<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/NCT01717196</url>
  </required_header>
  <id_info>
    <org_study_id>EX0001</org_study_id>
    <nct_id>NCT01717196</nct_id>
  </id_info>
  <brief_title>Diagnostic Accuracy of FNA: is Aspiration- Related?</brief_title>
  <acronym>expect fna</acronym>
  <official_title>Diagnostic Accuracy of FNA (Fine Needle Aspiration) on Solid Pancreatic Lesions: is Aspiration- Related?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Mediterranean Institute for Transplantation and Advanced Specialized Therapies</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Mediterranean Institute for Transplantation and Advanced Specialized Therapies</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      BACKGROUND: EUS-FNA has a central role in the diagnostic algorithm of solid pancreatic&#xD;
      masses. Different needle diameters and the use of stylet are not associated with differences&#xD;
      in terms of diagnostic yield for malignancy. Preliminary studies showed that using suction&#xD;
      (10ml) is associated with a higher sensitivity for cancer diagnosis. We aim to compare&#xD;
      EUS-FNA in the same solid pancreatic mass performed with the 22 gauge needle with different&#xD;
      aspiration volumes (10, 20, 0ml), looking for adequacy, diagnostic accuracy and&#xD;
      complications.&#xD;
&#xD;
      METHODS: Prospective clinical study at four referral Centers: ISMETT Palermo;&#xD;
      Bellaria-Maggiore, Bologna; Civico-A.R.N.A.S, Palermo; Humanitas-IRCCS, Rozzano. EUS was&#xD;
      performed by five experienced echo-endoscopist. The needle system was in all cases the 22&#xD;
      gauge EUS-FNA(Expect). We performed three punctures with a 22 G needle with both volume&#xD;
      aspiration 10 and 20 cc and without syringe for each lesion. The sequence (10cc, 20cc, no&#xD;
      aspiration) was randomly assigned by sealed envelope system. For each pass tissue samples&#xD;
      were smeared into slides for ROSE(Rapid-On-Site-Evaluation); after smearing sample into the&#xD;
      slides, the material was fixed in formalin for cyto-histological evaluation. The&#xD;
      cyto-pathologist was always blinded as to which aspiration was used for which specimen. After&#xD;
      EUS-FNA the patients were monitored for at least six hour to detect immediately&#xD;
      post-procedural complication and were followed up during the 30 days post-procedure in order&#xD;
      to detect late complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background&#xD;
&#xD;
      EUS-FNA has a central role in the diagnostic algorithm of solid pancreatic masses [ASGE&#xD;
      Practice Committee] with high sensitivity and specificity (75-92% - 82-100%), [1-2-3] and low&#xD;
      complication rate (1-2%) [4-5-6]. In the clinical setting of solid pancreatic mass a&#xD;
      histological diagnosis appears highly relevant both for differential diagnosis&#xD;
      (adenocarcinoma, lymphoma or neuroendocrine tumour) and for optimal therapeutic decision. For&#xD;
      the cythopathologic diagnosis of pancreatic cancer, sensitivity increased with the operator's&#xD;
      experience and reached 80% after 20 to 30 EUS-FNA. Furthermore it well demonstrated that&#xD;
      on-site cytopathology interpretation during the procedure increase the diagnostic yield of&#xD;
      EUS-FNA [7-8]. ROSE (Rapid On -Site Evaluation) may be useful to guide the number of FNA&#xD;
      passes, learn which parts of the lesion may be targeted for increased diagnostic yield, and&#xD;
      correct technical errors (e. g. bloody or paucicellular material) [9, 10]. The diagnostic&#xD;
      yield of EUS-guided biopsies depends on size, location and characteristics of target tissues&#xD;
      as well as on technical and procedural factors (type of needle, biopsy technique and material&#xD;
      processing) [11-20].&#xD;
&#xD;
      Expertise and training of endosonographer and interaction with the cytopathologist have also&#xD;
      an important role [7-14-15]. Up to now three different sizes of needle are available for&#xD;
      collecting cytological material: 25 - 22 and 19 gauge with an aspiration volume syringe of&#xD;
      10ml. Most of the studies on EUS-FNA have been conducted using 22G needles. Data on thinner&#xD;
      (25G) or larger (19G) needles are limited. A number of recent studies, including two RCTs,&#xD;
      compared results obtained with needles of various diameters. All these studies were performed&#xD;
      in the setting of pancreatic masses [18-20]. Although thinner needles provide less cellular&#xD;
      material than do larger needles, the specimens from the former are less contaminated by&#xD;
      blood, and thus easier to interpret. In addition, thinner needles may be easier to use&#xD;
      because of greater flexibility, particularly for locations requiring important scope bending&#xD;
      [18, 19]. An RCT in 131 patients found no significant differences between 22G and 25G needles&#xD;
      in terms of diagnostic yield for malignancy [17]. Finally another RCT compared EUS-FNA&#xD;
      without ROSE using 19G or 22G needles in 117 patients [18] showed a similar diagnostic&#xD;
      accuracy for both needles.&#xD;
&#xD;
      If the diameter of the needle used does not appear to affect the diagnostic accuracy of FNA&#xD;
      on solid pancreatic lesions, preliminary studies show that using suction during EUS FNA of&#xD;
      solid masses is associated with a significantly higher sensitivity for cancer diagnosis (86%&#xD;
      vs. 67%; P=0.05) [20]. A pilot trial suggested that applying continuous high pressure suction&#xD;
      (using a balloon inflation device) allowed retrieval of tissue samples for histopathological&#xD;
      examination in most cases [21].&#xD;
&#xD;
      A new needle Expect by Boston Scientific are available with an aspiration syringe with&#xD;
      variable volume of 5-10-15-20cc. No studies were performed comparing the diagnostic yield of&#xD;
      FNA on solid pancreatic masses performed with different aspiration volume (10 and 20ml) and&#xD;
      without aspiration.&#xD;
&#xD;
      Aims&#xD;
&#xD;
      The aims of our prospective study are to compare EUS-FNA in the same solid pancreatic mass&#xD;
      performed with the 22 gauge needle with aspiration volume syringe of 10ml, 20ml and without&#xD;
      aspiration, looking for: sample adequacy, diagnostic accuracy, complications.&#xD;
&#xD;
      Methods&#xD;
&#xD;
      Patients This was a prospective clinical study at four referral center for EUS: ISMETT/UPMC&#xD;
      (Mediterranean Institute for Transplantation and Advanced Specialized Therapies/University of&#xD;
      Pittsburgh Medical Center in Italy), Palermo; AUSL Bologna, Bellaria-Maggiore Hospital;&#xD;
      Civico-A.R.N.A.S. Hospital, Palermo; Humanitas IRCCS, Rozzano, Milano. We planned to collect&#xD;
      at least 100 cases in 3 months. The study protocol conforms to the ethical guidelines of the&#xD;
      1975 Declaration of Helsinki (6th revision, 2008) as reflected in a priori approval by the&#xD;
      institution's human research committees.&#xD;
&#xD;
      The inclusion criteria for the study were: diagnosed or suspected solid pancreatic lesions&#xD;
      according to imaging (CT-scan or/and MRI); no contraindications for FNA (see exclusion&#xD;
      criteria). The exclusion criteria were: age &lt; 18 years; cystic pancreatic lesions; history of&#xD;
      previous gastrectomy; patients hemodynamically unstable or with severe coagulopathy&#xD;
      (international normalized ratio [INR] &gt; 1.5 or platelet count &lt; 60.000 cells/cubic millimetre&#xD;
      [cmm3]); patients unable to suspend anticoagulant therapy; pregnancy; inability to give&#xD;
      informed consent; refusal to participate to the study.&#xD;
&#xD;
      Data on comorbidity and chronic treatment were recorded as well as data on possible&#xD;
      complications related to the procedure. Patients undergoing anticoagulant or antiaggregant&#xD;
      therapy for noncritical problems discontinued the treatment at least 5 days before the&#xD;
      endoscopic procedure or until INR normalization, starting low dose heparin. Written informed&#xD;
      consent was obtained from all patients for the procedures performed. All procedures were&#xD;
      performed under conscious sedation with meperidine ± midazolam or deep sedation with propofol&#xD;
      according to each center guideline and patient clinical condition.&#xD;
&#xD;
      Procedure Endoscopic ultrasonography was performed using a linear echo-endoscope by five&#xD;
      experienced echo-endoscopist with a current case volume of at list 500 per year (200 FNA).&#xD;
      The standard technique for FNA was adopted: the needle is advanced under real-time EUS&#xD;
      guidance into the target lesion by using a quick, strong thrust of the handle. The stylet is&#xD;
      completely withdrawn and a syringe attached to the end of the needle device. Once inside the&#xD;
      lesion, after applying negative pressure suction by opening the lock device of the syringe,&#xD;
      the needle is moved back and forth 15 times under EUS guidance. The suction syringe is then&#xD;
      released, the needle withdrawn into the catheter, and the whole system removed from the&#xD;
      echoendoscope.&#xD;
&#xD;
      The needle system was in all cases the 22 gauge EUS-FNA (Expect needle). After the puncture&#xD;
      the stylet was removed, and we performed three punctures with a 22 G needle with both volume&#xD;
      aspiration 10 and 20 cc and without syringe for each lesion. The sequence (10cc, 20cc, no&#xD;
      aspiration) was randomly assigned by sealed envelope system.&#xD;
&#xD;
      Technical success was defined as puncturing the target tissue properly without technical&#xD;
      difficulties (inability of the needle to exit from the channel of the scope) or mechanical&#xD;
      rupture and obtaining some visible tissue specimens or fragments with each puncture.&#xD;
&#xD;
      Tissue samples was immediately smeared into slides after each puncture, fixed and all the&#xD;
      prepared slides will be viewed by experienced pathologists for ROSE (Rapid On Site&#xD;
      Evaluation). For each pass, after smearing sample into the slides, the material was fixed in&#xD;
      formalin for cyto histological evaluation. The cytopathologist was always blinded as to which&#xD;
      aspiration was used for which specimen.&#xD;
&#xD;
      The cases will be stratified into 4 diagnostic categories applied for ROSE and for&#xD;
      histological evaluation:&#xD;
&#xD;
      a) Positive for malignancy, b) Suspicious for malignancy, c) Negative for malignancy, d) Non&#xD;
      diagnostic.&#xD;
&#xD;
      For each aspiration two fundamental parameters will be evaluated on slides and formalin fixed&#xD;
      sample: sample adequacy intended as overall cellularity (including normal, neoplastic,&#xD;
      non-epithelial cells) and diagnostic accuracy.&#xD;
&#xD;
      Post-procedural follow-up After EUS-FNA the patients were monitored for at least six hour to&#xD;
      detect immediately post-procedural complication and were followed up with a scheduled&#xD;
      protocol during the 30 days post-procedure in order to evaluate clinical status, blood&#xD;
      chemistry, and to detect late complications. All patients were followed up for at least 1&#xD;
      month. All adverse events were evaluated and related or not to the procedure. All data were&#xD;
      recorded electronically on excel database for the final analysis.&#xD;
&#xD;
      STATISTICAL ANALYSIS Data were analyzed using the SPSS 15 software package (SPSS Inc.,&#xD;
      Chicago, Illinois, USA). Continuous variables were summarized as means ± SD, or range, when&#xD;
      appropriate. Categorical variables were summarized as frequency and percentage. For&#xD;
      comparison of qualitative variables, a chi-squared test was calculated. For comparison of&#xD;
      quantitative variables, Students t test was used. Sensitivity, specificity, positive&#xD;
      predictive value (PPV), negative predictive value (NPV), and overall accuracy for each arm&#xD;
      was investigated. Differences were considered significant at a P value of &lt;0.05 (two-sided).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <primary_completion_date type="Actual">October 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>sample adequacy</measure>
    <time_frame>20min</time_frame>
    <description>Tissue samples was immediately smeared into slides after each puncture, fixed and all the prepared slides will be viewed by experienced pathologists for ROSE (Rapid On Site Evaluation). For each pass, after smearing sample into the slides, the material was fixed in formalin for cyto histological evaluation. The cytopathologist was always blinded as to which aspiration was used for which specimen.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>diagnostic accuracy</measure>
    <time_frame>5 days</time_frame>
    <description>For each pass, after smearing sample into the slides, the material was fixed in formalin for cyto histological evaluation. The cytopathologist was always blinded as to which aspiration was used for which specimen.&#xD;
The cases will be stratified into 4 diagnostic categories applied for ROSE and for histological evaluation:&#xD;
a) Positive for malignancy, b) Suspicious for malignancy, c) Negative for malignancy, d) Non diagnostic.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>complications</measure>
    <time_frame>up to 30 days after the procedure</time_frame>
    <description>After EUS-FNA the patients were monitored for at least six hour to detect immediately post-procedural complication and were followed up with a scheduled protocol during the 30 days post-procedure in order to evaluate clinical status, blood chemistry, and to detect late complications. All patients were followed up for at least 1 month. All adverse events were evaluated and related or not to the procedure.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>PANCREATIC CANCER</condition>
  <arm_group>
    <arm_group_label>DIFFERENT VOLUME ASPIRATION BIOPSY</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The needle system was in all cases the 22 gauge EUS-FNA (Expect needle). After the puncture the stylet was removed, and we performed three punctures with a 22 G needle with both volume aspiration 10 and 20 cc and without syringe for each lesion. The sequence of different volume aspiration Biopsy/ FNA (10cc, 20cc, no aspiration) was randomly assigned by sealed envelope system.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>different volume aspiration</intervention_name>
    <description>comparison between diagnostic yield of FNA on solid pancreatic masses performed with different aspiration volume (10 and 20ml) and without aspiration.</description>
    <arm_group_label>DIFFERENT VOLUME ASPIRATION BIOPSY</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosed or suspected solid pancreatic lesions according to imaging (CT-scan or/and&#xD;
             MRI);&#xD;
&#xD;
          -  no contraindications for FNA (see exclusion criteria).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 18 years;&#xD;
&#xD;
          -  cystic pancreatic lesions;&#xD;
&#xD;
          -  history of previous gastrectomy;&#xD;
&#xD;
          -  patients hemodynamically unstable or with severe coagulopathy (international&#xD;
             normalized ratio [INR] &gt; 1.5 or platelet count &lt; 60.000 cells/cubic millimetre&#xD;
             [cmm3]);&#xD;
&#xD;
          -  patients unable to suspend anticoagulant therapy;&#xD;
&#xD;
          -  pregnancy;&#xD;
&#xD;
          -  inability to give informed consent;&#xD;
&#xD;
          -  refusal to participate to the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ilaria tarantino, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Mediterranean Institute for Transplantation and Advanced Specialized Therapies</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ISMETT</name>
      <address>
        <city>Palermo</city>
        <zip>90100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>October 26, 2012</last_update_submitted>
  <last_update_submitted_qc>October 26, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 30, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>sample adequacy</keyword>
  <keyword>diagnostic accuracy</keyword>
  <keyword>complications</keyword>
  <!-- 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/NCT01717196
org study id: EX0001
nct id: NCT01717196
lead sponsor: 
has dmc: Yes
BACKGROUND: EUS-FNA has a central role in the diagnostic algorithm of solid pancreatic
      masses. Different needle diameters and the use of stylet are not associated with differences
      in terms of diagnostic yield for malignancy. Preliminary studies showed that using suction
      (10ml) is associated with a higher sensitivity for cancer diagnosis. We aim to compare
      EUS-FNA in the same solid pancreatic mass performed with the 22 gauge needle with different
      aspiration volumes (10, 20, 0ml), looking for adequacy, diagnostic accuracy and
      complications.

      METHODS: Prospective clinical study at four referral Centers: ISMETT Palermo;
      Bellaria-Maggiore, Bologna; Civico-A.R.N.A.S, Palermo; Humanitas-IRCCS, Rozzano. EUS was
      performed by five experienced echo-endoscopist. The needle system was in all cases the 22
      gauge EUS-FNA(Expect). We performed three punctures with a 22 G needle with both volume
      aspiration 10 and 20 cc and without syringe for each lesion. The sequence (10cc, 20cc, no
      aspiration) was randomly assigned by sealed envelope system. For each pass tissue samples
      were smeared into slides for ROSE(Rapid-On-Site-Evaluation); after smearing sample into the
      slides, the material was fixed in formalin for cyto-histological evaluation. The
      cyto-pathologist was always blinded as to which aspiration was used for which specimen. After
      EUS-FNA the patients were monitored for at least six hour to detect immediately
      post-procedural complication and were followed up during the 30 days post-procedure in order
      to detect late complications.
Background

      EUS-FNA has a central role in the diagnostic algorithm of solid pancreatic masses [ASGE
      Practice Committee] with high sensitivity and specificity (75-92% - 82-100%), [1-2-3] and low
      complication rate (1-2%) [4-5-6]. In the clinical setting of solid pancreatic mass a
      histological diagnosis appears highly relevant both for differential diagnosis
      (adenocarcinoma, lymphoma or neuroendocrine tumour) and for optimal therapeutic decision. For
      the cythopathologic diagnosis of pancreatic cancer, sensitivity increased with the operator's
      experience and reached 80% after 20 to 30 EUS-FNA. Furthermore it well demonstrated that
      on-site cytopathology interpretation during the procedure increase the diagnostic yield of
      EUS-FNA [7-8]. ROSE (Rapid On -Site Evaluation) may be useful to guide the number of FNA
      passes, learn which parts of the lesion may be targeted for increased diagnostic yield, and
      correct technical errors (e. g. bloody or paucicellular material) [9, 10]. The diagnostic
      yield of EUS-guided biopsies depends on size, location and characteristics of target tissues
      as well as on technical and procedural factors (type of needle, biopsy technique and material
      processing) [11-20].

      Expertise and training of endosonographer and interaction with the cytopathologist have also
      an important role [7-14-15]. Up to now three different sizes of needle are available for
      collecting cytological material: 25 - 22 and 19 gauge with an aspiration volume syringe of
      10ml. Most of the studies on EUS-FNA have been conducted using 22G needles. Data on thinner
      (25G) or larger (19G) needles are limited. A number of recent studies, including two RCTs,
      compared results obtained with needles of various diameters. All these studies were performed
      in the setting of pancreatic masses [18-20]. Although thinner needles provide less cellular
      material than do larger needles, the specimens from the former are less contaminated by
      blood, and thus easier to interpret. In addition, thinner needles may be easier to use
      because of greater flexibility, particularly for locations requiring important scope bending
      [18, 19]. An RCT in 131 patients found no significant differences between 22G and 25G needles
      in terms of diagnostic yield for malignancy [17]. Finally another RCT compared EUS-FNA
      without ROSE using 19G or 22G needles in 117 patients [18] showed a similar diagnostic
      accuracy for both needles.

      If the diameter of the needle used does not appear to affect the diagnostic accuracy of FNA
      on solid pancreatic lesions, preliminary studies show that using suction during EUS FNA of
      solid masses is associated with a significantly higher sensitivity for cancer diagnosis (86%
      vs. 67%; P=0.05) [20]. A pilot trial suggested that applying continuous high pressure suction
      (using a balloon inflation device) allowed retrieval of tissue samples for histopathological
      examination in most cases [21].

      A new needle Expect by Boston Scientific are available with an aspiration syringe with
      variable volume of 5-10-15-20cc. No studies were performed comparing the diagnostic yield of
      FNA on solid pancreatic masses performed with different aspiration volume (10 and 20ml) and
      without aspiration.

      Aims

      The aims of our prospective study are to compare EUS-FNA in the same solid pancreatic mass
      performed with the 22 gauge needle with aspiration volume syringe of 10ml, 20ml and without
      aspiration, looking for: sample adequacy, diagnostic accuracy, complications.

      Methods

      Patients This was a prospective clinical study at four referral center for EUS: ISMETT/UPMC
      (Mediterranean Institute for Transplantation and Advanced Specialized Therapies/University of
      Pittsburgh Medical Center in Italy), Palermo; AUSL Bologna, Bellaria-Maggiore Hospital;
      Civico-A.R.N.A.S. Hospital, Palermo; Humanitas IRCCS, Rozzano, Milano. We planned to collect
      at least 100 cases in 3 months. The study protocol conforms to the ethical guidelines of the
      1975 Declaration of Helsinki (6th revision, 2008) as reflected in a priori approval by the
      institution's human research committees.

      The inclusion criteria for the study were: diagnosed or suspected solid pancreatic lesions
      according to imaging (CT-scan or/and MRI); no contraindications for FNA (see exclusion
      criteria). The exclusion criteria were: age < 18 years; cystic pancreatic lesions; history of
      previous gastrectomy; patients hemodynamically unstable or with severe coagulopathy
      (international normalized ratio [INR] > 1.5 or platelet count < 60.000 cells/cubic millimetre
      [cmm3]); patients unable to suspend anticoagulant therapy; pregnancy; inability to give
      informed consent; refusal to participate to the study.

      Data on comorbidity and chronic treatment were recorded as well as data on possible
      complications related to the procedure. Patients undergoing anticoagulant or antiaggregant
      therapy for noncritical problems discontinued the treatment at least 5 days before the
      endoscopic procedure or until INR normalization, starting low dose heparin. Written informed
      consent was obtained from all patients for the procedures performed. All procedures were
      performed under conscious sedation with meperidine ± midazolam or deep sedation with propofol
      according to each center guideline and patient clinical condition.

      Procedure Endoscopic ultrasonography was performed using a linear echo-endoscope by five
      experienced echo-endoscopist with a current case volume of at list 500 per year (200 FNA).
      The standard technique for FNA was adopted: the needle is advanced under real-time EUS
      guidance into the target lesion by using a quick, strong thrust of the handle. The stylet is
      completely withdrawn and a syringe attached to the end of the needle device. Once inside the
      lesion, after applying negative pressure suction by opening the lock device of the syringe,
      the needle is moved back and forth 15 times under EUS guidance. The suction syringe is then
      released, the needle withdrawn into the catheter, and the whole system removed from the
      echoendoscope.

      The needle system was in all cases the 22 gauge EUS-FNA (Expect needle). After the puncture
      the stylet was removed, and we performed three punctures with a 22 G needle with both volume
      aspiration 10 and 20 cc and without syringe for each lesion. The sequence (10cc, 20cc, no
      aspiration) was randomly assigned by sealed envelope system.

      Technical success was defined as puncturing the target tissue properly without technical
      difficulties (inability of the needle to exit from the channel of the scope) or mechanical
      rupture and obtaining some visible tissue specimens or fragments with each puncture.

      Tissue samples was immediately smeared into slides after each puncture, fixed and all the
      prepared slides will be viewed by experienced pathologists for ROSE (Rapid On Site
      Evaluation). For each pass, after smearing sample into the slides, the material was fixed in
      formalin for cyto histological evaluation. The cytopathologist was always blinded as to which
      aspiration was used for which specimen.

      The cases will be stratified into 4 diagnostic categories applied for ROSE and for
      histological evaluation:

      a) Positive for malignancy, b) Suspicious for malignancy, c) Negative for malignancy, d) Non
      diagnostic.

      For each aspiration two fundamental parameters will be evaluated on slides and formalin fixed
      sample: sample adequacy intended as overall cellularity (including normal, neoplastic,
      non-epithelial cells) and diagnostic accuracy.

      Post-procedural follow-up After EUS-FNA the patients were monitored for at least six hour to
      detect immediately post-procedural complication and were followed up with a scheduled
      protocol during the 30 days post-procedure in order to evaluate clinical status, blood
      chemistry, and to detect late complications. All patients were followed up for at least 1
      month. All adverse events were evaluated and related or not to the procedure. All data were
      recorded electronically on excel database for the final analysis.

      STATISTICAL ANALYSIS Data were analyzed using the SPSS 15 software package (SPSS Inc.,
      Chicago, Illinois, USA). Continuous variables were summarized as means ± SD, or range, when
      appropriate. Categorical variables were summarized as frequency and percentage. For
      comparison of qualitative variables, a chi-squared test was calculated. For comparison of
      quantitative variables, Students t test was used. Sensitivity, specificity, positive
      predictive value (PPV), negative predictive value (NPV), and overall accuracy for each arm
      was investigated. Differences were considered significant at a P value of <0.05 (two-sided).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: Single (Investigator)
measure: sample adequacy
time frame: 20min
description: Tissue samples was immediately smeared into slides after each puncture, fixed and all the prepared slides will be viewed by experienced pathologists for ROSE (Rapid On Site Evaluation). For each pass, after smearing sample into the slides, the material was fixed in formalin for cyto histological evaluation. The cytopathologist was always blinded as to which aspiration was used for which specimen.
measure: diagnostic accuracy
time frame: 5 days
description: For each pass, after smearing sample into the slides, the material was fixed in formalin for cyto histological evaluation. The cytopathologist was always blinded as to which aspiration was used for which specimen.
The cases will be stratified into 4 diagnostic categories applied for ROSE and for histological evaluation:
a) Positive for malignancy, b) Suspicious for malignancy, c) Negative for malignancy, d) Non diagnostic.
measure: complications
time frame: up to 30 days after the procedure
description: After EUS-FNA the patients were monitored for at least six hour to detect immediately post-procedural complication and were followed up with a scheduled protocol during the 30 days post-procedure in order to evaluate clinical status, blood chemistry, and to detect late complications. All patients were followed up for at least 1 month. All adverse events were evaluated and related or not to the procedure.
arm group label: DIFFERENT VOLUME ASPIRATION BIOPSY
arm group type: Experimental
description: The needle system was in all cases the 22 gauge EUS-FNA (Expect needle). After the puncture the stylet was removed, and we performed three punctures with a 22 G needle with both volume aspiration 10 and 20 cc and without syringe for each lesion. The sequence of different volume aspiration Biopsy/ FNA (10cc, 20cc, no aspiration) was randomly assigned by sealed envelope system.
intervention type: Other
intervention name: different volume aspiration
description: comparison between diagnostic yield of FNA on solid pancreatic masses performed with different aspiration volume (10 and 20ml) and without aspiration.
arm group label: DIFFERENT VOLUME ASPIRATION BIOPSY
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ilaria tarantino, MD
role: Principal Investigator
affiliation: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
facility: 
country: Italy
responsible party type: Sponsor