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Simple Technique to Improve Diagnostic Yield in EUS-FNA


2010-02


2012-10


2012-10


60

Study Overview

Simple Technique to Improve Diagnostic Yield in EUS-FNA

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.

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.

  • Lesion Sampled for Cytology
  • OTHER: Twisted Syringe
  • OTHER: Conventional Technique
  • PRO-00012314

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2013-04-30  

N/A  

2013-11-21  

2013-11-21  

N/A  

2013-11-26  

2013-11-26  

N/A  

2013-11  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic


Allocation:
Randomized


Interventional Model:
Single Group


Masking:
Single


Arms and Interventions

Participant Group/ArmIntervention/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.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Efficacy of FNA biopsyThe 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.1 week
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.


    • PRINCIPAL_INVESTIGATOR: Kulwinder Dua, MD, Medical College of Wisconsin

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    • Mitsuhashi T, Ghafari S, Chang CY, Gu M. Endoscopic ultrasound-guided fine needle aspiration of the pancreas: cytomorphological evaluation with emphasis on adequacy assessment, diagnostic criteria and contamination from the gastrointestinal tract. Cytopathology. 2006 Feb;17(1):34-41. doi: 10.1111/j.1365-2303.2006.00277.x.
    • Aadam AA, Oh YS, Shidham VB, Khan A, Hunt B, Rao N, Zhang Y, Tarima S, Dua KS. Eliminating the Residual Negative Pressure in the Endoscopic Ultrasound Aspirating Needle Enhances Cytology Yield of Pancreas Masses. Dig Dis Sci. 2016 Mar;61(3):890-9. doi: 10.1007/s10620-015-3860-0. Epub 2015 Sep 7.