Simple Technique to Improve Diagnostic Yield in EUS-FNA

NCT ID: NCT01995474

Last Updated: 2013-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2012-10-31

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.

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.

Conditions

Lesion Sampled for Cytology

Keywords

EUS; pancreatic cancer; cytology; fine needle aspiration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Twisted Syringe

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

Group Type: EXPERIMENTAL

Twisted Syringe

Intervention Type: OTHER

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

Conventional Technique

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

Group Type: ACTIVE_COMPARATOR

Conventional Technique

Intervention Type: OTHER

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

Interventions

Twisted Syringe

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

Intervention Type: OTHER

Conventional Technique

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kulwinder Dua, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 16417563 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26346997 (View on PubMed)

Other Identifiers

PRO-00012314

Identifier Type: -

Identifier Source: org_study_id