A Randomized Trial Evaluating the Number of Passes Required for Diagnostic Cell Block Diring EUS-FNA of Solid Pancreatic Mass Lesions
To compare the number of passes required for obtaining adequate cell block material during
EUS-guided FNA of solid pancreatic mass lesions.
Primary Research Hypothesis:
More specimen is required to obtain definitive diagnosis on cell block. This translates to
less need for repeat procedures (due to nondiagnostic index procedure due to inadequate FNA
passes), prompt treatment to patients and better use of health care resources. Therefore, we
will be comparing 2 versus 4 FNA passes to determine which number of FNA pases will yield an
adequate diagnostic cell block.
To compare the rate of complications when performing 2 versus 4 EUS-FNA passes of solid
pancreatic mass lesions.
Secondary Research Hypothesis:
EUS-guided FNA is a safe procedure with a complication rate of < 1%. By performing more
(four) NA passes one is likely to yield a better quality cell block while at the same time
without compromising patient safety.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
number of passes
The primary endpoint of the study is to compare the number of passes required to make definitive diagnosis on cell block. This will be assessed by amount (quantity) of the sample to make the diagnosis proportionate to which group the subject was randomized to (two passes versus four passes).
up to 12 months
Shyam Varadarajulu, MD
United States: Institutional Review Board
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