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

Primary Purpose

Pancreatic Tumors

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Standard

Fanning

About this trial

This is an interventional diagnostic trial for Pancreatic Tumors

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age > 19 years
Solid Pancreatic Mass Lesions

Exclusion Criteria:

Age < 19 years
Coagulopathy
Unable to consent

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Standard

Fanning

Arm Description

Biopsy using standard technique of FNA

Biopsy using fanning technique

Outcomes

Primary Outcome Measures

Diagnostic accuracy

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

Secondary Outcome Measures

Number of passes for diagnosis

Number of passes required to acquire tissue diagnosis using each needle type

Full Information

NCT ID

NCT01501903

First Posted

October 18, 2011

Last Updated

February 1, 2012

Sponsor

Shyam Varadarajulu

1. Study Identification

Unique Protocol Identification Number

NCT01501903

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Shyam Varadarajulu

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Tumors

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard

Arm Type

Active Comparator

Arm Description

Biopsy using standard technique of FNA

Arm Title

Fanning

Arm Type

Other

Arm Description

Biopsy using fanning technique

Intervention Type

Procedure

Intervention Name(s)

Standard

Other Intervention Name(s)

Standard Versus Fanning Techniques for EUS-FNA

Intervention Description

FNA in a single plane

Intervention Type

Procedure

Intervention Name(s)

Fanning

Other Intervention Name(s)

Standard Versus Fanning Techniques for EUS-FNA

Intervention Description

FNA in multiple planes

Primary Outcome Measure Information:

Title

Diagnostic accuracy

Description

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

Time Frame

2 months

Secondary Outcome Measure Information:

Title

Number of passes for diagnosis

Description

Number of passes required to acquire tissue diagnosis using each needle type

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age > 19 years Solid Pancreatic Mass Lesions Exclusion Criteria: Age < 19 years Coagulopathy Unable to consent

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shyam Varadarajulu, MD

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

UAB

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23504490

Citation

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.

Results Reference

derived

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

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