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

NCT01501903 | Completed

• 1 other identifier: F110907002
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Tumors

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy

  The number of pancreatic masses that are correctly diagnosed with each needle type

  2 months

Secondary Outcomes (1)

• Number of passes for diagnosis

  2 months

Study Arms (2)

Standard

ACTIVE COMPARATOR

Biopsy using standard technique of FNA

Procedure: Standard

Fanning

OTHER

Biopsy using fanning technique

Procedure: Fanning

Interventions

Standard PROCEDURE

FNA in a single plane

Also known as: Standard Versus Fanning Techniques for EUS-FNA

Standard

Fanning PROCEDURE

FNA in multiple planes

Also known as: Standard Versus Fanning Techniques for EUS-FNA

Fanning

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 19 years
• Solid Pancreatic Mass Lesions

You may not qualify if:

• Age \< 19 years
• Coagulopathy
• Unable to consent

Sponsors & Collaborators

• Shyam Varadarajulu: lead

Study Sites (1)

UAB

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• Bang JY, Magee SH, Ramesh J, Trevino JM, Varadarajulu S. Randomized trial comparing fanning with standard technique for endoscopic ultrasound-guided fine-needle aspiration of solid pancreatic mass lesions. Endoscopy. 2013 Jun;45(6):445-50. doi: 10.1055/s-0032-1326268. Epub 2013 Mar 15.

  PMID: 23504490 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Shyam Varadarajulu, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 18, 2011
• First Posted: December 30, 2011
• Study Start: September 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: February 2, 2012

Record last verified: 2012-02

Locations

US (1)