Comparison of "Wet Suction" Technique to Contemporary "Dry Suction" Technique Using a 22 Gauge Needle for EUS FNA
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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 Needle is now withdrawn and aspirate delivered on to a slide by using a stylet and or flushing air into the needle with a syringe.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.
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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 |
- 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 cellualrity.
- 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 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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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
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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 |
All patients undergoing endoscopic ultrasound examination of solid lesions in the mediastinum, pancreas and abdomen requiring fine needle aspiration are recruited.
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| United States, Minnesota | |
| University of Minnesota Medical Center | Not yet 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 | Not yet recruiting |
| Milwaukee, Wisconsin, United States, 53215 | |
| Contact: NALINI GUDA, MD 414-908-6500 nguda@wisc.edu | |
| Principal Investigator: Nalini Guda, MD | |
| Principal Investigator: | RAJEEV ATTAM, MD | University of Minnesota - Clinical and Translational Science Institute |
More Information
No publications provided
| Responsible Party: | Rajeev Attam MD, md, 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: | October 31, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
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EUS FNA Wet suction Dry suction Solid lesions |
Additional relevant MeSH terms:
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Inflammation Lymphoma Lymphatic Diseases Pathologic Processes Neoplasms by Histologic Type |
Neoplasms Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013