<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/NCT02971475</url>
  </required_header>
  <id_info>
    <org_study_id>20160801</org_study_id>
    <nct_id>NCT02971475</nct_id>
  </id_info>
  <brief_title>ESWL Versus ESWL and Endoscopic Treatment</brief_title>
  <official_title>Extracorporeal Shock Wave Lithotripsy Versus Extracorporeal Shock Wave Lithotripsy Combined With Endoscopic Treatment for Painful Calcified Chronic Pancreatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changhai Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Changhai Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study wants to compare ESWL alone with ESWL and endoscopic drainage of the MPD for&#xD;
      treatment of pain in chronic pancreatitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The combination mode of ESWL and ERCP is an established method of treatment of painful&#xD;
      obstructive calcified chronic pancreatitis. However, the investigators notice that patients&#xD;
      after ESWL alone in calcified CP is followed by spontaneous elimination of stone fragments&#xD;
      and pain relief. Inui reported that 40% of 555 patients spontaneous eliminate stone&#xD;
      fragments. Dumonceau found that combining systematic endoscopy with ESWL adds to the cost of&#xD;
      patient care, without improving the outcome of the pancreatic pain.&#xD;
&#xD;
      So the investigators design such a prospective and randomized controlled trial. People&#xD;
      diagnosed with uncomplicated painful chronic pancreatitis and calcifications obstructing the&#xD;
      MPD will be randomly assigned to the ESWL or endoscopy group according to a table of random&#xD;
      numbers.&#xD;
&#xD;
      ESWL will be performed in all patients using a electromagnetic lithotriptor. ESWL sessions&#xD;
      will be repeated if necessary, until stone fragmentation is obtained. Patients in the&#xD;
      endoscopy group will undergo endoscopy in 48 hours with possible stent insertion. In the ESWL&#xD;
      group, if pain continues or aggravates, endoscopic drainage of the MPD will be carried out.&#xD;
&#xD;
      Follow-up will consists of telephone interview1 after treatment and clinical examination&#xD;
      every 6 months thereafter. Data collected will include clinical presentation, ESWL,&#xD;
      endoscopic and surgical procedures, life quality. In addition, S-MRCP will be performed 6&#xD;
      months after treatment. Blood glucose, insulin, stool elastase will be taken each clinical&#xD;
      examination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Anticipated">July 2019</completion_date>
  <primary_completion_date type="Anticipated">May 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline pain score as accessed by izbichi pain score at 12 month</measure>
    <time_frame>12 months</time_frame>
    <description>Whether pain is relieved depends on the change of Izbicki pain score at the baseline and 12 months after the procedure(ERCP alone or ERCP combined with ERCP). Izbicki pain score is composed of 4 parts, that is frequency of pain attacks(daily counts for 100, several times a week counts for 75, several times a month counts for 50, several times a year counts for 25 and several times a year counts for 0), VAS(subjective evaluation of pain by patients from no pain which is 0 points to imaginative maximum of pain which is 100 points), analgesic medication(morphine consumption is 100, buprenorphine is 80, pethidine is 20, tramaldol is 15, metamizole is 3 and acetylsalicylacid is 1) and time of disease-related inability to work(permanet is 100, ≤1 month is 50, ≤1 week is 25 and no inability to work during the last year is 0). Each part counts for 100 points in all.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>exocrine function of the pancreas through determination of fecal elastase as assessed by fecal elastase kit</measure>
    <time_frame>12 months</time_frame>
    <description>Pancreatic exocrine function insufficiency(PEI) is defined as fecal elastase &lt;200 μg/g. The result wii be divided into 4 conditions, that is exocrine function normal, PEI develop, PEI resolve, PEI persist.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>clearance of pancreatic stones</measure>
    <time_frame>12 months</time_frame>
    <description>Clearance of pancreatic stone is regarded as complete when clearance rate is more than 90%, partial is regarded as 50% to 90%, the rest is unsuccessful.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>decompression rate of the pancreatic duct as the change of pancreatic duct diameter assessed by S-MRCP</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>complication rate</measure>
    <time_frame>1 months</time_frame>
    <description>Complications involve pancreatitis, hemorrhage, perforation, infection and steinstrasse.</description>
  </other_outcome>
  <other_outcome>
    <measure>endocrine function as assessed by the combination of fasting blood glucose, insulin, C peptide, glycosylated hemoglobin</measure>
    <time_frame>12 months</time_frame>
    <description>As mentioned earlier, the result of pancreatic endocrine function can also be divided into 4 parts similar to that of pancreatic exocrine function.</description>
  </other_outcome>
  <other_outcome>
    <measure>treatment-related cost from initial treatment to the end of the study(12 months)</measure>
    <time_frame>12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>life quality as assessed by SF-36 questionnaire</measure>
    <time_frame>12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>BMI in kg/m^2</measure>
    <time_frame>12 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">62</enrollment>
  <condition>Pancreatitis</condition>
  <arm_group>
    <arm_group_label>ESWL alone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group would be treated with extracorporeal shock wave lithotripsy only. Otherwise, extra endoscopic procedures will be carried out in case of continuous and aggravated pain. Analgesics will be administrated as needed and recorded.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ESWL combined with ERCP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>People in this group would be treated with ESWL followed be endoscopic drainage of the main pancreatic duct in 48 hours. Analgesics will be administrated as needed and recorded.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>extracorporeal shock wave lithotripsy</intervention_name>
    <description>People in this group would be treated with ESWL only.</description>
    <arm_group_label>ESWL alone</arm_group_label>
    <other_name>ESWL</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>endoscopic drainage of the main pancreatic duct</intervention_name>
    <description>People in this group would be treated with ESWL followed be endoscopic drainage in 48 hours.</description>
    <arm_group_label>ESWL combined with ERCP</arm_group_label>
    <other_name>ERCP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Analgesics</intervention_name>
    <description>Analgesics administrated include morphine, buprenorphine, pethidine, tramaldol, metamizole and acetylsalicylacid. They will only be administrated as needed.</description>
    <arm_group_label>ESWL alone</arm_group_label>
    <arm_group_label>ESWL combined with ERCP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  painful chronic pancreatitis(abdominal pain attack during the preceding 12 months);&#xD;
&#xD;
          -  at least 1 calcified stone greater than 5 mm in one of its axes in the cephalic or&#xD;
             corporeal portion of the main pancreatic duct with upstream duct dilation;&#xD;
&#xD;
          -  no ERCP or ESWL carried out before admission&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  suspected to have malignant tumors;&#xD;
&#xD;
          -  history of pancreatic surgery or gastrojejunostomy (Billroth II);&#xD;
&#xD;
          -  pancreatic collection greater than 2 cm in diameter at magnetic resonance or CT scan;&#xD;
&#xD;
          -  age below 18 years;&#xD;
&#xD;
          -  pregnancy or lactation;&#xD;
&#xD;
          -  refuse to write informed consent&#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_contact>
    <last_name>Zhao-shen Li</last_name>
    <email>zhaoshen-li@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhuan Liao</last_name>
    <email>liaozhuan@smmu.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Changhai Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yang-Yang Qian, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanghai Changhai Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhao-shen Li</last_name>
      <email>zhaoshen-li@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Zhuan Liao</last_name>
      <email>liaozhuan@smmu.edu.cn</email>
    </contact_backup>
    <investigator>
      <last_name>Liang-hao Hu</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yang-yang Qian</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 5, 2016</study_first_submitted>
  <study_first_submitted_qc>November 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>May 30, 2018</last_update_submitted>
  <last_update_submitted_qc>May 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Changhai Hospital</investigator_affiliation>
    <investigator_full_name>Zhuan Liao</investigator_full_name>
    <investigator_title>Deputy Director</investigator_title>
  </responsible_party>
  <keyword>Extracorporeal Shock Wave lithotripsy(ESWL)</keyword>
  <keyword>Endoscopic Retrograde Cholangiopancreatography(ERCP)</keyword>
  <keyword>chronic pancreatitis</keyword>
  <keyword>pain relief</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Analgesics</mesh_term>
  </intervention_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/NCT02971475
org study id: 20160801
nct id: NCT02971475
lead sponsor: 
has dmc: Yes
The study wants to compare ESWL alone with ESWL and endoscopic drainage of the MPD for
      treatment of pain in chronic pancreatitis.
The combination mode of ESWL and ERCP is an established method of treatment of painful
      obstructive calcified chronic pancreatitis. However, the investigators notice that patients
      after ESWL alone in calcified CP is followed by spontaneous elimination of stone fragments
      and pain relief. Inui reported that 40% of 555 patients spontaneous eliminate stone
      fragments. Dumonceau found that combining systematic endoscopy with ESWL adds to the cost of
      patient care, without improving the outcome of the pancreatic pain.

      So the investigators design such a prospective and randomized controlled trial. People
      diagnosed with uncomplicated painful chronic pancreatitis and calcifications obstructing the
      MPD will be randomly assigned to the ESWL or endoscopy group according to a table of random
      numbers.

      ESWL will be performed in all patients using a electromagnetic lithotriptor. ESWL sessions
      will be repeated if necessary, until stone fragmentation is obtained. Patients in the
      endoscopy group will undergo endoscopy in 48 hours with possible stent insertion. In the ESWL
      group, if pain continues or aggravates, endoscopic drainage of the MPD will be carried out.

      Follow-up will consists of telephone interview1 after treatment and clinical examination
      every 6 months thereafter. Data collected will include clinical presentation, ESWL,
      endoscopic and surgical procedures, life quality. In addition, S-MRCP will be performed 6
      months after treatment. Blood glucose, insulin, stool elastase will be taken each clinical
      examination.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline pain score as accessed by izbichi pain score at 12 month
time frame: 12 months
description: Whether pain is relieved depends on the change of Izbicki pain score at the baseline and 12 months after the procedure(ERCP alone or ERCP combined with ERCP). Izbicki pain score is composed of 4 parts, that is frequency of pain attacks(daily counts for 100, several times a week counts for 75, several times a month counts for 50, several times a year counts for 25 and several times a year counts for 0), VAS(subjective evaluation of pain by patients from no pain which is 0 points to imaginative maximum of pain which is 100 points), analgesic medication(morphine consumption is 100, buprenorphine is 80, pethidine is 20, tramaldol is 15, metamizole is 3 and acetylsalicylacid is 1) and time of disease-related inability to work(permanet is 100, ≤1 month is 50, ≤1 week is 25 and no inability to work during the last year is 0). Each part counts for 100 points in all.
measure: exocrine function of the pancreas through determination of fecal elastase as assessed by fecal elastase kit
time frame: 12 months
description: Pancreatic exocrine function insufficiency(PEI) is defined as fecal elastase <200 μg/g. The result wii be divided into 4 conditions, that is exocrine function normal, PEI develop, PEI resolve, PEI persist.
measure: clearance of pancreatic stones
time frame: 12 months
description: Clearance of pancreatic stone is regarded as complete when clearance rate is more than 90%, partial is regarded as 50% to 90%, the rest is unsuccessful.
measure: decompression rate of the pancreatic duct as the change of pancreatic duct diameter assessed by S-MRCP
time frame: 12 months
measure: complication rate
time frame: 1 months
description: Complications involve pancreatitis, hemorrhage, perforation, infection and steinstrasse.
measure: endocrine function as assessed by the combination of fasting blood glucose, insulin, C peptide, glycosylated hemoglobin
time frame: 12 months
description: As mentioned earlier, the result of pancreatic endocrine function can also be divided into 4 parts similar to that of pancreatic exocrine function.
measure: treatment-related cost from initial treatment to the end of the study(12 months)
time frame: 12 months
measure: life quality as assessed by SF-36 questionnaire
time frame: 12 months
measure: BMI in kg/m^2
time frame: 12 months
arm group label: ESWL alone
arm group type: Experimental
description: Patients in this group would be treated with extracorporeal shock wave lithotripsy only. Otherwise, extra endoscopic procedures will be carried out in case of continuous and aggravated pain. Analgesics will be administrated as needed and recorded.
arm group label: ESWL combined with ERCP
arm group type: Active Comparator
description: People in this group would be treated with ESWL followed be endoscopic drainage of the main pancreatic duct in 48 hours. Analgesics will be administrated as needed and recorded.
intervention type: Procedure
intervention name: extracorporeal shock wave lithotripsy
description: People in this group would be treated with ESWL only.
arm group label: ESWL alone
other name: ESWL
intervention type: Procedure
intervention name: endoscopic drainage of the main pancreatic duct
description: People in this group would be treated with ESWL followed be endoscopic drainage in 48 hours.
arm group label: ESWL combined with ERCP
other name: ERCP
intervention type: Drug
intervention name: Analgesics
description: Analgesics administrated include morphine, buprenorphine, pethidine, tramaldol, metamizole and acetylsalicylacid. They will only be administrated as needed.
arm group label: ESWL alone
arm group label: ESWL combined with ERCP
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zhao-shen Li
email: zhaoshen-li@hotmail.com
last name: Zhuan Liao
email: liaozhuan@smmu.edu.cn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Changhai Hospital
investigator full name: Zhuan Liao
investigator title: Deputy Director
mesh term: Pancreatitis
mesh term: Analgesics
sharing ipd: No