Comparison of "Wet Suction" Technique to Contemporary "Dry Suction" Technique Using a 22 Gauge Needle for EUS FNA
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 Needle is now withdrawn and aspirate delivered on to a slide by using a stylet and or flushing air into the needle with a syringe.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.
|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|
- 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.
- 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.
|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)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720745
|United States, Minnesota|
|University of Minnesota Medical Center||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: RAJEEV ATTAM, MD 612-625-8999 firstname.lastname@example.org|
|Principal Investigator: RAJEEV ATTAM, MD|
|United States, Wisconsin|
|Aurora St.Luke's Medical Center||Completed|
|Milwaukee, Wisconsin, United States, 53215|
|Principal Investigator:||RAJEEV ATTAM, MD||University of Minnesota - Clinical and Translational Science Institute|