Randomized Trial Comparing the Standard and Fanning Techniques for Fine Needle Aspiration of Pancreatic Mass Lesions at Endoscopic Ultrasound
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 52
- Locations
- 2
- Primary Endpoint
- Diagnostic accuracy
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age > 19 years
- •Solid Pancreatic Mass Lesions
Exclusion Criteria
- •Age < 19 years
- •Coagulopathy
- •Unable to consent
Outcomes
Primary Outcomes
Diagnostic accuracy
Time Frame: 2 months
The number of pancreatic masses that are correctly diagnosed with each needle type
Secondary Outcomes
- Number of passes for diagnosis(2 months)
Investigators
Shyam Varadarajulu
Principal Investigator
University of Alabama at Birmingham