A Randomized Trial Evaluating the Number of Passes Required for Diagnostic Cell Block Diring EUS-FNA of Solid Pancreatic Mass Lesions
19 Years
89 Years
Both
Pancreatic Cancer
Trial Information
A Randomized Trial Evaluating the Number of Passes Required for Diagnostic Cell Block Diring EUS-FNA of Solid Pancreatic Mass Lesions
Primary Aim:
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.
Secondary Aims:
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.
Inclusion Criteria:
1) All patients referred to Florida Hospital Endoscopy Unit for assessment of pancreatic
mass lesions that require FNA.
Exclusion Criteria:
1. Age <19 years
2. Unable to safely undergo EUS for any reason
3. Coagulopathy (INR >1.6, Prothrombin Time >18secs, Thrombocytopenia <80,000 cells/ml)
4. Unable to consent
5. Non-English speaking patients.
6. Participation in any other Clinical Trial (excluding registries and databases)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
Outcome Measure:
number of passes
Outcome Description:
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).
Outcome Time Frame:
up to 12 months
Safety Issue:
No
Principal Investigator
Shyam Varadarajulu, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Florida Hospital
Authority:
United States: Institutional Review Board
Study ID:
407129
NCT ID:
NCT01809028
Start Date:
February 2013
Completion Date:
January 2014
Related Keywords:
- Pancreatic Cancer
- cell block, number of passes
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Florida Hospital | Orlando, Florida 32803 |
