Evaluating the Number of Passes Required for Diagnostic Cell Block During EUS-FNA of Solid Pancreatic Mass Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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EUS FNA with 2 passes

biopsy with 2 passes of the needle

Group Type ACTIVE_COMPARATOR

EUS FNA with 2 passes

Intervention Type PROCEDURE

biopsy with 2 passes

EUS FNA with 4 passes

biopsy with 4 passes of the needle

Group Type ACTIVE_COMPARATOR

EUS FNA with 4 passes

Intervention Type PROCEDURE

biopsy with 4 passes

Interventions

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EUS FNA with 2 passes

biopsy with 2 passes

Intervention Type PROCEDURE

EUS FNA with 4 passes

biopsy with 4 passes

Intervention Type PROCEDURE

Other Intervention Names

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Biopsy FNA biopsy FNA

Eligibility Criteria

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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)

Minimum Eligible Age

19 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No