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

NCT ID: NCT01501903

Last Updated: 2012-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2011-11-30

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.

Conditions

Pancreatic Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Standard

Biopsy using standard technique of FNA

Group Type: ACTIVE_COMPARATOR

Standard

Intervention Type: PROCEDURE

FNA in a single plane

Fanning

Biopsy using fanning technique

Group Type: OTHER

Fanning

Intervention Type: PROCEDURE

FNA in multiple planes

Interventions

Standard

FNA in a single plane

Intervention Type: PROCEDURE

Fanning

FNA in multiple planes

Intervention Type: PROCEDURE

Other Intervention Names

Standard Versus Fanning Techniques for EUS-FNA; Standard Versus Fanning Techniques for EUS-FNA

Eligibility Criteria

Inclusion Criteria

• Age > 19 years
• Solid Pancreatic Mass Lesions

Exclusion Criteria

• Age < 19 years
• Coagulopathy
• Unable to consent

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shyam Varadarajulu

OTHER

Sponsor Role: lead

Responsible Party

Shyam Varadarajulu

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Shyam Varadarajulu, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

UAB

Birmingham, Alabama, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23504490 (View on PubMed)

Other Identifiers

F110907002

Identifier Type: -

Identifier Source: org_study_id