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.
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
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.
- Conditions
- Cancer, Infection, Inflammation, Tumor, Sarcoid, Lymphadenopathy
- 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 group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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.
- First posted2 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: PI no longer at University of Minnesota
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- RAJEEV ATTAM, MD, Principal investigator, University of Minnesota
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01720745
- Acronym / sponsor ID
- FWA00000312-6
- Conditions
- Cancer, Infection, Inflammation, Tumor, Sarcoid, Lymphadenopathy
- Keywords
- EUS, FNA, Wet suction, Dry suction, Solid lesions
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI no longer at University of Minnesota
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 2 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- Solid mass lesions under going endoscopic ultrasound (EUS)
Key exclusion criteria (3 listed)
- Coagulopathy
- Age below 18 years
- Cystic or solid-cystic lesions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of cellularity obtained by wet suction and conventional dry suction technique
Time frame: 6 months
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.
2 secondary outcomes
Diagnostic ability of final cytopathology at cell-block
Time frame: 6 months
Presence of blood and other contaminants.
Time frame: 6 months
Results and safety
The study was stopped early (reason given: PI no longer at University of Minnesota). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RAJEEV ATTAM, MD principal investigator
University of Minnesota
2 sites in 1 country: see every site and its status.
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.