NCT01995474

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2013

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 26, 2013

Completed
Last Updated

November 26, 2013

Status Verified

November 1, 2013

Enrollment Period

2.7 years

First QC Date

April 30, 2013

Last Update Submit

November 21, 2013

Conditions

Lesion Sampled for Cytology

Keywords

EUSpancreatic cancercytologyfine needle aspiration

Outcome Measures

Primary Outcomes (1)

  • Efficacy of FNA biopsy

    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.

    1 week

Study Arms (2)

Twisted Syringe

EXPERIMENTAL

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

Other: Twisted Syringe

Conventional Technique

ACTIVE COMPARATOR

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

Other: Conventional Technique

Interventions

Twisted SyringeOTHER

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

Twisted Syringe
Conventional TechniqueOTHER

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

Conventional Technique

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Pregnant
  • Age \< 18
  • Cannot give consent
  • EUS not technically possible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (2)

  • 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.

    PMID: 16417563RESULT

  • 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.

    PMID: 26346997DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Kulwinder Dua, MD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2013

First Posted

November 26, 2013

Study Start

February 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

November 26, 2013

Record last verified: 2013-11

Locations

US(1)