<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/NCT04490083</url>
  </required_header>
  <id_info>
    <org_study_id>CP_ESWLPainrelief</org_study_id>
    <nct_id>NCT04490083</nct_id>
  </id_info>
  <brief_title>Predictors of Pain Relief in Chronic Pancreatitis Undergoing ESWL</brief_title>
  <official_title>Predictors of Pain Relief and Stone Fragmentation in Patients Undergoing Extra Corporeal Shock Wave Lithotripsy for Chronic Pancreatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asian Institute of Gastroenterology, India</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asian Institute of Gastroenterology, India</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Extra corporeal shock wave therapy (ESWL) is recommended for pain management in patients with&#xD;
      stone formation in pancreatic duct. ESWL can cause complete stone fragmentation and removal&#xD;
      in 70% patients, associated with 85 to 90% pain relief.&#xD;
&#xD;
      Investigators aim to study, predictors pain relief in patients who undergo ESWL, to find out&#xD;
      which patients will improve and which patients won't improve in terms of pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be a single center observational study.&#xD;
&#xD;
      General information of the patient in form of duration of symptoms and duration of&#xD;
      diagnosis,exocrine and endocrine insufficiency. Imaging findings such as main pancreatic duct&#xD;
      stone,size,parenchymal calcification , ductal stricture and its location, using any&#xD;
      medications such as antioxidants and pain killers .&#xD;
&#xD;
      The pain score will be estimated by Izbicki's pain score in last 6 months. Patients will&#xD;
      receive standard of care during study period, and they won't receive any experimental&#xD;
      therapy.&#xD;
&#xD;
      After 6months of ESWL further general information of the patient any addictions, a formal&#xD;
      imaging and determining main pancreatic duct stone ,size ,calcifications and strictures and&#xD;
      also usage of any medications for decreasing pain.&#xD;
&#xD;
      Pain will be calculated by Izbick's pain score in last 6 months . Comparing pain score and&#xD;
      information investigators will evaluate predictive factors of pain relief after ESWL by&#xD;
      logistic regression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Percentage of patients having persistent pain</measure>
    <time_frame>6 months</time_frame>
    <description>Patients with persistent pain after 6 months of ESWL will be calculated</description>
  </primary_outcome>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Chronic Pancreatitis</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Extra corporeal shock wave lithotripsy</intervention_name>
    <description>ESWL will be performed with a third generation electromagnetic lithotripter (Delta Compact, Dornier Med Tech, Germany) This has both fluoroscopy and ultrasound imaging facility. Radio opaque calculi will be targeted directly while a naso pancreatic tube (NPT) was placed for all radiolucent calculi and contrast was passed through this to localize the calculi. Between 5000 and 6000 shocks were delivered per session with frequency of 90 shocks per minute. The aim will be to fragment the calculi to &lt;3 mm or demonstrate a decrease in heterogeneity or density of the calculi in the main pancreatic duct. Shocks will be delivered on consecutive days till fragmentation is achieved. If there is no fragmentation after four sessions of ESWL the procedure will be labeled as unsuccessful and patient will be advised surgery. Procedures will be performed under epidural anesthesia.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study population will be prospectively enrolled from patients with chronic pancreatitis&#xD;
        undergoing ESWL in hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic pancreatitis patients undergoing ESWL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with multiple pancreatic duct stones&#xD;
&#xD;
          -  Patients with multiple pancreatic duct strictures&#xD;
&#xD;
          -  Pancreatic head mass&#xD;
&#xD;
          -  Patients with ascites&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Patients not giving consent for participation&#xD;
&#xD;
          -  Pseudocyst&#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>Nitin Jagtap, MD, DNB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asian Institute of Gastroenterology, Hyderabad, India</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nitin Jagtap, MD, DNB</last_name>
    <phone>04023378888</phone>
    <email>docnits13@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Manu Tandan</name>
      <address>
        <city>Hyderabad</city>
        <state>Telengana</state>
        <zip>500082</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Praneeth Kumar, MD</last_name>
      <phone>914023378888</phone>
      <email>praneethkumar.chandragiri1@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Nitin Jagtap, MD, DNB</last_name>
      <phone>914023378888</phone>
      <email>docnits13@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <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/NCT04490083
org study id: CP_ESWLPainrelief
nct id: NCT04490083
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Extra corporeal shock wave therapy (ESWL) is recommended for pain management in patients with
      stone formation in pancreatic duct. ESWL can cause complete stone fragmentation and removal
      in 70% patients, associated with 85 to 90% pain relief.

      Investigators aim to study, predictors pain relief in patients who undergo ESWL, to find out
      which patients will improve and which patients won't improve in terms of pain.
The study will be a single center observational study.

      General information of the patient in form of duration of symptoms and duration of
      diagnosis,exocrine and endocrine insufficiency. Imaging findings such as main pancreatic duct
      stone,size,parenchymal calcification , ductal stricture and its location, using any
      medications such as antioxidants and pain killers .

      The pain score will be estimated by Izbicki's pain score in last 6 months. Patients will
      receive standard of care during study period, and they won't receive any experimental
      therapy.

      After 6months of ESWL further general information of the patient any addictions, a formal
      imaging and determining main pancreatic duct stone ,size ,calcifications and strictures and
      also usage of any medications for decreasing pain.

      Pain will be calculated by Izbick's pain score in last 6 months . Comparing pain score and
      information investigators will evaluate predictive factors of pain relief after ESWL by
      logistic regression.
observational model: Cohort
time perspective: Prospective
measure: Percentage of patients having persistent pain
time frame: 6 months
description: Patients with persistent pain after 6 months of ESWL will be calculated
intervention type: Procedure
intervention name: Extra corporeal shock wave lithotripsy
description: ESWL will be performed with a third generation electromagnetic lithotripter (Delta Compact, Dornier Med Tech, Germany) This has both fluoroscopy and ultrasound imaging facility. Radio opaque calculi will be targeted directly while a naso pancreatic tube (NPT) was placed for all radiolucent calculi and contrast was passed through this to localize the calculi. Between 5000 and 6000 shocks were delivered per session with frequency of 90 shocks per minute. The aim will be to fragment the calculi to <3 mm or demonstrate a decrease in heterogeneity or density of the calculi in the main pancreatic duct. Shocks will be delivered on consecutive days till fragmentation is achieved. If there is no fragmentation after four sessions of ESWL the procedure will be labeled as unsuccessful and patient will be advised surgery. Procedures will be performed under epidural anesthesia.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nitin Jagtap, MD, DNB
role: Principal Investigator
affiliation: Asian Institute of Gastroenterology, Hyderabad, India
last name: Nitin Jagtap, MD, DNB
phone: 04023378888
email: docnits13@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: India
responsible party type: Sponsor
mesh term: Pancreatitis
mesh term: Pancreatitis, Chronic
sharing ipd: No