Evaluating the Number of Passes Required for Diagnostic Cell Block During EUS-FNA of Solid Pancreatic Mass Lesions
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|ClinicalTrials.gov Identifier: NCT01809028|
Recruitment Status : Completed
First Posted : March 12, 2013
Last Update Posted : August 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Procedure: EUS FNA with 2 passes Procedure: EUS FNA with 4 passes||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomized Trial Evaluating the Number of Passes Required for Diagnostic Cell Block During Endoscopic Ultrasound-Fine Needle Aspiration of Solid Pancreatic Mass Lesions|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
Active Comparator: EUS FNA with 2 passes
biopsy with 2 passes of the needle
Procedure: EUS FNA with 2 passes
biopsy with 2 passes
Active Comparator: EUS FNA with 4 passes
biopsy with 4 passes of the needle
Procedure: EUS FNA with 4 passes
biopsy with 4 passes
- number of passes [ Time Frame: up to 12 months ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809028
|United States, Florida|
|Orlando, Florida, United States, 32803|
|Principal Investigator:||Shyam Varadarajulu, MD||Florida Hospital|