<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/NCT01698190</url>
  </required_header>
  <id_info>
    <org_study_id>SBUGI-2012</org_study_id>
    <nct_id>NCT01698190</nct_id>
  </id_info>
  <brief_title>Comparing the Efficacy of Endoscopic FNA vs FNB in Diagnosing Solid Gastrointestinal Lesions</brief_title>
  <official_title>Comparing the Overall Efficacy of Endoscopic Ultrasound Fine Needle Aspiration Versus Fine Needle Biopsy in the Diagnosis of Solid Lesions: A Multicenter, Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stony Brook University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>New York Medical College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Stony Brook University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if fine needle aspiration or fine needle biopsy is&#xD;
      more efficacious and cost-effective than the other while maintaining diagnostic accuracy in&#xD;
      the setting of solid gastrointestinal lesions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      When ultrasound is used during endoscopy, we are able to visualize the structures adjacent to&#xD;
      the gastrointestinal tract in close detail. Once the mass is visualized, we use endoscopic&#xD;
      ultrasound to obtain a tissue sample, which the pathologist can examine in order to provide a&#xD;
      diagnosis.&#xD;
&#xD;
      The conventional method for obtaining a sample of tissue with endoscopic ultrasound is called&#xD;
      fine needle aspiration (FNA). This involves the insertion of a thin needle into the mass and&#xD;
      obtaining a small sample of tissue which the pathologist can examine. An alternative&#xD;
      technique is called fine needle biopsy (FNB), and involves the insertion of a thin&#xD;
      double-edged needle into the mass. This double-edged needle may potentially provide a larger&#xD;
      sample of tissue to examine.&#xD;
&#xD;
      Both of these techniques are commonly used, and both methods are equally safe. However, it is&#xD;
      not known if one of these techniques is more effective at obtaining a sample of tissue or if&#xD;
      one of these techniques is more cost-effective than the other. The purpose of this study is&#xD;
      to determine if one method is more efficacious and cost-effective than the other while&#xD;
      maintaining diagnostic accuracy. The results of this study may alter the way&#xD;
      gastroenterologists obtain tissue samples during endoscopic ultrasound, improving the utility&#xD;
      of the exam and reducing unnecessary healthcare costs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2011</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of needle passes needed to obtain a pathologic diagnosis.</measure>
    <time_frame>Within 1 week of study enrollment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic yield, defined as percentage of cases with a diagnostic biopsy sample, between FNA and FNB.</measure>
    <time_frame>By three months post-op in the pathology report</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visible core specimens obtained and its correlation to obtaining a diagnostic sample.</measure>
    <time_frame>During the intervention itself</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of adverse side effects.</measure>
    <time_frame>Three months post-op</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Pancreatic Tumor</condition>
  <condition>Gastric Tumor</condition>
  <condition>Esophageal Tumor</condition>
  <condition>Lymphadenopathy</condition>
  <condition>Duodenal Tumor</condition>
  <arm_group>
    <arm_group_label>Fine needle aspiration (FNA)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Endoscopic ultrasound guided needle tissue acquisition: Tissue acquisition using a standard FNA needle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fine needle biopsy (FNB)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Endoscopic ultrasound guided needle tissue acquisition: Tissue acquisition using a new Core needle (Procore; Fine Needle Biopsy).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic ultrasound guided needle tissue acquisition.</intervention_name>
    <description>Endoscopic ultrasound with fine needle aspiration (FNA) allows for the safe and efficacious sampling of solid lesions that are in close proximity to the gastrointestinal tract, including extraintestinal masses, subepithelial tumors, and peri-intestinal lymphadenopathy. Fine needle core biopsy (FNB) has the potential of accruing larger tissue samples during biopsies, which may make the procedure more efficacious. In our study, we are comparing the overall efficacy between these two needles which are currently both used as standard of care.</description>
    <arm_group_label>Fine needle aspiration (FNA)</arm_group_label>
    <arm_group_label>Fine needle biopsy (FNB)</arm_group_label>
    <other_name>Echotip ProCore</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consecutive adult patients who require endoscopic ultrasound and tissue sampling of&#xD;
             either a) pancreatic solid lesion, b) subepithelial solid lesion of the esophagus,&#xD;
             stomach, duodenum or rectum, c) liver lesion, or d) lymph nodes or mass lesion located&#xD;
             adjacent to the esophagus, stomach, duodenum or rectum&#xD;
&#xD;
          -  Ability to give consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to obtain informed consent&#xD;
&#xD;
          -  Pregnant patients&#xD;
&#xD;
          -  Patients under the age of 18&#xD;
&#xD;
          -  Severe cardiopulmonary disease preventing a safe EUS procedure&#xD;
&#xD;
          -  Patients unable to safely stop anti-coagulation therapy prior to EUS procedure&#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>Satish Nagula, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stony Brook University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Satish Nagula, M.D.</last_name>
    <phone>631-444-2119</phone>
    <email>satish.nagula@stonybrookmedicine.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Stony Brook University Hospital</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Satish Nagula, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>ASGE Standards of Practice Committee; Gan SI, Rajan E, Adler DG, Baron TH, Anderson MA, Cash BD, Davila RE, Dominitz JA, Harrison ME 3rd, Ikenberry SO, Lichtenstein D, Qureshi W, Shen B, Zuckerman M, Fanelli RD, Lee KK, Van Guilder T. Role of EUS. Gastrointest Endosc. 2007 Sep;66(3):425-34. doi: 10.1016/j.gie.2007.05.026. Epub 2007 Jul 23. No abstract available.</citation>
    <PMID>17643438</PMID>
  </reference>
  <reference>
    <citation>Gress FG, Hawes RH, Savides TJ, Ikenberry SO, Lehman GA. Endoscopic ultrasound-guided fine-needle aspiration biopsy using linear array and radial scanning endosonography. Gastrointest Endosc. 1997 Mar;45(3):243-50. doi: 10.1016/s0016-5107(97)70266-9.</citation>
    <PMID>9087830</PMID>
  </reference>
  <reference>
    <citation>Wiersema MJ, Vilmann P, Giovannini M, Chang KJ, Wiersema LM. Endosonography-guided fine-needle aspiration biopsy: diagnostic accuracy and complication assessment. Gastroenterology. 1997 Apr;112(4):1087-95. doi: 10.1016/s0016-5085(97)70164-1.</citation>
    <PMID>9097990</PMID>
  </reference>
  <reference>
    <citation>Iglesias-Garcia J, Dominguez-Munoz JE, Abdulkader I, Larino-Noia J, Eugenyeva E, Lozano-Leon A, Forteza-Vila J. Influence of on-site cytopathology evaluation on the diagnostic accuracy of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of solid pancreatic masses. Am J Gastroenterol. 2011 Sep;106(9):1705-10. doi: 10.1038/ajg.2011.119. Epub 2011 Apr 12.</citation>
    <PMID>21483464</PMID>
  </reference>
  <reference>
    <citation>Schwartz DA, Unni KK, Levy MJ, Clain JE, Wiersema MJ. The rate of false-positive results with EUS-guided fine-needle aspiration. Gastrointest Endosc. 2002 Dec;56(6):868-72. doi: 10.1067/mge.2002.129610.</citation>
    <PMID>12447300</PMID>
  </reference>
  <reference>
    <citation>Iglesias-Garcia J, Poley JW, Larghi A, Giovannini M, Petrone MC, Abdulkader I, Monges G, Costamagna G, Arcidiacono P, Biermann K, Rindi G, Bories E, Dogloni C, Bruno M, Dominguez-Munoz JE. Feasibility and yield of a new EUS histology needle: results from a multicenter, pooled, cohort study. Gastrointest Endosc. 2011 Jun;73(6):1189-96. doi: 10.1016/j.gie.2011.01.053. Epub 2011 Mar 21.</citation>
    <PMID>21420083</PMID>
  </reference>
  <reference>
    <citation>Camellini L, Carlinfante G, Azzolini F, Iori V, Cavina M, Sereni G, Decembrino F, Gallo C, Tamagnini I, Valli R, Piana S, Campari C, Gardini G, Sassatelli R. A randomized clinical trial comparing 22G and 25G needles in endoscopic ultrasound-guided fine-needle aspiration of solid lesions. Endoscopy. 2011 Aug;43(8):709-15. doi: 10.1055/s-0030-1256482. Epub 2011 May 24.</citation>
    <PMID>21611946</PMID>
  </reference>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>May 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>November 18, 2014</last_update_submitted>
  <last_update_submitted_qc>November 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Stomach Neoplasms</mesh_term>
    <mesh_term>Esophageal Neoplasms</mesh_term>
    <mesh_term>Lymphadenopathy</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/NCT01698190
org study id: SBUGI-2012
nct id: NCT01698190
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to determine if fine needle aspiration or fine needle biopsy is
      more efficacious and cost-effective than the other while maintaining diagnostic accuracy in
      the setting of solid gastrointestinal lesions.
When ultrasound is used during endoscopy, we are able to visualize the structures adjacent to
      the gastrointestinal tract in close detail. Once the mass is visualized, we use endoscopic
      ultrasound to obtain a tissue sample, which the pathologist can examine in order to provide a
      diagnosis.

      The conventional method for obtaining a sample of tissue with endoscopic ultrasound is called
      fine needle aspiration (FNA). This involves the insertion of a thin needle into the mass and
      obtaining a small sample of tissue which the pathologist can examine. An alternative
      technique is called fine needle biopsy (FNB), and involves the insertion of a thin
      double-edged needle into the mass. This double-edged needle may potentially provide a larger
      sample of tissue to examine.

      Both of these techniques are commonly used, and both methods are equally safe. However, it is
      not known if one of these techniques is more effective at obtaining a sample of tissue or if
      one of these techniques is more cost-effective than the other. The purpose of this study is
      to determine if one method is more efficacious and cost-effective than the other while
      maintaining diagnostic accuracy. The results of this study may alter the way
      gastroenterologists obtain tissue samples during endoscopic ultrasound, improving the utility
      of the exam and reducing unnecessary healthcare costs.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: Number of needle passes needed to obtain a pathologic diagnosis.
time frame: Within 1 week of study enrollment
measure: Diagnostic yield, defined as percentage of cases with a diagnostic biopsy sample, between FNA and FNB.
time frame: By three months post-op in the pathology report
measure: Visible core specimens obtained and its correlation to obtaining a diagnostic sample.
time frame: During the intervention itself
measure: Frequency of adverse side effects.
time frame: Three months post-op
arm group label: Fine needle aspiration (FNA)
arm group type: Active Comparator
description: Endoscopic ultrasound guided needle tissue acquisition: Tissue acquisition using a standard FNA needle
arm group label: Fine needle biopsy (FNB)
arm group type: Active Comparator
description: Endoscopic ultrasound guided needle tissue acquisition: Tissue acquisition using a new Core needle (Procore; Fine Needle Biopsy).
intervention type: Procedure
intervention name: Endoscopic ultrasound guided needle tissue acquisition.
description: Endoscopic ultrasound with fine needle aspiration (FNA) allows for the safe and efficacious sampling of solid lesions that are in close proximity to the gastrointestinal tract, including extraintestinal masses, subepithelial tumors, and peri-intestinal lymphadenopathy. Fine needle core biopsy (FNB) has the potential of accruing larger tissue samples during biopsies, which may make the procedure more efficacious. In our study, we are comparing the overall efficacy between these two needles which are currently both used as standard of care.
arm group label: Fine needle aspiration (FNA)
arm group label: Fine needle biopsy (FNB)
other name: Echotip ProCore
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Satish Nagula, MD
role: Principal Investigator
affiliation: Stony Brook University
last name: Satish Nagula, M.D.
phone: 631-444-2119
email: satish.nagula@stonybrookmedicine.edu
facility: 
status: Recruiting
investigator: 
country: United States
citation: ASGE Standards of Practice Committee; Gan SI, Rajan E, Adler DG, Baron TH, Anderson MA, Cash BD, Davila RE, Dominitz JA, Harrison ME 3rd, Ikenberry SO, Lichtenstein D, Qureshi W, Shen B, Zuckerman M, Fanelli RD, Lee KK, Van Guilder T. Role of EUS. Gastrointest Endosc. 2007 Sep;66(3):425-34. doi: 10.1016/j.gie.2007.05.026. Epub 2007 Jul 23. No abstract available.
PMID: 17643438
citation: Gress FG, Hawes RH, Savides TJ, Ikenberry SO, Lehman GA. Endoscopic ultrasound-guided fine-needle aspiration biopsy using linear array and radial scanning endosonography. Gastrointest Endosc. 1997 Mar;45(3):243-50. doi: 10.1016/s0016-5107(97)70266-9.
PMID: 9087830
citation: Wiersema MJ, Vilmann P, Giovannini M, Chang KJ, Wiersema LM. Endosonography-guided fine-needle aspiration biopsy: diagnostic accuracy and complication assessment. Gastroenterology. 1997 Apr;112(4):1087-95. doi: 10.1016/s0016-5085(97)70164-1.
PMID: 9097990
citation: Iglesias-Garcia J, Dominguez-Munoz JE, Abdulkader I, Larino-Noia J, Eugenyeva E, Lozano-Leon A, Forteza-Vila J. Influence of on-site cytopathology evaluation on the diagnostic accuracy of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of solid pancreatic masses. Am J Gastroenterol. 2011 Sep;106(9):1705-10. doi: 10.1038/ajg.2011.119. Epub 2011 Apr 12.
PMID: 21483464
citation: Schwartz DA, Unni KK, Levy MJ, Clain JE, Wiersema MJ. The rate of false-positive results with EUS-guided fine-needle aspiration. Gastrointest Endosc. 2002 Dec;56(6):868-72. doi: 10.1067/mge.2002.129610.
PMID: 12447300
citation: Iglesias-Garcia J, Poley JW, Larghi A, Giovannini M, Petrone MC, Abdulkader I, Monges G, Costamagna G, Arcidiacono P, Biermann K, Rindi G, Bories E, Dogloni C, Bruno M, Dominguez-Munoz JE. Feasibility and yield of a new EUS histology needle: results from a multicenter, pooled, cohort study. Gastrointest Endosc. 2011 Jun;73(6):1189-96. doi: 10.1016/j.gie.2011.01.053. Epub 2011 Mar 21.
PMID: 21420083
citation: Camellini L, Carlinfante G, Azzolini F, Iori V, Cavina M, Sereni G, Decembrino F, Gallo C, Tamagnini I, Valli R, Piana S, Campari C, Gardini G, Sassatelli R. A randomized clinical trial comparing 22G and 25G needles in endoscopic ultrasound-guided fine-needle aspiration of solid lesions. Endoscopy. 2011 Aug;43(8):709-15. doi: 10.1055/s-0030-1256482. Epub 2011 May 24.
PMID: 21611946
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
mesh term: Stomach Neoplasms
mesh term: Esophageal Neoplasms
mesh term: Lymphadenopathy