search
Back to results

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

Primary Purpose

Cancer of Pancreas, Pancreatic Neoplasm

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pancreatic Biopsy
Histological Samples
Sponsored by
AdventHealth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cancer of Pancreas

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Florida Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

19G FNA needle

25G FNA needle

Arm Description

Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 19G FNA needle when performing pancreatic biopsy.

Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 25G FNA needle when performing pancreatic biopsy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Complications
The safety profile of the 19 and 25G needles will be compared that includes bleeding, pancreatitis and perforation.

Full Information

First Posted
August 28, 2012
Last Updated
March 3, 2020
Sponsor
AdventHealth
Collaborators
University of Alabama at Birmingham
search

1. Study Identification

Unique Protocol Identification Number
NCT01677312
Brief Title
Trial Comparing 19 and 25-gauge EUS-FNA Needles
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AdventHealth
Collaborators
University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Pancreas, Pancreatic Neoplasm

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
19G FNA needle
Arm Type
Active Comparator
Arm Description
Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 19G FNA needle when performing pancreatic biopsy.
Arm Title
25G FNA needle
Arm Type
Active Comparator
Arm Description
Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 25G FNA needle when performing pancreatic biopsy.
Intervention Type
Procedure
Intervention Name(s)
Pancreatic Biopsy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Histological Samples
Intervention Description
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.
Primary Outcome Measure Information:
Title
Median Number of Passes to Establish Diagnosis
Description
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.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Procurement of Histological Samples
Description
The ability of the 19G and 25G needles to obtain core (histological) tissue will be compared and a significance will be determined.
Time Frame
30 days
Title
Needle Dysfunction
Description
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.
Time Frame
2 hours
Title
Complications
Description
The safety profile of the 19 and 25G needles will be compared that includes bleeding, pancreatitis and perforation.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: (1) Patients with solid pancreatic mass lesions. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
shyam varadarajulu, MD
Organizational Affiliation
Florida Hospital Center for Interventional Endoscopy
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32814
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Trial Comparing 19 and 25-gauge EUS-FNA Needles

We'll reach out to this number within 24 hrs