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2011-09
2011-11
2011-11
52
NCT01501903
University of Alabama at Birmingham
University of Alabama at Birmingham
INTERVENTIONAL
Standard Versus Fanning Techniques for Endoscopic Ultrasound-Fine Needle Aspiration (EUS-FNA)
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.
Fanning technique: Fine Needle Aspiration (FNA) performed in multiple directions within a mass. Standard technique: FNA performed in unidirectional fashion.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2011-10-18 | N/A | 2012-02-01 |
2011-12-29 | N/A | 2012-02-02 |
2011-12-30 | N/A | 2012-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Randomized
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Standard Biopsy using standard technique of FNA | PROCEDURE: Standard
|
| OTHER: Fanning Biopsy using fanning technique | PROCEDURE: Fanning
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Diagnostic accuracy | The number of pancreatic masses that are correctly diagnosed with each needle type | 2 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of passes for diagnosis | Number of passes required to acquire tissue diagnosis using each needle type | 2 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
19 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
