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Evaluation of EUS-Guided 22 Gauge Core Biopsy Versus Fine-needle Aspiration for Suspected Pancreatic Neoplasms

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ClinicalTrials.gov Identifier: NCT01673334
Recruitment Status : Unknown
Verified August 2012 by University of Virginia.
Recruitment status was:  Active, not recruiting
First Posted : August 27, 2012
Last Update Posted : August 27, 2012
Sponsor:
Information provided by (Responsible Party):
University of Virginia

Tracking Information
First Submitted Date  ICMJE August 22, 2012
First Posted Date  ICMJE August 27, 2012
Last Update Posted Date August 27, 2012
Study Start Date  ICMJE September 2011
Estimated Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2012)
Diagnostic Yield [ Time Frame: One-week post procedure ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of EUS-Guided 22 Gauge Core Biopsy Versus Fine-needle Aspiration for Suspected Pancreatic Neoplasms
Official Title  ICMJE Prospective Paired Evaluation of EUS-Guided 22 Gauge Core Biopsy Versus Fine-needle Aspiration for Suspected Pancreatic Neoplasms
Brief Summary We aim to compare the efficacy (diagnostic yield), ease of use, and technical success rates of EUS guided 22 gauge fine needle aspiration to core biopsy in the evaluation of pancreatic tumors. The experimental hypothesis is that FNA will have superior overall diagnostic yield than core biopsy.
Detailed Description Background: Endoscopic ultrasonography (EUS) has been utilized for over a decade to evaluate endo-luminal and adjacent tumors of the gastrointestinal tract. In that time, EUS guided fine needle aspiration (FNA) has emerged as the dominant means of tissue acquisition for pancreatic mass lesions. FNA has several limitations, foremost of which is the absence of a clear relationship between cellular elements and stroma which may be required for accurate diagnosis. Additionally, EUS-FNA requires the assistance of an on-site cytopathologist for optimal yield which limits its dissemination and increases its cost. A novel EUS histology needle (EUS-FNB) is available in the 22 gauge diameter which may allow for more accurate diagnosis without the need for on site cytopathology assistance. Aim: To prospectively compare the diagnostic yield, number of needle passes, and ease of use of 22 gauge EUS-FNA and EUS-FNB. Hypothesis: EUS-FNB is superior to traditional EUS-FNA with regard to all primary and secondary outcome measures. Methods: Patients scheduled for EUS evaluation of solid pancreatic tumors will be screened for enrollment at either a preceding clinical encounter or the morning of their scheduled procedure. English-speaking patients between the ages of 18 and 90 with a predominantly solid (greater than 60%) mass lesion of the pancreas will be considered for enrollment. Exclusion criteria include pregnancy, a predominantly cystic lesion, and the presence of an uncorrectable coagulopathy. Patients will then undergo both EUS-FNA and EUS-FNB for the collection of tissue specimens required for clinical care. The results of the experimental approach (EUS-FNB) will be compared to the control approach (EUS-FNA). Data collected for each procedure will include: instrument use order, number of needle passes with each device, technical success of each device, complications, ease of use, and the ultimate pathological diagnosis / diagnostic yield for each device. Each data category will then be compared utilizing standard statistical tests including chi-squared, Fishers' exact, or student's t test.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Pancreatic Tumor
Intervention  ICMJE Device: Fine Needle Aspiration (FNA) and Core biopsy (FNB)
Study Arms  ICMJE Experimental: Fine Needle Aspiration and Core Biospsy
Patients will undergo both FNA and core biopsy during EUS evaluation of a solid pancreatic tumor.
Intervention: Device: Fine Needle Aspiration (FNA) and Core biopsy (FNB)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 24, 2012)
40
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age greater than 18 and less than 90 years.
  • Presence of a solid (greater than 60%) mass lesion within the pancreas on cross-sectional imaging, without a preceding tissue diagnosis.
  • Absence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not correct with the administration of fresh frozen plasma.
  • The patient must read and speak english and has signed informed consent document.
  • The patient is scheduled for diagnostic endosonography by their referring provider or UVa gastroenterologist.

Exclusion Criteria:

  • Age less than 18 or greater than 90 years.
  • The patient is unable to read or understand the consent form.
  • The patient is currently pregnant.
  • The patient has an uncorrectable coagulopathy as defined by a prolonged prothrombin time (PT) or partial thromboplastin time (PTT) which does not improve with administration of fresh frozen plasma.
  • The patient has a pancreatic mass lesion which is predominantly cystic (greater than 40%).
  • No mass lesion is identified at the time of endosonography.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01673334
Other Study ID Numbers  ICMJE 15779
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Virginia
Study Sponsor  ICMJE University of Virginia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vanessa Shami, MD University of Virginia
PRS Account University of Virginia
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP