<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/NCT02220062</url>
  </required_header>
  <id_info>
    <org_study_id>2014-02-088-005</org_study_id>
    <nct_id>NCT02220062</nct_id>
  </id_info>
  <brief_title>Randomized, Controlled Trial of Endoscopic Ultrasound-Guided Bilateral Celiac Plexus Neurolysis vs Celiac Ganglia Neurolysis to Control Pain in Inoperable Pancreatic Cancer Patients With Inadequate Pain Control by Pain Killer</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <brief_summary>
    <textblock>
      Pancreatic cancer related pain can be difficult to control, even with high doses of&#xD;
      narcotics, whose adverse effects may further impair quality of life. So EUS-CPN(endoscopic&#xD;
      ultrasound guided celiac plexus neurolysis) is well established as an effective technique for&#xD;
      controlling pain and reducing narcotic requirements in patients with pancreatic cancer.&#xD;
      Recently, celiac ganglia can be visualized and accessed by endoscopic ultrasound. So it&#xD;
      allows for direct injection into individual celiac ganglia to perform celiac ganglia&#xD;
      neurolysis. This more precise delivery of therapeutic drug will offers the potential for&#xD;
      enhanced efficacy and safety. To evaluate this hypothesis, this randomized controlled trial&#xD;
      aimed to compare the efficacy and safety of EUS-CGN(Endoscopic ultrasound guided celiac&#xD;
      ganglia neurolysis) vs. Bilateral EUS-CPN(Endoscopic ultrasound guided celiac plexus&#xD;
      neurolysis) in providing relief from pancreas cancer-related pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <primary_completion_date type="Anticipated">August 2016</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>percentage of participants with 50% decrease or less than 3 points in Pain Visual Analogue Scale (VAS)</measure>
    <time_frame>1 week after procedure</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">166</enrollment>
  <condition>Pancreatic Neoplasms</condition>
  <arm_group>
    <arm_group_label>EUS-CPN group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group that be performed by Endoscopic ultrasound guided bilateral celiac plexus neurolysis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EUS-CGN group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group that be performed by Endoscopic ultrasound guided celiac ganglia neurolysis</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>EUS-CPN</intervention_name>
    <description>After initially identifying the celiac trunk on endoscopic ultrasound, each injection of 5~10cc ethanol would be performed as bilateral injections at the celiac trunk.</description>
    <arm_group_label>EUS-CPN group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>EUS-CGN</intervention_name>
    <description>First, identify celiac ganglia. If the celiac ganglia are visualized under linear EUS, the injection of 2~3cc ethanol are applied directly into the each ganglia. If the ganglia are not identified by EUS, bilateral EUS-CPN would be performed</description>
    <arm_group_label>EUS-CGN group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. At least 19 years old age (above 70 years old age, need the consent of the legal&#xD;
             representative)&#xD;
&#xD;
          2. Inoperable pancreatic cancer patients&#xD;
&#xD;
          3. Pancreatic cancer patients with inadequate pain control by pain killer (VAS score 4&#xD;
             points or more)&#xD;
&#xD;
          4. Patient who agree to participate in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Abnormal clotting (international normalized ratio ≥1.5)&#xD;
&#xD;
          2. Reduced platelet count (≤50000/μL)&#xD;
&#xD;
          3. Use of anticoagulation agents&#xD;
&#xD;
          4. Presence of gastric and/or esophageal varices&#xD;
&#xD;
          5. Anatomical deformity due to past surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>August 18, 2014</last_update_submitted>
  <last_update_submitted_qc>August 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Jong Kyun Lee</investigator_full_name>
    <investigator_title>Professor, Department of Gastroenterology, Sungkyunkwan University School of Medicine, Samsung Medical center</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</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/NCT02220062
org study id: 2014-02-088-005
nct id: NCT02220062
lead sponsor: 
Pancreatic cancer related pain can be difficult to control, even with high doses of
      narcotics, whose adverse effects may further impair quality of life. So EUS-CPN(endoscopic
      ultrasound guided celiac plexus neurolysis) is well established as an effective technique for
      controlling pain and reducing narcotic requirements in patients with pancreatic cancer.
      Recently, celiac ganglia can be visualized and accessed by endoscopic ultrasound. So it
      allows for direct injection into individual celiac ganglia to perform celiac ganglia
      neurolysis. This more precise delivery of therapeutic drug will offers the potential for
      enhanced efficacy and safety. To evaluate this hypothesis, this randomized controlled trial
      aimed to compare the efficacy and safety of EUS-CGN(Endoscopic ultrasound guided celiac
      ganglia neurolysis) vs. Bilateral EUS-CPN(Endoscopic ultrasound guided celiac plexus
      neurolysis) in providing relief from pancreas cancer-related pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: percentage of participants with 50% decrease or less than 3 points in Pain Visual Analogue Scale (VAS)
time frame: 1 week after procedure
arm group label: EUS-CPN group
arm group type: Active Comparator
description: Group that be performed by Endoscopic ultrasound guided bilateral celiac plexus neurolysis
arm group label: EUS-CGN group
arm group type: Experimental
description: Group that be performed by Endoscopic ultrasound guided celiac ganglia neurolysis
intervention type: Procedure
intervention name: EUS-CPN
description: After initially identifying the celiac trunk on endoscopic ultrasound, each injection of 5~10cc ethanol would be performed as bilateral injections at the celiac trunk.
arm group label: EUS-CPN group
intervention type: Procedure
intervention name: EUS-CGN
description: First, identify celiac ganglia. If the celiac ganglia are visualized under linear EUS, the injection of 2~3cc ethanol are applied directly into the each ganglia. If the ganglia are not identified by EUS, bilateral EUS-CPN would be performed
arm group label: EUS-CGN group
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Jong Kyun Lee
investigator title: Professor, Department of Gastroenterology, Sungkyunkwan University School of Medicine, Samsung Medical center
mesh term: Pancreatic Neoplasms