Trial Comparing 19 and 25-gauge EUS-FNA Needles (EUS-FNA)

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

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

Study Overview

• Status: Completed
• Conditions: Cancer of Pancreas; Pancreatic Neoplasm
• Intervention / Treatment: Procedure: Pancreatic Biopsy; Procedure: Histological Samples

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Florida
    • Orlando, Florida, United States, 32814
      • Florida Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 19G FNA needle; Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 19G FNA needle when performing pancreatic biopsy.	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.; Procedure: 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.
ACTIVE_COMPARATOR: 25G FNA needle; Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 25G FNA needle when performing pancreatic biopsy.	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.; Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Complications	The safety profile of the 19 and 25G needles will be compared that includes bleeding, pancreatitis and perforation.	30 days

Collaborators and Investigators

• Sponsor: AdventHealth
• Collaborators: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): January 1, 2013
• Study Completion (ACTUAL): January 1, 2013

Study Registration Dates

• First Submitted: August 28, 2012
• First Submitted That Met QC Criteria: August 29, 2012
• First Posted (ESTIMATE): September 3, 2012

Study Record Updates

• Last Update Posted (ACTUAL): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 3, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: 356077

Plan for Individual participant data (IPD)

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