Clinical trial NCT01809028: Evaluating the Number of Passes Required for Diagnostic Cell Block During EUS-FNA of Solid Pancreatic Mass Lesions
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Keywords: cell block, number of passes
Lead sponsor: AdventHealth
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
First posted: 2013-03-12
Enrollment: 62
Sex: ALL
Minimum age (years): 19
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: number of passes
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
Study officials:
affiliation: AdventHealth
name: Shyam Varadarajulu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Varadarajulu S, Bang JY, Holt BA, Hasan MK, Logue A, Hawes RH, Hebert-Magee S. The 25-gauge EUS-FNA needle: Good for on-site but poor for off-site evaluation? Results of a randomized trial. Gastrointest Endosc. 2014 Dec;80(6):1056-63. doi: 10.1016/j.gie.2014.05.304. Epub 2014 Jun 25.