Viewing Study NCT01501903


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Study NCT ID: NCT01501903
Status: COMPLETED
Last Update Posted: 2012-02-02
First Post: 2011-10-18
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Standard Versus Fanning Techniques for Endoscopic Ultrasound-Fine Needle Aspiration (EUS-FNA)
Sponsor: Shyam Varadarajulu
Organization:

Study Overview

Official Title: Randomized Trial Comparing the Standard and Fanning Techniques for Fine Needle Aspiration of Pancreatic Mass Lesions at Endoscopic Ultrasound
Status: COMPLETED
Status Verified Date: 2012-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: