<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/NCT04403074</url>
  </required_header>
  <id_info>
    <org_study_id>1708591420</org_study_id>
    <nct_id>NCT04403074</nct_id>
  </id_info>
  <brief_title>Endoscopic Ultrasound-Guided Celiac Plexus Neurolysis (EUS-CPN) for Chronic Pancreatitis</brief_title>
  <acronym>CPN</acronym>
  <official_title>Endoscopic Ultrasound-Guided Celiac Plexus Neurolysis (EUS-CPN) for Chronic Pancreatitis, Database Repository</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indiana University</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>
      Physicians need a tracking system for specific treatment modalities, and data to determine&#xD;
      the impact of endoscopic ultrasound pain management for patients with chronic pancreatitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic pancreatitis is extremely painful and pain management in patients with chronic&#xD;
      pancreatitis is challenging. The etiology of abdominal pain in chronic pancreatitis is&#xD;
      considered multifactorial. Current treatments for pain control primarily include narcotic &amp;&#xD;
      opioid administration; however, these medications require titration of dosage for optimal&#xD;
      pain control and are frequently followed by adverse effects such as constipation, nausea or&#xD;
      drug addiction. Currently, the FDA has imposed strict regulations regarding the amount,&#xD;
      frequency &amp; length of time patients may receive these medications. With tightly controlled&#xD;
      regulations for prescribing narcotics and opioids for chronic pain management, the epidemic&#xD;
      of street drug usage and overdose has dramatically increased. Alternatively, celiac plexus&#xD;
      block and celiac plexus neurolysis performed under EUS guidance have been employed for pain&#xD;
      control for at least 2 decades and deemed safe. Celiac plexus block refers to temporary&#xD;
      inhibition of nerves of the celiac plexus, by using a combination of steroid and numbing&#xD;
      medications injected into the celiac plexus ganglia. Celiac plexus neurolysis (CPN) refers to&#xD;
      a temporary to semi-permanent inhibition of nerves of the celiac plexus ganglia. Injection of&#xD;
      alcohol as a neurolytic agent is used in place of the steroid which causes neurolysis of the&#xD;
      celiac plexus or ganglia.&#xD;
&#xD;
      This study will focus on collecting data related to endoscopic ultrasound procedures&#xD;
      performed by Indiana University EUS physicians; specifically for the management of chronic&#xD;
      pancreatitis pain. This data will be used for research purposes to determine the clinical&#xD;
      impact of EUS-CPN management in chronic pancreatitis pain. The physicians will also be able&#xD;
      to better understand the patient's condition and disease process that may lead to improved&#xD;
      patient management.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 20, 2017</start_date>
  <completion_date type="Anticipated">October 20, 2029</completion_date>
  <primary_completion_date type="Anticipated">October 20, 2029</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Use of Pain medication</measure>
    <time_frame>Immediately post procedure &amp; weekly up to 24 weeks</time_frame>
    <description>Use of pain medication (by using morphine equivalents) for each patient will be tracked weekly for up to 24 weeks post CPN to track pain management/relief for the of patients. There should be a lessening in use of pain medication as time progesses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient's pain intensity score (numeric pain rating scale using the visual analogue scale VAS from 1-10) will be assessed weekly (via phone call follow ups) starting right after CPN and continuing for 24 weeks.</measure>
    <time_frame>Immediately post procedure and weekly up to 24 weeks</time_frame>
    <description>Compare weekly pain intensity score for pain management/relief of patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dosage of pain medication</measure>
    <time_frame>Immediately post procedure and weekly up to 24 weeks</time_frame>
    <description>Compare dose of pain medication post procedure &amp; weekly for up to 24 weeks after converting all to morphine equivalents</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">35</enrollment>
  <condition>Chronic Pancreatitis</condition>
  <arm_group>
    <arm_group_label>Chronic Pancreatitis Patients</arm_group_label>
    <description>Patients that have Chronic Pancreatitis and the current treatment with Celiac Plexus Blocks (CPB) are providing minimal relief of pain (CPB provide less than one month of pain relief). These patient will then receive a Celiac Plexus Neurolysis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Celiac Plexus Neurolysis</intervention_name>
    <description>When CPBs are not effective (less than one month of relief) then a Celiac Plexus Neurolysis may be completed to manage pain associated with Chronic Pancreatitis.</description>
    <arm_group_label>Chronic Pancreatitis Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        As long as patients fall under the inclusion criteria and do not fall under exclusions,&#xD;
        every patient can be considered. Patient must be declared safe to undergo procedure on&#xD;
        individual basis from an evaluation from head doctor on study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Referral for the treatment of pain related to chronic pancreatitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 18 years of age&#xD;
&#xD;
          -  Absence of chronic pancreatitis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mo A, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohammad Al-Haddad</last_name>
    <phone>3179440980</phone>
    <email>moalhadd@iu.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Indiana University Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohammad Al-Haddad</last_name>
      <phone>317-944-0980</phone>
      <email>moalhadd@iu.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>October 10, 2018</study_first_submitted>
  <study_first_submitted_qc>May 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>August 6, 2022</last_update_submitted>
  <last_update_submitted_qc>August 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Mohammad Al-Haddad</investigator_full_name>
    <investigator_title>Associate Professor of Medicine, Associate Clinical Director</investigator_title>
  </responsible_party>
  <keyword>Pancreatitis</keyword>
  <keyword>Indiana</keyword>
  <keyword>Block</keyword>
  <keyword>Celiac</keyword>
  <keyword>Plexus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</mesh_term>
    <mesh_term>Pancreatitis, Chronic</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/NCT04403074
org study id: 1708591420
nct id: NCT04403074
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Physicians need a tracking system for specific treatment modalities, and data to determine
      the impact of endoscopic ultrasound pain management for patients with chronic pancreatitis.
Chronic pancreatitis is extremely painful and pain management in patients with chronic
      pancreatitis is challenging. The etiology of abdominal pain in chronic pancreatitis is
      considered multifactorial. Current treatments for pain control primarily include narcotic &
      opioid administration; however, these medications require titration of dosage for optimal
      pain control and are frequently followed by adverse effects such as constipation, nausea or
      drug addiction. Currently, the FDA has imposed strict regulations regarding the amount,
      frequency & length of time patients may receive these medications. With tightly controlled
      regulations for prescribing narcotics and opioids for chronic pain management, the epidemic
      of street drug usage and overdose has dramatically increased. Alternatively, celiac plexus
      block and celiac plexus neurolysis performed under EUS guidance have been employed for pain
      control for at least 2 decades and deemed safe. Celiac plexus block refers to temporary
      inhibition of nerves of the celiac plexus, by using a combination of steroid and numbing
      medications injected into the celiac plexus ganglia. Celiac plexus neurolysis (CPN) refers to
      a temporary to semi-permanent inhibition of nerves of the celiac plexus ganglia. Injection of
      alcohol as a neurolytic agent is used in place of the steroid which causes neurolysis of the
      celiac plexus or ganglia.

      This study will focus on collecting data related to endoscopic ultrasound procedures
      performed by Indiana University EUS physicians; specifically for the management of chronic
      pancreatitis pain. This data will be used for research purposes to determine the clinical
      impact of EUS-CPN management in chronic pancreatitis pain. The physicians will also be able
      to better understand the patient's condition and disease process that may lead to improved
      patient management.
observational model: Other
time perspective: Prospective
measure: Use of Pain medication
time frame: Immediately post procedure & weekly up to 24 weeks
description: Use of pain medication (by using morphine equivalents) for each patient will be tracked weekly for up to 24 weeks post CPN to track pain management/relief for the of patients. There should be a lessening in use of pain medication as time progesses.
measure: Patient's pain intensity score (numeric pain rating scale using the visual analogue scale VAS from 1-10) will be assessed weekly (via phone call follow ups) starting right after CPN and continuing for 24 weeks.
time frame: Immediately post procedure and weekly up to 24 weeks
description: Compare weekly pain intensity score for pain management/relief of patients.
measure: Dosage of pain medication
time frame: Immediately post procedure and weekly up to 24 weeks
description: Compare dose of pain medication post procedure & weekly for up to 24 weeks after converting all to morphine equivalents
arm group label: Chronic Pancreatitis Patients
description: Patients that have Chronic Pancreatitis and the current treatment with Celiac Plexus Blocks (CPB) are providing minimal relief of pain (CPB provide less than one month of pain relief). These patient will then receive a Celiac Plexus Neurolysis.
intervention type: Procedure
intervention name: Celiac Plexus Neurolysis
description: When CPBs are not effective (less than one month of relief) then a Celiac Plexus Neurolysis may be completed to manage pain associated with Chronic Pancreatitis.
arm group label: Chronic Pancreatitis Patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mo A, MD
role: Principal Investigator
affiliation: Indiana University
last name: Mohammad Al-Haddad
phone: 3179440980
email: moalhadd@iu.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Mohammad Al-Haddad
investigator title: Associate Professor of Medicine, Associate Clinical Director
mesh term: Pancreatitis
mesh term: Pancreatitis, Chronic