<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01720745</url>
  </required_header>
  <id_info>
    <org_study_id>FWA00000312-6</org_study_id>
    <nct_id>NCT01720745</nct_id>
  </id_info>
  <brief_title>Comparison of &quot;Wet Suction&quot; Technique to Contemporary &quot;Dry Suction&quot; Technique Using a 22 Gauge Needle for EUS FNA</brief_title>
  <official_title>Comparison of &quot;Wet Suction&quot; Technique to Contemporary &quot;Dry Suction&quot; Technique Using a 22 Gauge Needle for EUS FNA of Solid Lesions. A Randomized, Prospective, Blinded, and Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      ROLE OF SUCTION IN EUS-FNA: Current suction technique involves suctioning the aspirate into&#xD;
      the needle that has an air column. The needle is not flushed with any liquid prior to passing&#xD;
      into the desired solid lesion. Suction is applied when the needle is within the lesion&#xD;
      leading to aspiration of tissue into the needle. This is the standard technique and some have&#xD;
      done with and without the stylet. There are some data that favor non use of a stylet.&#xD;
&#xD;
      WET SCTION TECHNIQUE:&#xD;
&#xD;
      Wet suction technique involves flushing the needle with 1-2 cc of saline to replace the&#xD;
      column of air with saline. The needle is now passed into the desired lesion. Suction is&#xD;
      applied at maximal strength and needle moved back and forth within the lesion to obtain as&#xD;
      aspirate. Drops of saline can be seen moving into the suction syringe as the aspirate moves&#xD;
      into the needle. Needle is now withdrawn and aspirate delivered on to a slide by using a&#xD;
      stylet and or flushing air into the needle with a syringe.&#xD;
&#xD;
      HYPOTHESIS The effect of suction for the purpose of aspirating cells and / or tissue during&#xD;
      fine needle biopsy may be significantly improved by filling the column of the needle with a&#xD;
      less compressible fluid. The volume of vacuum being pulled may be negatively impacted by the&#xD;
      expansion of air within the needle. Replacing the air with sterile saline may thus improve&#xD;
      the suction transferred to the needle tip by ensuring that the full volume of the vacuum&#xD;
      syringe is transferred to the distal tip of the needle. This effect would be most pronounced&#xD;
      in larger gauge needles which would have a larger internal volume. An additional benefit of&#xD;
      filling the needle with saline prior to aspiration is the speed of the pressure transfer. The&#xD;
      theory is that the air in the needle may absorb some of the force of the sudden application&#xD;
      of vacuum. A column of saline in the needle may increase the velocity of the pressure&#xD;
      transfer providing more tissue and less blood.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endoscopic ultrasound (EUS) has become the modality of choice for imaging the&#xD;
      gastrointestinal wall and surrounding structures. EUS is not only used for diagnostic&#xD;
      purposes but is also useful in tissue acquisition by fine needle aspiration (FNA) thus&#xD;
      helping in diagnosis and treatment of various lesions. EUS-FNA is being routinely used to&#xD;
      sample various cystic and solid lesion involving the pancreas, liver, gastric wall, adrenal&#xD;
      glands, kidney as well as lymph nodes in areas adjacent to the gastrointestinal tract.&#xD;
&#xD;
      EUS-FNA is performed by passing a needle through a working channel located within the&#xD;
      echoendoscope. The needle passes out of the endoscope in the same plane as the ultrasound&#xD;
      sensor, allowing the operator to visualize the path of the needle. This allows directed&#xD;
      needle puncture of the lesion and avoidance of other structures such as blood vessels. After&#xD;
      the needle is passed into the lesion of interest, varying degrees of suction is applied to&#xD;
      obtain an aspirate. The needle is withdrawn from the scope channel and aspirate is pushed out&#xD;
      of the needle either with a stylet or by using a syringe to pump air to flush out the&#xD;
      aspirate for further cyto-pathological evaluation. The cells obtained at needle aspiration&#xD;
      can help in differentiating benign from malignant, and also tell the origin of the tumor if&#xD;
      malignant.&#xD;
&#xD;
      One of the advantages of EUS-FNA is that the sample can be quickly stained and processed in&#xD;
      the procedure room and a diagnosis can be given to the endosonographer during the procedure.&#xD;
      The cyto pathologist if unable to provide an accurate diagnosis on the site is at least able&#xD;
      to assess the adequacy of cellularity. This optimal and in some centers 5-6 needle passes are&#xD;
      routinely made and the cells sent to the cytopathological laboratory for further examination,&#xD;
      preparation of cell block etc.,. The ability to make an accurate diagnosis, , is dependent on&#xD;
      the quality of the sample obtained. Not all the centers have the capability of having an on&#xD;
      site cytopathologist to assess the cellularity and or make a diagnosis at the bedside.&#xD;
      Moreover if the cellularity is inadequate or if the diagnosis is uncertain, the patient has&#xD;
      to undergo a repeat procedure resulting in increased costs, risks and also the agony of&#xD;
      waiting for a diagnosis.&#xD;
&#xD;
      ROLE OF SUCTION IN EUS-FNA It was believed that applying suction to the needle while it is&#xD;
      within the desired lesion, improves the quality of aspirate. However, recently there has been&#xD;
      a trend to use less or no suction as that provides a &quot;less bloody&quot; specimen. The only&#xD;
      randomized trial comparing suction to non suction techniques observed a higher sensitivity&#xD;
      and negative predictive values for malignancy in the suction group compared with the&#xD;
      non-suction group. In addition, bloodiness or contamination was not increased in the suction&#xD;
      group.&#xD;
&#xD;
      Current suction technique involves suctioning the aspirate into the needle that has an air&#xD;
      column. The needle is not flushed with any liquid prior to passing into the desired solid&#xD;
      lesion. Suction is applied when the needle is within the lesion leading to aspiration of&#xD;
      tissue into the needle. This is the standard technique and some have done with and without&#xD;
      the stylet. There are some data that favor non use of a stylet.&#xD;
&#xD;
      WET SCTION TECHNIQUE:&#xD;
&#xD;
      Wet suction technique involves flushing the needle with 1-2 cc of saline to replace the&#xD;
      column of air with saline. The needle is now passed into the desired lesion. Suction is&#xD;
      applied at maximal strength and needle moved back and forth within the lesion to obtain as&#xD;
      aspirate. Drops of saline can be seen moving into the suction syringe as the aspirate moves&#xD;
      into the needle. Needle is now withdrawn and aspirate delivered on to a slide by using a&#xD;
      stylet and or flushing air into the needle with a syringe HYPOTHESIS The effect of suction&#xD;
      for the purpose of aspirating cells and / or tissue during fine needle biopsy may be&#xD;
      significantly improved by filling the column of the needle with a less compressible fluid.&#xD;
      The volume of vacuum being pulled may be negatively impacted by the expansion of air within&#xD;
      the needle. Replacing the air with sterile saline may thus improve the suction transferred to&#xD;
      the needle tip by ensuring that the full volume of the vacuum syringe is transferred to the&#xD;
      distal tip of the needle. This effect would be most pronounced in larger gauge needles which&#xD;
      would have a larger internal volume. An additional benefit of filling the needle with saline&#xD;
      prior to aspiration is the speed of the pressure transfer. The theory is that the air in the&#xD;
      needle may absorb some of the force of the sudden application of vacuum. A column of saline&#xD;
      in the needle may increase the velocity of the pressure transfer providing more tissue and&#xD;
      less blood.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    PI no longer at University of Minnesota&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of cellularity obtained by wet suction and conventional dry suction technique</measure>
    <time_frame>6 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic ability of final cytopathology at cell-block</measure>
    <time_frame>6 months</time_frame>
    <description>Cell block made from the aspirate will be evaluated for ability to reach a final pathological diagnosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of blood and other contaminants.</measure>
    <time_frame>6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">128</enrollment>
  <condition>Cancer</condition>
  <condition>Infection</condition>
  <condition>Inflammation</condition>
  <condition>Tumor</condition>
  <condition>Sarcoid</condition>
  <condition>Lymphadenopathy</condition>
  <condition>Lymphoma</condition>
  <arm_group>
    <arm_group_label>EUS FNA</arm_group_label>
    <description>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</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All patients undergoing endoscopic ultrasound examination of solid lesions in the&#xD;
        mediastinum, pancreas and abdomen requiring fine needle aspiration are recruited.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Solid mass lesions under going endoscopic ultrasound (EUS)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Coagulopathy&#xD;
&#xD;
          -  Age below 18 years&#xD;
&#xD;
          -  Cystic or solid-cystic lesions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>RAJEEV ATTAM, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Minnesota Medical Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aurora St.Luke's Medical Center</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>October 30, 2019</last_update_submitted>
  <last_update_submitted_qc>October 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>EUS</keyword>
  <keyword>FNA</keyword>
  <keyword>Wet suction</keyword>
  <keyword>Dry suction</keyword>
  <keyword>Solid lesions</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphadenopathy</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01720745
org study id: FWA00000312-6
nct id: NCT01720745
lead sponsor: 
has dmc: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Quality of cellularity obtained by wet suction and conventional dry suction technique
time frame: 6 months
description: 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.
measure: Diagnostic ability of final cytopathology at cell-block
time frame: 6 months
description: Cell block made from the aspirate will be evaluated for ability to reach a final pathological diagnosis.
measure: Presence of blood and other contaminants.
time frame: 6 months
description: 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.
arm group label: EUS FNA
description: 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
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: RAJEEV ATTAM, MD
role: Principal Investigator
affiliation: University of Minnesota
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lymphadenopathy
mesh term: Inflammation