Comparison of "Wet Suction" Technique to Contemporary "Dry Suction" Technique Using a 22 Gauge Needle for EUS FNA

This study is currently recruiting participants.
Verified January 2014 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01720745
First received: October 25, 2012
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

ROLE OF SUCTION IN EUS-FNA: Current suction technique involves suctioning the aspirate into the needle that has an air column. The needle is not flushed with any liquid prior to passing into the desired solid lesion. Suction is applied when the needle is within the lesion leading to aspiration of tissue into the needle. This is the standard technique and some have done with and without the stylet. There are some data that favor non use of a stylet.

WET SCTION TECHNIQUE:

Wet suction technique involves flushing the needle with 1-2 cc of saline to replace the column of air with saline. The needle is now passed into the desired lesion. Suction is applied at maximal strength and needle moved back and forth within the lesion to obtain as aspirate. Drops of saline can be seen moving into the suction syringe as the aspirate moves into the needle. Needle is now withdrawn and aspirate delivered on to a slide by using a stylet and or flushing air into the needle with a syringe.

HYPOTHESIS The effect of suction for the purpose of aspirating cells and / or tissue during fine needle biopsy may be significantly improved by filling the column of the needle with a less compressible fluid. The volume of vacuum being pulled may be negatively impacted by the expansion of air within the needle. Replacing the air with sterile saline may thus improve the suction transferred to the needle tip by ensuring that the full volume of the vacuum syringe is transferred to the distal tip of the needle. This effect would be most pronounced in larger gauge needles which would have a larger internal volume. An additional benefit of filling the needle with saline prior to aspiration is the speed of the pressure transfer. The theory is that the air in the needle may absorb some of the force of the sudden application of vacuum. A column of saline in the needle may increase the velocity of the pressure transfer providing more tissue and less blood.


Condition
Cancer
Infection
Inflammation
Tumor
Sarcoid
Lymphadenopathy
Lymphoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of "Wet Suction" Technique to Contemporary "Dry Suction" Technique Using a 22 Gauge Needle for EUS FNA of Solid Lesions. A Randomized, Prospective, Blinded, and Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Quality of cellularity obtained by wet suction and conventional dry suction technique [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The aspirate will be evaluated by a pathologist, blinded to the suction technique, to reach a cytological diagnosis. The pathologist will determine the quality of aspirate, grading it based on cellularity.


Secondary Outcome Measures:
  • Diagnostic ability of final cytopathology at cell-block [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Cell block made from the aspirate will be evaluated for ability to reach a final pathological diagnosis.

  • Presence of blood and other contaminants. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The aspirate will be evaluated by a pathologist, blinded to the suction technique, for presence of contaminant cells and blood. The aspirate will be graded based on presence of blood and other contaminants.


Estimated Enrollment: 128
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
EUS FNA
Patients undergoing endoscopic ultrasound for solid mass lesions with a 22 G needle at University of Minnesota Medical center and Aurora St.Luke's Medical Center, Milwaukee, WI

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All patients undergoing endoscopic ultrasound examination of solid lesions in the mediastinum, pancreas and abdomen requiring fine needle aspiration are recruited.

Criteria

Inclusion Criteria:

  • Solid mass lesions under going endoscopic ultrasound (EUS)

Exclusion Criteria:

  • Coagulopathy
  • Age below 18 years
  • Cystic or solid-cystic lesions.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720745

Locations
United States, Minnesota
University of Minnesota Medical Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: RAJEEV ATTAM, MD    612-625-8999    attam001@umn.edu   
Principal Investigator: RAJEEV ATTAM, MD         
United States, Wisconsin
Aurora St.Luke's Medical Center Completed
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: RAJEEV ATTAM, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01720745     History of Changes
Other Study ID Numbers: RA123
Study First Received: October 25, 2012
Last Updated: January 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
EUS
FNA
Wet suction
Dry suction
Solid lesions

Additional relevant MeSH terms:
Inflammation
Lymphoma
Lymphatic Diseases
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 14, 2014