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A Randomized Trial Evaluating the Number of Passes Required for Diagnostic Cell Block Diring EUS-FNA of Solid Pancreatic Mass Lesions


N/A
19 Years
89 Years
Open (Enrolling)
Both
Pancreatic Cancer

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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