Evaluating the Number of Passes Required for Diagnostic Cell Block During EUS-FNA of Solid Pancreatic Mass Lesions
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 19 - 89 |
| Updated: | 8/4/2017 |
| Start Date: | February 2013 |
| End Date: | January 2014 |
A Randomized Trial Evaluating the Number of Passes Required for Diagnostic Cell Block During Endoscopic Ultrasound-Fine Needle Aspiration of Solid Pancreatic Mass Lesions
This study will test the amount of tissue, called "cell block", obtained from your pancreas.
Patients who are asked to participate in this study have a growth (mass) in the pancreas that
needs a biopsy so a diagnosis can be made. Although we usually perform 2 to 4 passes (number
of times the doctor biopsies the mass), at this time we do not know the ideal number of
passes needed to obtain adequate amount of tissue for making a diagnosis. The purpose of this
study is to compare the amount of tissue obtained with 2 passes versus 4 passes.
Patients who are asked to participate in this study have a growth (mass) in the pancreas that
needs a biopsy so a diagnosis can be made. Although we usually perform 2 to 4 passes (number
of times the doctor biopsies the mass), at this time we do not know the ideal number of
passes needed to obtain adequate amount of tissue for making a diagnosis. The purpose of this
study is to compare the amount of tissue obtained with 2 passes versus 4 passes.
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.
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)
We found this trial at
1
site
Florida Hospital Florida Hospital is one of the country
Click here to add this to my saved trials
