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

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ClinicalTrials.gov Identifier: NCT01809028
Recruitment Status : Completed
First Posted : March 12, 2013
Last Update Posted : August 3, 2017
Sponsor:
Collaborator:
University of Alabama at Birmingham
Information provided by (Responsible Party):
Florida Hospital

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Procedure: EUS FNA with 2 passes Procedure: EUS FNA with 4 passes Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
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 Start Date : February 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Active Comparator: EUS FNA with 2 passes
biopsy with 2 passes of the needle
Procedure: EUS FNA with 2 passes
biopsy with 2 passes
Other Names:
  • Biopsy
  • FNA

Active Comparator: EUS FNA with 4 passes
biopsy with 4 passes of the needle
Procedure: EUS FNA with 4 passes
biopsy with 4 passes
Other Names:
  • biopsy
  • FNA




Primary Outcome Measures :
  1. number of passes [ Time Frame: up to 12 months ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809028


Locations
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United States, Florida
Florida Hospital
Orlando, Florida, United States, 32803
Sponsors and Collaborators
Florida Hospital
University of Alabama at Birmingham
Investigators
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Principal Investigator: Shyam Varadarajulu, MD Florida Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Florida Hospital
ClinicalTrials.gov Identifier: NCT01809028     History of Changes
Other Study ID Numbers: 407129
First Posted: March 12, 2013    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Florida Hospital:
cell block, number of passes

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases