<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/NCT03803930</url>
  </required_header>
  <id_info>
    <org_study_id>FNB20</org_study_id>
    <nct_id>NCT03803930</nct_id>
  </id_info>
  <brief_title>Comparing of a 22G EUS Procore Fine Needle Biopsy Device and a 20G EUS Procore Fine Needle Biopsy Device</brief_title>
  <official_title>Comparing of a 22G EUS Procore Fine Needle Biopsy Device and a 20G EUS Procore Fine Needle Biopsy Device for Solid Pancreatic Lesions: a Prospective Multi-center, Randomized, and Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huazhong University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Huazhong University of Science and Technology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the diagnosis accuracy of 22G EUS Procore fine needle&#xD;
      biopsy （FNB）device and 20G EUS Procore fine needle biopsy device for solid pancreatic&#xD;
      lesions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-blind, randomized, controlled trial. One thousand two hundred and twenty&#xD;
      four patients with solid pancreatic lesions referred for EUS guided fine needle biopsy will&#xD;
      be randomly assigned to 4 arms. For arm A1 which will be used with 22G EUS Procore fine&#xD;
      needle biopsy device, the pass sequence is slow pull(SP)-modified wet suction&#xD;
      technique(MWST)-slow pull(SP)-modified wet suction technique(MWST). For arm A2 with 22G EUS&#xD;
      Procore fine needle biopsy device, the pass sequence is MWST-SP-MWST-SP. For arm B1 with 20G&#xD;
      EUS Procore fine needle biopsy device, the pass sequence is SP-MWST-SP-MWST. For arm B2 with&#xD;
      20G EUS Procore fine needle biopsy device, the pass sequence is MWST-SP-MWST-SP. All&#xD;
      procedures will be performed by experienced echoendoscopists, and the patients and assessors&#xD;
      (cytologists and pathologists) will be blinded during the entire study. The primary outcome&#xD;
      measure is the diagnosis yield. Secondary outcome measures are specimen quality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 1, 2019</start_date>
  <completion_date type="Anticipated">August 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2020</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The diagnostic yields</measure>
    <time_frame>up to 15 months</time_frame>
    <description>The investigators' primary outcome measure is to compare the diagnostic yields of 22G FNB and 20G FNB to the solid pancreatic lesions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the tissue integrity</measure>
    <time_frame>up to 15 months</time_frame>
    <description>The investigators' secondary outcome measure is to assess the tissue size under a light microscope to compare the tissue obtained by 22G FNB and 20G FNB with Slow-pull or modified wet suction technique.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">1224</enrollment>
  <condition>Pancreas Neoplasms</condition>
  <arm_group>
    <arm_group_label>Arm 22G+SP</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Using 22G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 22G+MWST</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Using 22G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 20G+SP</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Using 20G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 20G+MWST</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Using 20G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Using 22G FNB, the first pass is SP</intervention_name>
    <description>Using 22G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.</description>
    <arm_group_label>Arm 22G+SP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Using 22G FNB, the first pass is MWST</intervention_name>
    <description>Using 22G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.</description>
    <arm_group_label>Arm 22G+MWST</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Using 20G FNB, the first pass is SP</intervention_name>
    <description>Using 20G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.</description>
    <arm_group_label>Arm 20G+SP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Using 20G FNB, the first pass is MWST</intervention_name>
    <description>Using 20G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.technique-slow pull.</description>
    <arm_group_label>Arm 20G+MWST</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt;18 years old,&lt;85 years old;&#xD;
&#xD;
          2. Gender: Male or Female;&#xD;
&#xD;
          3. Presence solid occupying pancreatic lesions (the diameter&gt;1cm);&#xD;
&#xD;
          4. Must be able to receive examinations in the research center;&#xD;
&#xD;
          5. Must be able to sign the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hemoglobin≤8.0 g/dl;&#xD;
&#xD;
          2. Pregnant women;&#xD;
&#xD;
          3. Coagulation disorders;&#xD;
&#xD;
          4. Took anticoagulants such as aspirin, warfarin in the latest week;&#xD;
&#xD;
          5. Acute pancreatitis in the past two weeks;&#xD;
&#xD;
          6. Cardiopulmonary dysfunction;&#xD;
&#xD;
          7. Cannot sign the informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bin Cheng</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tongji Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bin Cheng</last_name>
    <phone>+862783663333</phone>
    <email>b.cheng@tjh.tjmu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yun Wang</last_name>
    <phone>+862783663333</phone>
    <email>820308045@qq.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Bin Cheng</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Bin Cheng, Doctor</last_name>
      <phone>2783663333</phone>
      <email>b.cheng@tjh.tjmu.edu.cn</email>
    </contact>
    <contact_backup>
      <last_name>Yun Wang, Doctor</last_name>
      <phone>+862783663333</phone>
      <email>820308045@qq.com</email>
    </contact_backup>
    <investigator>
      <last_name>Bin Cheng, Doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yun Wang, Doctor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>DeWitt J, Jowell P, Leblanc J, McHenry L, McGreevy K, Cramer H, Volmar K, Sherman S, Gress F. EUS-guided FNA of pancreatic metastases: a multicenter experience. Gastrointest Endosc. 2005 May;61(6):689-96. doi: 10.1016/s0016-5107(05)00287-7.</citation>
    <PMID>15855973</PMID>
  </results_reference>
  <results_reference>
    <citation>Bang JY, Hebert-Magee S, Trevino J, Ramesh J, Varadarajulu S. Randomized trial comparing the 22-gauge aspiration and 22-gauge biopsy needles for EUS-guided sampling of solid pancreatic mass lesions. Gastrointest Endosc. 2012 Aug;76(2):321-7. doi: 10.1016/j.gie.2012.03.1392. Epub 2012 May 31.</citation>
    <PMID>22658389</PMID>
  </results_reference>
  <results_reference>
    <citation>Ge N, Zhang S, Jin Z, Sun S, Yang A, Wang B, Wang G, Xu G, Hao J, Zhong L, Zhong N, Li P, Zhu Q, Nian W, Li W, Zhang X, Zhou X, Yang X, Cui Y, Ding Z. Clinical use of endoscopic ultrasound-guided fine-needle aspiration: Guidelines and recommendations from Chinese Society of Digestive Endoscopy. Endosc Ultrasound. 2017 Mar-Apr;6(2):75-82. doi: 10.4103/eus.eus_20_17. No abstract available.</citation>
    <PMID>28440232</PMID>
  </results_reference>
  <results_reference>
    <citation>Gleeson FC, Kipp BR, Caudill JL, Clain JE, Clayton AC, Halling KC, Henry MR, Rajan E, Topazian MD, Wang KK, Wiersema MJ, Zhang J, Levy MJ. False positive endoscopic ultrasound fine needle aspiration cytology: incidence and risk factors. Gut. 2010 May;59(5):586-93. doi: 10.1136/gut.2009.187765.</citation>
    <PMID>20427392</PMID>
  </results_reference>
  <results_reference>
    <citation>Cheng B, Zhang Y, Chen Q, Sun B, Deng Z, Shan H, Dou L, Wang J, Li Y, Yang X, Jiang T, Xu G, Wang G. Analysis of Fine-Needle Biopsy vs Fine-Needle Aspiration in Diagnosis of Pancreatic and Abdominal Masses: A Prospective, Multicenter, Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2018 Aug;16(8):1314-1321. doi: 10.1016/j.cgh.2017.07.010. Epub 2017 Jul 19.</citation>
    <PMID>28733257</PMID>
  </results_reference>
  <results_reference>
    <citation>Attam R, Arain MA, Bloechl SJ, Trikudanathan G, Munigala S, Bakman Y, Singh M, Wallace T, Henderson JB, Catalano MF, Guda NM. &quot;Wet suction technique (WEST)&quot;: a novel way to enhance the quality of EUS-FNA aspirate. Results of a prospective, single-blind, randomized, controlled trial using a 22-gauge needle for EUS-FNA of solid lesions. Gastrointest Endosc. 2015;81(6):1401-7. doi: 10.1016/j.gie.2014.11.023. Epub 2015 Feb 27.</citation>
    <PMID>25733127</PMID>
  </results_reference>
  <results_reference>
    <citation>Villa NA, Berzosa M, Wallace MB, Raijman I. Endoscopic ultrasound-guided fine needle aspiration: The wet suction technique. Endosc Ultrasound. 2016 Jan-Feb;5(1):17-20. doi: 10.4103/2303-9027.175877.</citation>
    <PMID>26879162</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 25, 2018</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 16, 2019</last_update_submitted>
  <last_update_submitted_qc>January 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Huazhong University of Science and Technology</investigator_affiliation>
    <investigator_full_name>Bin Cheng</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>EUS-FNB</keyword>
  <keyword>slow pull</keyword>
  <keyword>modified wet suction technique</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03803930
org study id: FNB20
nct id: NCT03803930
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the diagnosis accuracy of 22G EUS Procore fine needle
      biopsy （FNB）device and 20G EUS Procore fine needle biopsy device for solid pancreatic
      lesions.
This is a single-blind, randomized, controlled trial. One thousand two hundred and twenty
      four patients with solid pancreatic lesions referred for EUS guided fine needle biopsy will
      be randomly assigned to 4 arms. For arm A1 which will be used with 22G EUS Procore fine
      needle biopsy device, the pass sequence is slow pull(SP)-modified wet suction
      technique(MWST)-slow pull(SP)-modified wet suction technique(MWST). For arm A2 with 22G EUS
      Procore fine needle biopsy device, the pass sequence is MWST-SP-MWST-SP. For arm B1 with 20G
      EUS Procore fine needle biopsy device, the pass sequence is SP-MWST-SP-MWST. For arm B2 with
      20G EUS Procore fine needle biopsy device, the pass sequence is MWST-SP-MWST-SP. All
      procedures will be performed by experienced echoendoscopists, and the patients and assessors
      (cytologists and pathologists) will be blinded during the entire study. The primary outcome
      measure is the diagnosis yield. Secondary outcome measures are specimen quality.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: The diagnostic yields
time frame: up to 15 months
description: The investigators' primary outcome measure is to compare the diagnostic yields of 22G FNB and 20G FNB to the solid pancreatic lesions.
measure: the tissue integrity
time frame: up to 15 months
description: The investigators' secondary outcome measure is to assess the tissue size under a light microscope to compare the tissue obtained by 22G FNB and 20G FNB with Slow-pull or modified wet suction technique.
arm group label: Arm 22G+SP
arm group type: Other
description: Using 22G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.
arm group label: Arm 22G+MWST
arm group type: Other
description: Using 22G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.
arm group label: Arm 20G+SP
arm group type: Other
description: Using 20G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.
arm group label: Arm 20G+MWST
arm group type: Other
description: Using 20G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.
intervention type: Device
intervention name: Using 22G FNB, the first pass is SP
description: Using 22G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.
arm group label: Arm 22G+SP
intervention type: Device
intervention name: Using 22G FNB, the first pass is MWST
description: Using 22G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.
arm group label: Arm 22G+MWST
intervention type: Device
intervention name: Using 20G FNB, the first pass is SP
description: Using 20G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.
arm group label: Arm 20G+SP
intervention type: Device
intervention name: Using 20G FNB, the first pass is MWST
description: Using 20G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.technique-slow pull.
arm group label: Arm 20G+MWST
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Bin Cheng
role: Principal Investigator
affiliation: Tongji Hospital
last name: Bin Cheng
phone: +862783663333
email: b.cheng@tjh.tjmu.edu.cn
last name: Yun Wang
phone: +862783663333
email: 820308045@qq.com
facility: 
contact: 
contact backup: 
investigator: 
investigator: 
country: China
citation: DeWitt J, Jowell P, Leblanc J, McHenry L, McGreevy K, Cramer H, Volmar K, Sherman S, Gress F. EUS-guided FNA of pancreatic metastases: a multicenter experience. Gastrointest Endosc. 2005 May;61(6):689-96. doi: 10.1016/s0016-5107(05)00287-7.
PMID: 15855973
citation: Bang JY, Hebert-Magee S, Trevino J, Ramesh J, Varadarajulu S. Randomized trial comparing the 22-gauge aspiration and 22-gauge biopsy needles for EUS-guided sampling of solid pancreatic mass lesions. Gastrointest Endosc. 2012 Aug;76(2):321-7. doi: 10.1016/j.gie.2012.03.1392. Epub 2012 May 31.
PMID: 22658389
citation: Ge N, Zhang S, Jin Z, Sun S, Yang A, Wang B, Wang G, Xu G, Hao J, Zhong L, Zhong N, Li P, Zhu Q, Nian W, Li W, Zhang X, Zhou X, Yang X, Cui Y, Ding Z. Clinical use of endoscopic ultrasound-guided fine-needle aspiration: Guidelines and recommendations from Chinese Society of Digestive Endoscopy. Endosc Ultrasound. 2017 Mar-Apr;6(2):75-82. doi: 10.4103/eus.eus_20_17. No abstract available.
PMID: 28440232
citation: Gleeson FC, Kipp BR, Caudill JL, Clain JE, Clayton AC, Halling KC, Henry MR, Rajan E, Topazian MD, Wang KK, Wiersema MJ, Zhang J, Levy MJ. False positive endoscopic ultrasound fine needle aspiration cytology: incidence and risk factors. Gut. 2010 May;59(5):586-93. doi: 10.1136/gut.2009.187765.
PMID: 20427392
citation: Cheng B, Zhang Y, Chen Q, Sun B, Deng Z, Shan H, Dou L, Wang J, Li Y, Yang X, Jiang T, Xu G, Wang G. Analysis of Fine-Needle Biopsy vs Fine-Needle Aspiration in Diagnosis of Pancreatic and Abdominal Masses: A Prospective, Multicenter, Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2018 Aug;16(8):1314-1321. doi: 10.1016/j.cgh.2017.07.010. Epub 2017 Jul 19.
PMID: 28733257
citation: Attam R, Arain MA, Bloechl SJ, Trikudanathan G, Munigala S, Bakman Y, Singh M, Wallace T, Henderson JB, Catalano MF, Guda NM. "Wet suction technique (WEST)": a novel way to enhance the quality of EUS-FNA aspirate. Results of a prospective, single-blind, randomized, controlled trial using a 22-gauge needle for EUS-FNA of solid lesions. Gastrointest Endosc. 2015;81(6):1401-7. doi: 10.1016/j.gie.2014.11.023. Epub 2015 Feb 27.
PMID: 25733127
citation: Villa NA, Berzosa M, Wallace MB, Raijman I. Endoscopic ultrasound-guided fine needle aspiration: The wet suction technique. Endosc Ultrasound. 2016 Jan-Feb;5(1):17-20. doi: 10.4103/2303-9027.175877.
PMID: 26879162
responsible party type: Principal Investigator
investigator affiliation: Huazhong University of Science and Technology
investigator full name: Bin Cheng
investigator title: professor
mesh term: Pancreatic Neoplasms
sharing ipd: Undecided