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Simple Technique to Improve Diagnostic Yield in EUS-FNA

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ClinicalTrials.gov Identifier: NCT01995474
Recruitment Status : Completed
First Posted : November 26, 2013
Last Update Posted : November 26, 2013
Sponsor:
Information provided by (Responsible Party):
Medical College of Wisconsin

Study Description
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Brief Summary:
Endoscopic ultrasound and fine needle aspiration are useful tools for the diagnosis and staging of pancreatic cancer. One potential limitation is contamination when needle traverses the gastrointestinal tract under continuous negative pressure. Gastrointestinal tract contamination can lead to misinterpretation of FNA specimens. We propose a technique to eliminate any remaining negative pressure during EUS-FNA and therefore decrease gastrointestinal tract contamination. Our hypothesis is that briefly untwisting the syringe from the biopsy channel after a specimen is obtained eliminates any remaining negative pressure in the FNA needle and therefore reduces GI tract contamination of EUS-FNA specimens, and will lead to improved diagnostic accuracy of this important clinical technique.

Condition or disease Intervention/treatment Phase
Lesion Sampled for Cytology Other: Twisted Syringe Other: Conventional Technique Not Applicable

Detailed Description:

Endoscopic ultrasound (EUS) has evolved into a minimally invasive diagnostic and staging method. The addition of fine needle aspiration (FNA) increases the accuracy of EUS in the diagnosis and staging of pancreatic malignancies. An ultrasound probe attached to the end of the endoscope allows real-time direct visualization by means of ultrasound transmission. During the FNA process a needle is advanced through the biopsy channel of the endoscope and into the target lesion. In order to obtain a tissue specimen of a suspicious pancreatic lesion, an FNA needle must traverse either the stomach or duodenum to access the pancreatic mass. Once the needle has entered the target lesion a syringe is exchanged for the needle stylet and negative pressure is applied allowing acquisition of a cytology specimen. Negative pressure is released from the syringe and the stop cock is closed to the syringe. However, due to the relatively long length of the needle there is is significant remaining negative pressure at the needle tip. This leads to aspiration of surrounding material including GI mucosal contamination into the needle while removing it from the target lesion.

Contamination of the FNA specimen from gastric or duodenal epithelium can occur with continued negative pressure at the needle tip upon withdrawal of the needle out of the target lesion. While EUS-FNA has a high specificity (96%), sensitivity (87%), and accuracy (94%), gastrointestinal tract contamination can lead to misinterpretation of FNA specimens. Based on clinical experience, we propose a technique to eliminate any remaining negative pressure during EUS-FNA and therefore decreasing gastrointestinal tract contamination.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Eliminating the Residual Negative Pressure in the EUS-FNA Needle Before Withdrawal Enhances the FNA Cytology Yield
Study Start Date : February 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Twisted Syringe
briefly disconnecting the syringe from the biopsy channel after a specimen is obtained and then reconnecting it
 Other: Twisted Syringe
briefly disconnecting the syringe from the biopsy channel after a specimen is obtained and then reconnecting it
Active Comparator: Conventional Technique
syringe is exchanged for the needle stylet and negative pressure is applied allowing acquisition of a cytology specimen.
 Other: Conventional Technique
syringe is exchanged for the needle stylet and negative pressure is applied allowing acquisition of a cytology specimen.


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy of FNA biopsy [ Time Frame: 1 week ]
    The efficacy of fine needle aspiration is assessed using on site cytopathologists who are blinded with respect to the study ARM. The efficacy of diagnostic yield from samples obtained using the needle-off technique is directly compared to the diagnostic yield of samples obtained using conventional technique.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18
  • Not pregnant
  • Can give consent
  • Patients with suspicious GI lesions in need of tissue diagnosis by means of EUS/FNA

Exclusion Criteria:

  • Pregnant
  • Age < 18
  • Cannot give consent
  • EUS not technically possible
Contacts and Locations
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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): NCT01995474


Locations
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United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
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Principal Investigator: Kulwinder Dua, MD Medical College of Wisconsin
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01995474    
Other Study ID Numbers: PRO-00012314
First Posted: November 26, 2013    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: November 2013
Keywords provided by Medical College of Wisconsin:
EUS
pancreatic cancer
cytology
fine needle aspiration