Simple Technique to Improve Diagnostic Yield in EUS-FNA

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

Study Description

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

• 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

Arms and Interventions

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

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

• 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

Locations

United States, Wisconsin

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

Medical College of Wisconsin

Investigators

• Principal Investigator: Kulwinder Dua, MD; Medical College of Wisconsin

More Information

Publications of Results:

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.

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

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.

• Responsible Party: Medical College of Wisconsin
• ClinicalTrials.gov Identifier: NCT01995474
• Other Study ID Numbers: PRO-00012314
• First Posted: November 26, 2013
• Last Update Posted: November 26, 2013
• Last Verified: November 2013

Keywords provided by Medical College of Wisconsin:

EUS; pancreatic cancer; cytology; fine needle aspiration