NCT01720745

Brief Summary

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 Needle is now withdrawn and aspirate delivered on to a slide by using a stylet and or flushing air into the needle with a syringe.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.

Trial Health

57
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Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

2 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 2, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

1.9 years

First QC Date

October 25, 2012

Last Update Submit

October 30, 2019

Conditions

CancerInfectionInflammationTumorSarcoidLymphadenopathyLymphoma

Keywords

EUSFNAWet suctionDry suctionSolid lesions

Outcome Measures

Primary Outcomes (1)

  • Quality of cellularity obtained by wet suction and conventional dry suction technique

    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.

    6 months

Secondary Outcomes (2)

  • Diagnostic ability of final cytopathology at cell-block

    6 months

  • Presence of blood and other contaminants.

    6 months

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Solid mass lesions under going endoscopic ultrasound (EUS)

You may not qualify if:

  • Coagulopathy
  • Age below 18 years
  • Cystic or solid-cystic lesions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Aurora St.Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

NeoplasmsInfectionsInflammationSarcoidosisLymphadenopathyLymphoma

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesNeoplasms by Histologic TypeImmunoproliferative Disorders

Study Officials

  • RAJEEV ATTAM, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2012

First Posted

November 2, 2012

Study Start

October 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

November 1, 2019

Record last verified: 2019-10

Locations

US(2)