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CancerNCT01720745

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

An observational study of Cancer and Infection, run by University of Minnesota at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Infection, Inflammation
How many people
128 participants
Where
2 sitesUnited States
Study dates
Oct 2012to Sep 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Solid mass lesions under going endoscopic ultrasound (EUS)

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Aurora St.Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

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

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:

Read more

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.

Read the detailed description

Endoscopic ultrasound (EUS) has become the modality of choice for imaging the gastrointestinal wall and surrounding structures. EUS is not only used for diagnostic purposes but is also useful in tissue acquisition by fine needle aspiration (FNA) thus helping in diagnosis and treatment of various lesions. EUS-FNA is being routinely used to sample various cystic and solid lesion involving the pancreas, liver, gastric wall, adrenal glands, kidney as well as lymph nodes in areas adjacent to the gastrointestinal tract.

EUS-FNA is performed by passing a needle through a working channel located within the echoendoscope. The needle passes out of the endoscope in the same plane as the ultrasound sensor, allowing the operator to visualize the path of the needle. This allows directed needle puncture of the lesion and avoidance of other structures such as blood vessels. After the needle is passed into the lesion of interest, varying degrees of suction is applied to obtain an aspirate. The needle is withdrawn from the scope channel and aspirate is pushed out of the needle either with a stylet or by using a syringe to pump air to flush out the aspirate for further cyto-pathological evaluation. The cells obtained at needle aspiration can help in differentiating benign from malignant, and also tell the origin of the tumor if malignant.

One of the advantages of EUS-FNA is that the sample can be quickly stained and processed in the procedure room and a diagnosis can be given to the endosonographer during the procedure. The cyto pathologist if unable to provide an accurate diagnosis on the site is at least able to assess the adequacy of cellularity. This optimal and in some centers 5-6 needle passes are routinely made and the cells sent to the cytopathological laboratory for further examination, preparation of cell block etc.,. The ability to make an accurate diagnosis, , is dependent on the quality of the sample obtained. Not all the centers have the capability of having an on site cytopathologist to assess the cellularity and or make a diagnosis at the bedside. Moreover if the cellularity is inadequate or if the diagnosis is uncertain, the patient has to undergo a repeat procedure resulting in increased costs, risks and also the agony of waiting for a diagnosis.

ROLE OF SUCTION IN EUS-FNA It was believed that applying suction to the needle while it is within the desired lesion, improves the quality of aspirate. However, recently there has been a trend to use less or no suction as that provides a "less bloody" specimen. The only randomized trial comparing suction to non suction techniques observed a higher sensitivity and negative predictive values for malignancy in the suction group compared with the non-suction group. In addition, bloodiness or contamination was not increased in the suction group.

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.

Keywords
EUS, FNA, Wet suction, Dry suction, Solid lesions
Medical subject headings
Neoplasms, Infections, Inflammation, Sarcoidosis, Lymphadenopathy, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01720745
Study groupRoleWhat they receive
EUS FNAPatients 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (2)
  1. Diagnostic ability of final cytopathology at cell-block

    Cell block made from the aspirate will be evaluated for ability to reach a final pathological diagnosis.

    Measured: 6 months

  2. Presence of blood and other contaminants.

    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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionSep 2014
  4. Study completionSep 2014

Why it stopped: PI no longer at University of Minnesota

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01720745
Sponsor's protocol ID
FWA00000312-6
Status last verified
Oct 2019
First submitted
25 Oct 2012
Last updated
1 Nov 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer and Infection, run by University of Minnesota at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: PI no longer at University of Minnesota). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of cellularity obtained by wet suction and conventional dry suction technique (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.

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