<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/NCT03821974</url>
  </required_header>
  <id_info>
    <org_study_id>EUS2019-001</org_study_id>
    <nct_id>NCT03821974</nct_id>
  </id_info>
  <brief_title>The Comparison of Wet Suction and Dry Suction Technique in EUS-FNA for the Outcomes in Pancreatic Solid Lesions</brief_title>
  <official_title>The Comparison of Wet Suction Technique and Dry Suction Technique in Endoscopic Ultrasound-guided Fine-needle Aspiration (EUS-FNA) for the Outcomes in Pancreatic Solid Lesions: a Prospective, Randomized Controlled, Blinded Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Third Xiangya Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Third Xiangya Hospital of Central South University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this randomized controlled trial is to evaluate whether wet suction&#xD;
      technique (WST), compared with dry suction technique (DST), shall present a better outcome&#xD;
      with regard to the diagnostic yield and specimen quality of patients with solid lesions in&#xD;
      the pancreatics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endoscopic ultrasound guided fine-needle aspiration (EUS-FNA) has become an inevitable&#xD;
      indispensable method for acquiring a pathological diagnosis in a variety of clinical&#xD;
      conditions. It has been widely used due to the high sensitivity, specificity and safety. In&#xD;
      order to improve the puncture efficiency of FNA, many domestic and oversea scholars have&#xD;
      conducted several clinical trials. Among them, there are many studies on the type of needle,&#xD;
      needle pattern, slow pull or vacuum suction, and there are only two related reports on wet&#xD;
      suction (saline) and dry suction technique. There still have many controversies in the&#xD;
      researchers about which technique is more dominant in the wet or dry suction. The wet suction&#xD;
      technique is relying on pre-flushing the needle with saline to replace the column of air with&#xD;
      fluid followed by aspiration at the proximal end, using a prefilled suction syringe with&#xD;
      saline. It has been suggested that the presence of a saline-solution column might keep the&#xD;
      needle from getting clogged while avoiding the inherent inconvenience of a metal stylet, so&#xD;
      that it can improve the quality of specimens, diminish the contamination of blood, and&#xD;
      increase the diagnostic yield and accuracy. Wet suction may become the development trend of&#xD;
      EUS-FNA in the future because the application of wet suction is expected to improve the&#xD;
      diagnostic efficiency and the quality of samples in FNA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2019</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</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>The primary outcome is defined as the overall diagnosis yield of solid lesions by EUS-FNA with each aspiration technique.</measure>
    <time_frame>20 weeks</time_frame>
    <description>The primary outcome is defined as the overall diagnosis yield of solid lesions by EUS-FNA with each aspiration technique.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The second outcome is defined as the diagnose yield of first pass of solid lesions by EUS-FNA with each aspiration technique.</measure>
    <time_frame>20 weeks</time_frame>
    <description>The second outcome is defined as the diagnose yield of first pass of solid lesions by EUS-FNA with each aspiration technique.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The third outcome is the diagnose yield in benign solid lesions by EUS-FNA with each aspiration technique.</measure>
    <time_frame>20 weeks</time_frame>
    <description>The third outcome is the diagnose yield in benign solid lesions by EUS-FNA with each aspiration technique.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The forth outcome is the diagnose yield in malignant solid lesions by EUS-FNA with each aspiration technique.</measure>
    <time_frame>20 weeks</time_frame>
    <description>The forth outcome is the diagnose yield in malignant solid lesions by EUS-FNA with each aspiration technique.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The fifth outcome is the diagnose yield in solid lesions in different parts of the pancreas by EUS-FNA with each aspiration technique.</measure>
    <time_frame>20 weeks</time_frame>
    <description>The fifth outcome is the diagnose yield in solid lesions in different parts of the pancreas by EUS-FNA with each aspiration technique.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Pancreatic Solid Lesions</condition>
  <arm_group>
    <arm_group_label>dry group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The sequence of the technique of the puncture is dry-wet-dry-wet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>wet group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The sequence of the technique of the puncture is wet-dry-wet-dry.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>wet suction technique</intervention_name>
    <description>For the wet suction technique, after removing the stylet, the needle was flushed with 2 mL of saline solution to replace the column of air with saline solution. A 10-mL suction syringe, loaded to 5ml negative pressure, was attached in a &quot;locked&quot; position to the needle after flushing the needle with saline solution. The needle is moved back and forth 20-30 times by applying negative pressure suction within the lesion. Afterwards, the needle is withdrawn from the lesion.</description>
    <arm_group_label>dry group</arm_group_label>
    <arm_group_label>wet group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>dry suction technique</intervention_name>
    <description>For the dry suction technique, after locating by EUS, the stylet was removed from the needle before performing FNA. A 10-mL syringe, loaded to 5ml negative pressure, was attached in a &quot;locked&quot; position to the needle. Suction was applied after the lesion was punctured. The needle is moved back and forth 20-30 times by applying negative pressure suction within the lesion. Afterwards, the needle is withdrawn from the lesion.</description>
    <arm_group_label>dry group</arm_group_label>
    <arm_group_label>wet group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt; 18 years, &lt; 80 years&#xD;
&#xD;
          2. female or male&#xD;
&#xD;
          3. Patients are required to undergo EUS-FNA after undergoing imaging examination (MRI,&#xD;
             CT, or ultrasonography) which identify that the pancreatic lesions are existing and&#xD;
             solid.&#xD;
&#xD;
          4. Agree to attend this study and signed informed consent letter&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. bad physical condition, including hemoglobin ≤ 8.0 g/dl, severe cardiorespiratory&#xD;
             dysfunction, and so on&#xD;
&#xD;
          2. Coagulopathy (platelet count &lt; 50,000/mm3, international normalized ratio &gt; 1.5) or&#xD;
             having taken oral anticoagulation agents such as aspirin or warfarin in the previous&#xD;
             week&#xD;
&#xD;
          3. Be rejected by anesthesia&#xD;
&#xD;
          4. Acute pancreatitis in the previous 2 weeks&#xD;
&#xD;
          5. Pregnant or lactation period&#xD;
&#xD;
          6. Psychiatric disease, drug addiction, or other reason for unreliable follow-up or&#xD;
             questionnaires&#xD;
&#xD;
          7. Don't agree to attend this study and absence of informed consent&#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>Li Tian, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Third Xiangya Hospital of Central South University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ting Tong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Third Xiangya Hospital of Central South University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The third Xiangya Hospital of central south University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>June 14, 2021</last_update_submitted>
  <last_update_submitted_qc>June 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pancreatic solid lesions</keyword>
  <keyword>wet suction technique</keyword>
  <keyword>dry suction technique</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT03821974
org study id: EUS2019-001
nct id: NCT03821974
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of this randomized controlled trial is to evaluate whether wet suction
      technique (WST), compared with dry suction technique (DST), shall present a better outcome
      with regard to the diagnostic yield and specimen quality of patients with solid lesions in
      the pancreatics.
Endoscopic ultrasound guided fine-needle aspiration (EUS-FNA) has become an inevitable
      indispensable method for acquiring a pathological diagnosis in a variety of clinical
      conditions. It has been widely used due to the high sensitivity, specificity and safety. In
      order to improve the puncture efficiency of FNA, many domestic and oversea scholars have
      conducted several clinical trials. Among them, there are many studies on the type of needle,
      needle pattern, slow pull or vacuum suction, and there are only two related reports on wet
      suction (saline) and dry suction technique. There still have many controversies in the
      researchers about which technique is more dominant in the wet or dry suction. The wet suction
      technique is relying on pre-flushing the needle with saline to replace the column of air with
      fluid followed by aspiration at the proximal end, using a prefilled suction syringe with
      saline. It has been suggested that the presence of a saline-solution column might keep the
      needle from getting clogged while avoiding the inherent inconvenience of a metal stylet, so
      that it can improve the quality of specimens, diminish the contamination of blood, and
      increase the diagnostic yield and accuracy. Wet suction may become the development trend of
      EUS-FNA in the future because the application of wet suction is expected to improve the
      diagnostic efficiency and the quality of samples in FNA.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: The primary outcome is defined as the overall diagnosis yield of solid lesions by EUS-FNA with each aspiration technique.
time frame: 20 weeks
description: The primary outcome is defined as the overall diagnosis yield of solid lesions by EUS-FNA with each aspiration technique.
measure: The second outcome is defined as the diagnose yield of first pass of solid lesions by EUS-FNA with each aspiration technique.
time frame: 20 weeks
description: The second outcome is defined as the diagnose yield of first pass of solid lesions by EUS-FNA with each aspiration technique.
measure: The third outcome is the diagnose yield in benign solid lesions by EUS-FNA with each aspiration technique.
time frame: 20 weeks
description: The third outcome is the diagnose yield in benign solid lesions by EUS-FNA with each aspiration technique.
measure: The forth outcome is the diagnose yield in malignant solid lesions by EUS-FNA with each aspiration technique.
time frame: 20 weeks
description: The forth outcome is the diagnose yield in malignant solid lesions by EUS-FNA with each aspiration technique.
measure: The fifth outcome is the diagnose yield in solid lesions in different parts of the pancreas by EUS-FNA with each aspiration technique.
time frame: 20 weeks
description: The fifth outcome is the diagnose yield in solid lesions in different parts of the pancreas by EUS-FNA with each aspiration technique.
arm group label: dry group
arm group type: Experimental
description: The sequence of the technique of the puncture is dry-wet-dry-wet.
arm group label: wet group
arm group type: Experimental
description: The sequence of the technique of the puncture is wet-dry-wet-dry.
intervention type: Procedure
intervention name: wet suction technique
description: For the wet suction technique, after removing the stylet, the needle was flushed with 2 mL of saline solution to replace the column of air with saline solution. A 10-mL suction syringe, loaded to 5ml negative pressure, was attached in a "locked" position to the needle after flushing the needle with saline solution. The needle is moved back and forth 20-30 times by applying negative pressure suction within the lesion. Afterwards, the needle is withdrawn from the lesion.
arm group label: dry group
arm group label: wet group
intervention type: Procedure
intervention name: dry suction technique
description: For the dry suction technique, after locating by EUS, the stylet was removed from the needle before performing FNA. A 10-mL syringe, loaded to 5ml negative pressure, was attached in a "locked" position to the needle. Suction was applied after the lesion was punctured. The needle is moved back and forth 20-30 times by applying negative pressure suction within the lesion. Afterwards, the needle is withdrawn from the lesion.
arm group label: dry group
arm group label: wet group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Li Tian, MD
role: Principal Investigator
affiliation: The Third Xiangya Hospital of Central South University
last name: Ting Tong, MD
role: Principal Investigator
affiliation: The Third Xiangya Hospital of Central South University
facility: 
country: China
responsible party type: Sponsor
sharing ipd: No