<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/NCT03754491</url>
  </required_header>
  <id_info>
    <org_study_id>gimy54861439</org_study_id>
    <nct_id>NCT03754491</nct_id>
  </id_info>
  <brief_title>The Comparisons of One-stage Stone Removal in Mild and Moderate Cholangitis</brief_title>
  <acronym>ERCP</acronym>
  <official_title>Division of Hepato-gastroenterology; Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung,Taiwan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</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>
      In expert comment, performing the sphincterotomy for choledocholithiasis with acute&#xD;
      cholangitis may increase bleeding and pancreatitis risks (from 2% to 10%). Therefore,&#xD;
      investigators often perform biliary drainage in acute stage, and arrange 2nd session ERCP for&#xD;
      stone removal later. However, in the recent study, single-stage endoscopic treatment may be&#xD;
      still effective (stone removal rate 90%) and safe for mild to moderate acute cholangitis&#xD;
      associated with choledocholithiasis. Investigators will carry out a prospective trial to&#xD;
      analyze one-stage retrograde endoscopic common bile duct stone removal in mild and moderate&#xD;
      cholangitis with choledocholithiasis to determine the safety, successful rate, and&#xD;
      complications in these two groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators will enroll 204 naïve papilla with a body temperature ≥37 °C who was diagnosed&#xD;
      with mild to moderate cholangitis associated with choledocholithiasis. The method of&#xD;
      one-stage: performing the stone removal at the first session of ERCP. The pancreas duct stent&#xD;
      will be placed for preventing post ERCP pancreatitis (PEP) if necessary. The indomethacin&#xD;
      100mg anal route will be administered for all patients without allergy history. All&#xD;
      participants will receive the empiric antibiotics treatment for cholangitis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">February 14, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Investigators will enroll 204 naïve papilla with a body temperature ≥37 °C who was diagnosed with mild or moderate cholangitis associated with choledocholithiasis for one-stage procedure to remove CBD stone.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post ERCP pancreatitis</measure>
    <time_frame>After ERCP, an average of 7 days</time_frame>
    <description>Serum amylase &gt; 3 times of (115 IU/L) with clinical abdominal pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bowel perforation</measure>
    <time_frame>After ERCP, an average of 7 days</time_frame>
    <description>Participants with sign of bowel perforation after ERCP</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Papillary bleeding</measure>
    <time_frame>After ERCP, an average of 7 days</time_frame>
    <description>Participants with papillary bleeding after ERCP</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Success rate of stone removal</measure>
    <time_frame>an average of 14 days.</time_frame>
    <description>Complete bile duct stone clearance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cost of hospitalization</measure>
    <time_frame>From emergent department to the timing of being discharged, and an average of 30 days</time_frame>
    <description>Total cost in two individual groups in hospitalization.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>an average of 30 days</time_frame>
    <description>Mortality during and after discharged</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">196</enrollment>
  <condition>Cholangitis; Choledocholithiasis</condition>
  <arm_group>
    <arm_group_label>One stage stone removal in mild cholangitis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>one-stage stone removal at the first session of ERCP in mild cholangitis patients. The indomethacin 100mg anal route will be administered for all patients without allergy history</description>
  </arm_group>
  <arm_group>
    <arm_group_label>One stage stone removal in moderate cholangitis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>one-stage stone removal at the first session of ERCP in moderate cholangitis patients. The indomethacin 100mg anal route will be administered for all patients without allergy history</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>One stage treatment for mild and moderate cholangitis with choledocholithiasis</intervention_name>
    <description>one stage of stone removal in mild or moderate cholangitis.</description>
    <arm_group_label>One stage stone removal in mild cholangitis</arm_group_label>
    <arm_group_label>One stage stone removal in moderate cholangitis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  naïve papilla with a body temperature ≥37 °C who was diagnosed with mild to moderate&#xD;
             cholangitis associated with choledocholithiasis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  procedural failure requiring an anatomy-modifying procedure, such as a Billroth II&#xD;
             subtotal gastrectomy or R-en-Y gastrojejunostomy ;&#xD;
&#xD;
          -  stenosis of the pyloric ring ;&#xD;
&#xD;
          -  tumor-related obstruction;&#xD;
&#xD;
          -  failure to locate the papilla ;&#xD;
&#xD;
          -  active peptic ulcer bleeding ;&#xD;
&#xD;
          -  intolerance due to inadequate sedation&#xD;
&#xD;
          -  CBD sludge;&#xD;
&#xD;
          -  non-naïve papilla in ERCP&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>CHIH-MING LIANG, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaohsiung Chang Gung Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>813</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <results_reference>
    <citation>Miura F, Takada T, Strasberg SM, Solomkin JS, Pitt HA, Gouma DJ, Garden OJ, Buchler MW, Yoshida M, Mayumi T, Okamoto K, Gomi H, Kusachi S, Kiriyama S, Yokoe M, Kimura Y, Higuchi R, Yamashita Y, Windsor JA, Tsuyuguchi T, Gabata T, Itoi T, Hata J, Liau KH; Tokyo Guidelines Revision Comittee. TG13 flowchart for the management of acute cholangitis and cholecystitis. J Hepatobiliary Pancreat Sci. 2013 Jan;20(1):47-54. doi: 10.1007/s00534-012-0563-1.</citation>
    <PMID>23307003</PMID>
  </results_reference>
  <results_reference>
    <citation>Eto K, Kawakami H, Haba S, Yamato H, Okuda T, Yane K, Hayashi T, Ehira N, Onodera M, Matsumoto R, Matsubara Y, Takagi T, Sakamoto N; Hokkaido Interventional EUS/ERCP study (HONEST) group. Single-stage endoscopic treatment for mild to moderate acute cholangitis associated with choledocholithiasis: a multicenter, non-randomized, open-label and exploratory clinical trial. J Hepatobiliary Pancreat Sci. 2015 Dec;22(12):825-30. doi: 10.1002/jhbp.296. Epub 2015 Nov 25.</citation>
    <PMID>26510180</PMID>
  </results_reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>October 15, 2018</study_first_submitted>
  <study_first_submitted_qc>November 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>April 6, 2021</last_update_submitted>
  <last_update_submitted_qc>April 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute cholangitis</keyword>
  <keyword>choledocholithiasis</keyword>
  <keyword>ERCP</keyword>
  <keyword>One-stage treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholangitis</mesh_term>
    <mesh_term>Choledocholithiasis</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/NCT03754491
org study id: gimy54861439
nct id: NCT03754491
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In expert comment, performing the sphincterotomy for choledocholithiasis with acute
      cholangitis may increase bleeding and pancreatitis risks (from 2% to 10%). Therefore,
      investigators often perform biliary drainage in acute stage, and arrange 2nd session ERCP for
      stone removal later. However, in the recent study, single-stage endoscopic treatment may be
      still effective (stone removal rate 90%) and safe for mild to moderate acute cholangitis
      associated with choledocholithiasis. Investigators will carry out a prospective trial to
      analyze one-stage retrograde endoscopic common bile duct stone removal in mild and moderate
      cholangitis with choledocholithiasis to determine the safety, successful rate, and
      complications in these two groups.
Investigators will enroll 204 naïve papilla with a body temperature ≥37 °C who was diagnosed
      with mild to moderate cholangitis associated with choledocholithiasis. The method of
      one-stage: performing the stone removal at the first session of ERCP. The pancreas duct stent
      will be placed for preventing post ERCP pancreatitis (PEP) if necessary. The indomethacin
      100mg anal route will be administered for all patients without allergy history. All
      participants will receive the empiric antibiotics treatment for cholangitis.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Investigators will enroll 204 naïve papilla with a body temperature ≥37 °C who was diagnosed with mild or moderate cholangitis associated with choledocholithiasis for one-stage procedure to remove CBD stone.
primary purpose: Treatment
masking: None (Open Label)
measure: Post ERCP pancreatitis
time frame: After ERCP, an average of 7 days
description: Serum amylase > 3 times of (115 IU/L) with clinical abdominal pain
measure: Bowel perforation
time frame: After ERCP, an average of 7 days
description: Participants with sign of bowel perforation after ERCP
measure: Papillary bleeding
time frame: After ERCP, an average of 7 days
description: Participants with papillary bleeding after ERCP
measure: Success rate of stone removal
time frame: an average of 14 days.
description: Complete bile duct stone clearance
measure: Cost of hospitalization
time frame: From emergent department to the timing of being discharged, and an average of 30 days
description: Total cost in two individual groups in hospitalization.
measure: Mortality
time frame: an average of 30 days
description: Mortality during and after discharged
arm group label: One stage stone removal in mild cholangitis
arm group type: Experimental
description: one-stage stone removal at the first session of ERCP in mild cholangitis patients. The indomethacin 100mg anal route will be administered for all patients without allergy history
arm group label: One stage stone removal in moderate cholangitis
arm group type: Experimental
description: one-stage stone removal at the first session of ERCP in moderate cholangitis patients. The indomethacin 100mg anal route will be administered for all patients without allergy history
intervention type: Behavioral
intervention name: One stage treatment for mild and moderate cholangitis with choledocholithiasis
description: one stage of stone removal in mild or moderate cholangitis.
arm group label: One stage stone removal in mild cholangitis
arm group label: One stage stone removal in moderate cholangitis
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: CHIH-MING LIANG, MD
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
facility: 
country: Taiwan
citation: Miura F, Takada T, Strasberg SM, Solomkin JS, Pitt HA, Gouma DJ, Garden OJ, Buchler MW, Yoshida M, Mayumi T, Okamoto K, Gomi H, Kusachi S, Kiriyama S, Yokoe M, Kimura Y, Higuchi R, Yamashita Y, Windsor JA, Tsuyuguchi T, Gabata T, Itoi T, Hata J, Liau KH; Tokyo Guidelines Revision Comittee. TG13 flowchart for the management of acute cholangitis and cholecystitis. J Hepatobiliary Pancreat Sci. 2013 Jan;20(1):47-54. doi: 10.1007/s00534-012-0563-1.
PMID: 23307003
citation: Eto K, Kawakami H, Haba S, Yamato H, Okuda T, Yane K, Hayashi T, Ehira N, Onodera M, Matsumoto R, Matsubara Y, Takagi T, Sakamoto N; Hokkaido Interventional EUS/ERCP study (HONEST) group. Single-stage endoscopic treatment for mild to moderate acute cholangitis associated with choledocholithiasis: a multicenter, non-randomized, open-label and exploratory clinical trial. J Hepatobiliary Pancreat Sci. 2015 Dec;22(12):825-30. doi: 10.1002/jhbp.296. Epub 2015 Nov 25.
PMID: 26510180
responsible party type: Sponsor
mesh term: Cholangitis
mesh term: Choledocholithiasis
sharing ipd: No