<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/NCT03829748</url>
  </required_header>
  <id_info>
    <org_study_id>RHerranz3638</org_study_id>
    <nct_id>NCT03829748</nct_id>
  </id_info>
  <brief_title>Intermittent Suction Technique in the Diagnosis of Pancreatic Solid Lesions</brief_title>
  <official_title>Intermittent Versus Continuous Suction Technique in the Diagnosis of Pancreatic Solid Lesions. A Pilot Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación de Investigación Biomédica - Hospital Universitario de La Princesa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundación de Investigación Biomédica - Hospital Universitario de La Princesa</source>
  <oversight_info>
    <has_dmc>No</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 aim of this study is to compare the diagnostic yield of intermittent versus continuous&#xD;
      suction in the diagnosis of pancreatic solid lesions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Solid lesions of the pancreas can be neoplastic or non neoplastic and it is important to&#xD;
      accurately differentiate between them because of the poor prognosis related to pancreatic&#xD;
      neoplasm. There are many types of solid pancreatic lesions: pancreatic adenocarcinoma,&#xD;
      neuroendocrine tumor, lymphoma, solid pseudopapillary neoplasm and pancreatic metastasis.&#xD;
&#xD;
      There are several diagnostic methods for the study of pancreatic solid lesions. The different&#xD;
      imaging test allow detection and characterization of those lesions, but most times an&#xD;
      anatomopathological diagnosis is needed before stablishing the most appropriate treatment.&#xD;
&#xD;
      Endoscopic Ultrasound guided fine needle aspiration (EUS-FNA) is the diagnostic method of&#xD;
      choice for the diagnosis of these lesions as it detects small lesions that sometimes cannot&#xD;
      be found in radiological imaging test, evaluates vascular invasion and the presence of liver&#xD;
      metastasis, and allows pancreatic puncture for a cytological diagnosis. EUS-FNA is the safest&#xD;
      technique for pancreatic puncture and the least related to needle track seeding.&#xD;
&#xD;
      In order to gather as much material as possible different techniques have been proposed:&#xD;
&#xD;
        -  Fanning technique and multiple pass technique: to guide the needle into different&#xD;
           regions of the target lesions with or without removing the needle out of the lesion&#xD;
           depending on wether the lesion is hard or soft.&#xD;
&#xD;
        -  Use of stylet: there are no data clearly demonstrating that the use of suction increases&#xD;
           the yield of EUS-FNA. Some authors do slow withdrawal of the stylet.&#xD;
&#xD;
        -  Size of the needle: 19 gauge, 22 gauge, 25 gauge, depending on the localization, size&#xD;
           and vascularization. There is increasing evidence that smaller needles offer at least&#xD;
           similar results in diagnostic yield compared to larger needles and are also easier to&#xD;
           manipulate.&#xD;
&#xD;
        -  Use of suction: there is conflicting evidence in this point. Several studies have&#xD;
           evaluated the use of high volume aspiration vs low volume aspiration, continous&#xD;
           aspiration vs no aspiration and suction with empty syringe vs water-filled syringe but&#xD;
           none is clearly better than other.&#xD;
&#xD;
      The investigators aim is to evaluate if the use of intermittent suction improves the&#xD;
      diagnostic yield of pancreatic lesions compared to standard (continuous) suction. Up to our&#xD;
      knowledge this method has not been yet evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 16, 2019</start_date>
  <completion_date type="Actual">March 1, 2020</completion_date>
  <primary_completion_date type="Actual">January 16, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Increase in diagnostic yield of pancreatic solid lesions</measure>
    <time_frame>Baseline</time_frame>
    <description>Percentage of increase in positive smears between intermittent and continous suction</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sample cellularity</measure>
    <time_frame>Baseline</time_frame>
    <description>Number of malignant clusters of cells on each endoscopic pass</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood contamination</measure>
    <time_frame>Baseline</time_frame>
    <description>Percentage of blood contamination of the slides</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of passes to reach diagnosis</measure>
    <time_frame>Baseline</time_frame>
    <description>Number of passes needed to achieve a positive cytological diagnosis</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Pancreatic Cancer</condition>
  <condition>Pancreatic Neoplasms</condition>
  <arm_group>
    <arm_group_label>Intermittent aspiration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Empty syringe of 10cc and intermittent aspiration during puncture</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Continous/standard aspiration</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Empty syringe of 10cc and continous aspiration during puncture</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intermittent aspiration</intervention_name>
    <description>Endoscopic ultrasound is done for the localization of the lesion and to localize the site of puncture.Prior to the puncture of the lesion the stylet is removed and a vacuum syringe is prepared with 10 cc of vacuum allowing the generation of continous pressure inside and connected to the end of the needle. Once the lesion is punctured 15 movements in and out of the lesions will be made while the syringe is opened and closed on and off for a total of 3 times each pass. A total of 4 passes will be done in each lesion.</description>
    <arm_group_label>Intermittent aspiration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pancreatic solid lesion&#xD;
&#xD;
          -  Patients over 18 years old&#xD;
&#xD;
          -  Suitable for endoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication for endoscopy&#xD;
&#xD;
          -  Active anticoagulant therapy&#xD;
&#xD;
          -  Thrombocytopenia or coagulopathy in the absence of its correction prior to the&#xD;
             procedure&#xD;
&#xD;
          -  Absence of informed consent&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Not accessible lesion for endoscopic ultrasound puncture&#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>Herranz Pérez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundación de Investigación Biomédica - Hospital Universitario de La Princesa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitario de la Princesa</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>May 21, 2020</last_update_submitted>
  <last_update_submitted_qc>May 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pancreatic adenocarcinoma</keyword>
  <keyword>Endoscopic ultrasound</keyword>
  <keyword>Fine-needle aspiration</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>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 3, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT03829748/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03829748
org study id: RHerranz3638
nct id: NCT03829748
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to compare the diagnostic yield of intermittent versus continuous
      suction in the diagnosis of pancreatic solid lesions.
Solid lesions of the pancreas can be neoplastic or non neoplastic and it is important to
      accurately differentiate between them because of the poor prognosis related to pancreatic
      neoplasm. There are many types of solid pancreatic lesions: pancreatic adenocarcinoma,
      neuroendocrine tumor, lymphoma, solid pseudopapillary neoplasm and pancreatic metastasis.

      There are several diagnostic methods for the study of pancreatic solid lesions. The different
      imaging test allow detection and characterization of those lesions, but most times an
      anatomopathological diagnosis is needed before stablishing the most appropriate treatment.

      Endoscopic Ultrasound guided fine needle aspiration (EUS-FNA) is the diagnostic method of
      choice for the diagnosis of these lesions as it detects small lesions that sometimes cannot
      be found in radiological imaging test, evaluates vascular invasion and the presence of liver
      metastasis, and allows pancreatic puncture for a cytological diagnosis. EUS-FNA is the safest
      technique for pancreatic puncture and the least related to needle track seeding.

      In order to gather as much material as possible different techniques have been proposed:

        -  Fanning technique and multiple pass technique: to guide the needle into different
           regions of the target lesions with or without removing the needle out of the lesion
           depending on wether the lesion is hard or soft.

        -  Use of stylet: there are no data clearly demonstrating that the use of suction increases
           the yield of EUS-FNA. Some authors do slow withdrawal of the stylet.

        -  Size of the needle: 19 gauge, 22 gauge, 25 gauge, depending on the localization, size
           and vascularization. There is increasing evidence that smaller needles offer at least
           similar results in diagnostic yield compared to larger needles and are also easier to
           manipulate.

        -  Use of suction: there is conflicting evidence in this point. Several studies have
           evaluated the use of high volume aspiration vs low volume aspiration, continous
           aspiration vs no aspiration and suction with empty syringe vs water-filled syringe but
           none is clearly better than other.

      The investigators aim is to evaluate if the use of intermittent suction improves the
      diagnostic yield of pancreatic lesions compared to standard (continuous) suction. Up to our
      knowledge this method has not been yet evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Increase in diagnostic yield of pancreatic solid lesions
time frame: Baseline
description: Percentage of increase in positive smears between intermittent and continous suction
measure: Sample cellularity
time frame: Baseline
description: Number of malignant clusters of cells on each endoscopic pass
measure: Blood contamination
time frame: Baseline
description: Percentage of blood contamination of the slides
measure: Number of passes to reach diagnosis
time frame: Baseline
description: Number of passes needed to achieve a positive cytological diagnosis
arm group label: Intermittent aspiration
arm group type: Experimental
description: Empty syringe of 10cc and intermittent aspiration during puncture
arm group label: Continous/standard aspiration
arm group type: No Intervention
description: Empty syringe of 10cc and continous aspiration during puncture
intervention type: Procedure
intervention name: Intermittent aspiration
description: Endoscopic ultrasound is done for the localization of the lesion and to localize the site of puncture.Prior to the puncture of the lesion the stylet is removed and a vacuum syringe is prepared with 10 cc of vacuum allowing the generation of continous pressure inside and connected to the end of the needle. Once the lesion is punctured 15 movements in and out of the lesions will be made while the syringe is opened and closed on and off for a total of 3 times each pass. A total of 4 passes will be done in each lesion.
arm group label: Intermittent aspiration
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Herranz Pérez, MD
role: Principal Investigator
affiliation: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
sharing ipd: No
provided document: 