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OpenTrials
Completed

NCT Number: NCT01995474

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Twisted Syringe

Other

briefly disconnecting the syringe from the biopsy channel after a specimen is obtained and then reconnecting it

Conventional Technique

Other

syringe is exchanged for the needle stylet and negative pressure is applied allowing acquisition of a cytology specimen.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

Eliminating the Residual Negative Pressure in the EUS-FNA Needle Before Withdrawal Enhances the FNA Cytology Yield

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 26, 2013
Registry last updated
Nov 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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