital	University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Number of Passes to Establish Diagnosis	To compare the median number of passes required to establish diagnosis using the 19G and 25G needles for FNA of solid pancreatic mass lesions. This will be measured by comparing the rates of diagnostic accuracy (%) between both needle types.	5 months
Secondary	Procurement of Histological Samples	The ability of the 19G and 25G needles to obtain core (histological) tissue will be compared and a significance will be determined.	30 days
Secondary	Needle Dysfunction	The percentage of cases in which needle dysfunction occurs will be compared between the 19G and 25G needle types. Needle dysfunction will be defined as the need to use more than one FNA needle per lesion in an individual patient.	2 hours
Secondary	Complications	The safety profile of the 19 and 25G needles will be compared that includes bleeding, pancreatitis and perforation.	30 days