Standard Versus Fanning Techniques for Endoscopic Ultrasound-Fine Needle Aspiration (EUS-FNA)

Not Applicable

Completed

• Conditions: Pancreatic Tumors

• Registration Number: NCT01501903
• Lead Sponsor: Shyam Varadarajulu

Brief Summary

Endoscopic Ultrasound (EUS)-guided biopsy is the most ideal technique for evaluating a growth in the pancreas. EUS-guided biopsies yield a definitive diagnosis in greater than 80% of cases. In 15-20% of the cases, a definitive diagnosis cannot be made despite multiple attempts. One of the reasons why a diagnosis cannot be made is due to the focal location of the cancer; i.e., the cancer can be situated in a corner of a big mass and the needle fails to sample the cancer cells. The fanning technique is a method where the needle moves in multiple directions within a mass and therefore there is a better chance of the cancer cells being sampled compared to the standard technique where the needle moves in only one direction. The diagnostic performance of both these techniques has not been compared in a randomized fashion.

Detailed Description

Fanning technique: Fine Needle Aspiration (FNA) performed in multiple directions within a mass.

Standard technique: FNA performed in unidirectional fashion.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-18
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Study First Submitted QC: 2011-12-29
• Study First Posted: 2011-12-30
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-01
• Last Update Posted: 2012-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Age > 19 years
• Solid Pancreatic Mass Lesions

Exclusion Criteria

• Age < 19 years
• Coagulopathy
• Unable to consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy	2 months	The number of pancreatic masses that are correctly diagnosed with each needle type

Secondary Outcome Measures

Name	Time	Method
Number of passes for diagnosis	2 months	Number of passes required to acquire tissue diagnosis using each needle type

Trial Locations

Locations (1)

UAB; 🇺🇸 Birmingham, Alabama, United States