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

Pancreatic Tumors Clinical Trial

Official title:

Randomized Trial Comparing the Standard and Fanning Techniques for Fine Needle Aspiration of Pancreatic Mass Lesions at Endoscopic Ultrasound

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01501903
• Other study ID #: F110907002
• Status: Completed
• Phase: N/A
• First received: October 18, 2011
• Last updated: February 1, 2012
• Start date: September 2011
• Est. completion date: November 2011

Study information

• Verified date: February 2012
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Standard technique: FNA performed in unidirectional fashion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age > 19 years

• Solid Pancreatic Mass Lesions

Exclusion Criteria:

• Age < 19 years

• Coagulopathy

• Unable to consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pancreatic Neoplasms
• Pancreatic Tumors

Intervention

Procedure:
• Standard
FNA in a single plane
• Fanning
FNA in multiple planes

Locations

Country	Name	City	State
United States	UAB	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Shyam Varadarajulu

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy	The number of pancreatic masses that are correctly diagnosed with each needle type	2 months	No
Secondary	Number of passes for diagnosis	Number of passes required to acquire tissue diagnosis using each needle type	2 months	No