Trial Comparing 19 and 25-gauge EUS-FNA Needles

NCT01677312 | Completed Results

• 1 other identifier: 356077
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Cancer of Pancreas; Pancreatic Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Procurement of Histological Samples

  30 days

• Needle Dysfunction

  2 hours

• Complications

  30 days

Study Arms (2)

19G FNA needle

ACTIVE COMPARATOR

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; Procedure: Histological Samples

25G FNA needle

ACTIVE COMPARATOR

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; Procedure: Histological Samples

Interventions

Pancreatic Biopsy PROCEDURE

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.

19G FNA needle; 25G FNA needle

Histological Samples PROCEDURE

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.

19G FNA needle; 25G FNA needle

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) Patients with solid pancreatic mass lesions.

You may not qualify if:

• 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

Sponsors & Collaborators

• AdventHealth: lead
• University of Alabama at Birmingham: collaborator

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Florida Hospital

Orlando, Florida, 32814, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Shyam Varadarajulu, MD
• Organization: Center for Interventional Endoscopy, Florida Hospital

svaradarajulu@yahoo.com

407-303-2570

Study Officials

• shyam varadarajulu, MD

  Florida Hospital Center for Interventional Endoscopy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2012
• First Posted: September 3, 2012
• Study Start: August 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 17, 2020
• Results First Posted: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)