<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/NCT02213419</url>
  </required_header>
  <id_info>
    <org_study_id>2014-06-058-001</org_study_id>
    <nct_id>NCT02213419</nct_id>
  </id_info>
  <brief_title>Endoscopic Ultrasonography-guided Double Ethanol Lavage for Pancreatic Cysts: a Prospective Cohort Study</brief_title>
  <official_title>EUS-guided Double Ethanol Lavage for Pancreatic Cysts: a Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Due to widespread use of cross-sectional imaging modalities, pancreatic cysts are common in&#xD;
      abdominal image. These lesions encompass a wide spectrum, ranging from benign to malignant.&#xD;
      The diagnosing specific type of cystic lesion is limited in spite of recent advances of&#xD;
      diagnostic modalities. Surgical resection is generally recommended for malignant and&#xD;
      potentially malignant lesions. However, surgical resection has significant morbidity and&#xD;
      sometimes mortality. Recently, a few study of EUS-guided ethanol lavage for cystic tumors of&#xD;
      the pancreas reported that complete resolution was achieved in only one-third of patients.&#xD;
      Ethanol lavage of pancreatic cysts may be alternative method to surgical resection.&#xD;
&#xD;
      The purpose of this study is the double ethanol lavage is a safe and effective method for&#xD;
      treatment in those with the indeterminate pancreas cysts.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">August 2016</completion_date>
  <primary_completion_date type="Anticipated">August 2016</primary_completion_date>
  <phase>Phase 1</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of Subjects with Complete or Partial response of treatment</measure>
    <time_frame>1 year after final treatment</time_frame>
    <description>Complete or partial response of treatment will be defined by the presence of a treated cystic structure, and its volume and maximum diameter in cross-sectional imaging studies (CT, MR)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence rate of adverse events after treatment</measure>
    <time_frame>1 year after final treatment</time_frame>
    <description>Adverse events include pancreatitis, bleeding, perforation, any other occurrence resulting in hospitalization, medical treatment, surgery, death, or disability</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Pancreatic Mucinous-Cystic Neoplasm</condition>
  <arm_group>
    <arm_group_label>ethanol double lavage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Endoscopic ultrasonography-guided double ethanol lavage</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Endoscopic ultrasonography-guided double ethanol lavage</intervention_name>
    <description>A radial echoendoscope and a 22 gauge needle were then used for cyst fluid aspiration and ethanol lavage.&#xD;
The 80 percent volume of cyst fluid was aspirated, and the pure ethanol was injected into the collapsed cyst until the original shape was restored. After 3-5 minutes, the reaspiration of the injected ethanol was then performed. The pure ethanol was reinjected into the collapsed cyst, followed by reaspiration of maximal possible volume for 3-5 minutes.</description>
    <arm_group_label>ethanol double lavage</arm_group_label>
    <other_name>Ethanol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients age 18 and older of any gender, ethnicity and race&#xD;
&#xD;
          -  Voluntary enrollment and ability to give written informed consent&#xD;
&#xD;
          -  Capable of safely undergoing endoscopy with deep sedation or general anesthesia&#xD;
&#xD;
          -  Indeterminate cystic lesion which was diagnosed in cross-sectional image (CT and MRI)&#xD;
&#xD;
          -  Pancreatic cystic lesion having uni- or oligo-locular (defined as having 2-6 locules&#xD;
             within a cyst) and 2~4 cm in diameter&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pancreatic cystic lesions which had the typical morphology of serous cystadenomas&#xD;
             (i.e., honeycomb appearance) and pseudocysts (i.e., recent history of acute&#xD;
             pancreatitis or parenchymal changes)&#xD;
&#xD;
          -  Pancreatic cystic lesions having communication between the cystic lesion and the main&#xD;
             pancreatic duct according to endoscopic retrograde cholangiopancreatography and&#xD;
             magnetic resonance cholangiopancreatography&#xD;
&#xD;
          -  Pancreatic cystic lesions having overt evidence of carcinomas, such as peripancreatic&#xD;
             invasion&#xD;
&#xD;
          -  Patients with a bleeding tendency (prothrombin time &gt; 1.5 international normalized&#xD;
             ratio [INR] or platelet count &lt; 50,000/μL).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jong-Kyun Lee, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Gastroenterology, Samsung Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jong-Kyun Lee, M.D., Ph.D.</last_name>
    <phone>82-2-3410-3407</phone>
    <email>jongk.lee@samsung.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Samsung Medical Cencer</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jong-Kyun Lee, M.D., Ph.D.</last_name>
      <phone>81-2-3410-3409</phone>
      <email>jongk.lee@samsung.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>February 10, 2015</last_update_submitted>
  <last_update_submitted_qc>February 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 12, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cystic Tumors of the Pancreas</keyword>
  <keyword>Endoscopic Ultrasound</keyword>
  <keyword>Ethanol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Cyst</mesh_term>
    <mesh_term>Neoplasms, Cystic, Mucinous, and Serous</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ethanol</mesh_term>
  </intervention_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/NCT02213419
org study id: 2014-06-058-001
nct id: NCT02213419
lead sponsor: 
has dmc: Yes
Due to widespread use of cross-sectional imaging modalities, pancreatic cysts are common in
      abdominal image. These lesions encompass a wide spectrum, ranging from benign to malignant.
      The diagnosing specific type of cystic lesion is limited in spite of recent advances of
      diagnostic modalities. Surgical resection is generally recommended for malignant and
      potentially malignant lesions. However, surgical resection has significant morbidity and
      sometimes mortality. Recently, a few study of EUS-guided ethanol lavage for cystic tumors of
      the pancreas reported that complete resolution was achieved in only one-third of patients.
      Ethanol lavage of pancreatic cysts may be alternative method to surgical resection.

      The purpose of this study is the double ethanol lavage is a safe and effective method for
      treatment in those with the indeterminate pancreas cysts.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of Subjects with Complete or Partial response of treatment
time frame: 1 year after final treatment
description: Complete or partial response of treatment will be defined by the presence of a treated cystic structure, and its volume and maximum diameter in cross-sectional imaging studies (CT, MR)
measure: Incidence rate of adverse events after treatment
time frame: 1 year after final treatment
description: Adverse events include pancreatitis, bleeding, perforation, any other occurrence resulting in hospitalization, medical treatment, surgery, death, or disability
arm group label: ethanol double lavage
arm group type: Experimental
description: Endoscopic ultrasonography-guided double ethanol lavage
intervention type: Drug
intervention name: Endoscopic ultrasonography-guided double ethanol lavage
description: A radial echoendoscope and a 22 gauge needle were then used for cyst fluid aspiration and ethanol lavage.
The 80 percent volume of cyst fluid was aspirated, and the pure ethanol was injected into the collapsed cyst until the original shape was restored. After 3-5 minutes, the reaspiration of the injected ethanol was then performed. The pure ethanol was reinjected into the collapsed cyst, followed by reaspiration of maximal possible volume for 3-5 minutes.
arm group label: ethanol double lavage
other name: Ethanol
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jong-Kyun Lee, M.D., Ph.D.
role: Principal Investigator
affiliation: Division of Gastroenterology, Samsung Medical Center
last name: Jong-Kyun Lee, M.D., Ph.D.
phone: 82-2-3410-3407
email: jongk.lee@samsung.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Pancreatic Cyst
mesh term: Neoplasms, Cystic, Mucinous, and Serous
mesh term: Ethanol