<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/NCT01687959</url>
  </required_header>
  <id_info>
    <org_study_id>BEZM-LC-postERCP</org_study_id>
    <nct_id>NCT01687959</nct_id>
  </id_info>
  <brief_title>Timing of Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiography for Acute Biliary Pancreatitis</brief_title>
  <official_title>Prospective Randomized Clinical Study for Timing of Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiography for Acute Biliary Pancreatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bezmialem Vakif University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bezmialem Vakif University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Timing of laparoscopic cholecystectomy following after endoscopic retrograde cholangiography&#xD;
      for acute biliary pancreatitis is a controversial issue. There are still many confounding&#xD;
      findings offering either early laparoscopic cholecystectomy within 72 hours following&#xD;
      endoscopic sphincterotomy or delayed surgery after 6 weeks. Peritoneal plasmin system is&#xD;
      known to be an important factor in peritoneal healing and adhesion formation. Measurement of&#xD;
      tissue concentrations of tissue-type plasminogen activator and its specific activity,&#xD;
      urokinase-type plasminogen activator, and plasminogen activator inhibitor type 1 are thought&#xD;
      to be helpful to show peritoneal adhesions after endoscopic sphincterotomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Peritoneal fibrinolysis is crucial in peritoneal healing processes and subsequent adhesion&#xD;
      formation. It is expected that endoscopic retrograde cholangiography is a trauma causing&#xD;
      adhesions around the hepatobiliary area. Such adhesions may cause some difficulty for&#xD;
      consequent gallbladder surgery. For that reason, tissue measurements of factors indicating&#xD;
      degree of peritoneal healing and adhesion is helpful for timing of such surgical&#xD;
      interventions.&#xD;
&#xD;
      Patients are going to be randomized to early and delayed surgery groups. Sampling of&#xD;
      peritoneum around the gallbladder during laparoscopic cholecystectomy in patients after&#xD;
      endoscopic retrograde cholangiography is performed. Tissue concentrations of tissue-type&#xD;
      plasminogen activator and its specific activity, urokinase-type plasminogen activator, and&#xD;
      plasminogen activator inhibitor type 1 are going to be studied by using commercial assays.&#xD;
&#xD;
      Peritoneal fibrinolytic activity and surgical outcomes are going to be compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">August 2015</completion_date>
  <primary_completion_date type="Anticipated">June 2015</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>measurement of peritoneal fibrinolytic response following endoscopic retrograde cholangiography</measure>
    <time_frame>six months</time_frame>
    <description>measurement of tissue concentrations of tissue-type plasminogen activator and its specific activity, urokinase-type plasminogen activator , and plasminogen activator inhibitor type 1</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>surgical outcomes of laparoscopic cholecystectomy following endoscopic retrograde cholangiography</measure>
    <time_frame>six months</time_frame>
    <description>evaluation of surgical outcomes including operating time, morbidity and mortality of laparoscopic cholecystectomy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Cholelithiasis Associated With Common Bile Duct Stones</condition>
  <arm_group>
    <arm_group_label>activity of peritoneal fibrinolysis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>measurements of peritoneal fibrinolysis using tissue-type plasminogen activator and its specific activity, urokinase-type plasminogen activator, and plasminogen activator inhibitor type 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>surgical outcomes</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>surgical outcomes of laparoscopic cholecystectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>tissue sampling from peritoneum of the gallbladder</intervention_name>
    <description>tissue sampling from peritoneum of the gallbladder during laparoscopic cholecystectomy after an acute attack of acute biliary pancreatitis</description>
    <arm_group_label>activity of peritoneal fibrinolysis</arm_group_label>
    <arm_group_label>surgical outcomes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  cholelithiasis following endoscopic retrograde cholangiography for acute biliary&#xD;
             pancreatitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contraindication to laparoscopy&#xD;
&#xD;
          -  unsuccessful endoscopic retrograde cholangiography&#xD;
&#xD;
          -  complicated acute biliary pancreatitis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>department of general surgery; Bezmialem vakif university</name>
      <address>
        <city>Istanbul</city>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>January 27, 2015</last_update_submitted>
  <last_update_submitted_qc>January 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bezmialem Vakif University</investigator_affiliation>
    <investigator_full_name>Mustafa Hasbahceci</investigator_full_name>
    <investigator_title>MD, general surgeon</investigator_title>
  </responsible_party>
  <keyword>cholelithiasis</keyword>
  <keyword>laparoscopic cholecystectomy</keyword>
  <keyword>endoscopic sphincterotomy</keyword>
  <keyword>choledocholithiasis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</mesh_term>
    <mesh_term>Cholelithiasis</mesh_term>
    <mesh_term>Cholecystolithiasis</mesh_term>
    <mesh_term>Gallstones</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/NCT01687959
org study id: BEZM-LC-postERCP
nct id: NCT01687959
lead sponsor: 
has dmc: No
Timing of laparoscopic cholecystectomy following after endoscopic retrograde cholangiography
      for acute biliary pancreatitis is a controversial issue. There are still many confounding
      findings offering either early laparoscopic cholecystectomy within 72 hours following
      endoscopic sphincterotomy or delayed surgery after 6 weeks. Peritoneal plasmin system is
      known to be an important factor in peritoneal healing and adhesion formation. Measurement of
      tissue concentrations of tissue-type plasminogen activator and its specific activity,
      urokinase-type plasminogen activator, and plasminogen activator inhibitor type 1 are thought
      to be helpful to show peritoneal adhesions after endoscopic sphincterotomy.
Peritoneal fibrinolysis is crucial in peritoneal healing processes and subsequent adhesion
      formation. It is expected that endoscopic retrograde cholangiography is a trauma causing
      adhesions around the hepatobiliary area. Such adhesions may cause some difficulty for
      consequent gallbladder surgery. For that reason, tissue measurements of factors indicating
      degree of peritoneal healing and adhesion is helpful for timing of such surgical
      interventions.

      Patients are going to be randomized to early and delayed surgery groups. Sampling of
      peritoneum around the gallbladder during laparoscopic cholecystectomy in patients after
      endoscopic retrograde cholangiography is performed. Tissue concentrations of tissue-type
      plasminogen activator and its specific activity, urokinase-type plasminogen activator, and
      plasminogen activator inhibitor type 1 are going to be studied by using commercial assays.

      Peritoneal fibrinolytic activity and surgical outcomes are going to be compared.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: measurement of peritoneal fibrinolytic response following endoscopic retrograde cholangiography
time frame: six months
description: measurement of tissue concentrations of tissue-type plasminogen activator and its specific activity, urokinase-type plasminogen activator , and plasminogen activator inhibitor type 1
measure: surgical outcomes of laparoscopic cholecystectomy following endoscopic retrograde cholangiography
time frame: six months
description: evaluation of surgical outcomes including operating time, morbidity and mortality of laparoscopic cholecystectomy
arm group label: activity of peritoneal fibrinolysis
arm group type: Active Comparator
description: measurements of peritoneal fibrinolysis using tissue-type plasminogen activator and its specific activity, urokinase-type plasminogen activator, and plasminogen activator inhibitor type 1
arm group label: surgical outcomes
arm group type: Active Comparator
description: surgical outcomes of laparoscopic cholecystectomy
intervention type: Other
intervention name: tissue sampling from peritoneum of the gallbladder
description: tissue sampling from peritoneum of the gallbladder during laparoscopic cholecystectomy after an acute attack of acute biliary pancreatitis
arm group label: activity of peritoneal fibrinolysis
arm group label: surgical outcomes
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Bezmialem Vakif University
investigator full name: Mustafa Hasbahceci
investigator title: MD, general surgeon
mesh term: Pancreatitis
mesh term: Cholelithiasis
mesh term: Cholecystolithiasis
mesh term: Gallstones