<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/NCT04475796</url>
  </required_header>
  <id_info>
    <org_study_id>124569124569</org_study_id>
    <nct_id>NCT04475796</nct_id>
  </id_info>
  <brief_title>Early Versus Delayed Laparoscopic Cholecystectomy Following ERCP in Concomitant Gallstones and Common Bile Duct Stones</brief_title>
  <official_title>Early Versus Delayed Laparoscopic Cholecystectomy Following ERCP in Concomitant Gallstones and Common Bile Duct Stones</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kafrelsheikh University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kafrelsheikh 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>
      The present study aimed to compare early and delayed laparoscopic cholecystectomy after ERCP&#xD;
      for CBDs and gallstones.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endoscopic retrograde cholangiopancreatography (ERCP) followed by laparoscopic&#xD;
      cholecystectomy (LC) is a commonly performed treatment modality for concomitant common bile&#xD;
      duct stones (CBDs) and gallbladder stones. There has been a debate about the appropriate&#xD;
      timing of laparoscopic cholecystectomy after ERCP. The present study aimed to compare early&#xD;
      and delayed laparoscopic cholecystectomy after ERCP for CBDs and gallstones adding new&#xD;
      parameters like Nassar scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">May 1, 2020</completion_date>
  <primary_completion_date type="Actual">February 1, 2020</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>operative time</measure>
    <time_frame>one day</time_frame>
    <description>the time to perform laparoscopic cholecystectomy from the time of incision to the last suture</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>intraoperative difficulty and complications</measure>
    <time_frame>one day</time_frame>
    <description>the difficulties that face the surgeon during the surgery and the early complications that result</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Choledocholithiasis With Cholecystitis</condition>
  <arm_group>
    <arm_group_label>Early group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic cholecystectomy</intervention_name>
    <description>Laparoscopic cholecystectomy performed after ERCP</description>
    <arm_group_label>Delayed group</arm_group_label>
    <arm_group_label>Early group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who underwent laparoscopic cholecystectomy after clearance of CBDs by ERCP&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  advanced liver cirrhosis, pancreatitis, acute cholangitis, suspected malignancy,&#xD;
             severe malnutrition, and pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>adult</gender_description>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Aouf, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kafrelsheikh University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kafrelsheikh University</name>
      <address>
        <city>Kafr Ash Shaykh</city>
        <state>Kafr Al Sheikh</state>
        <zip>33516</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kafrelsheikh University</investigator_affiliation>
    <investigator_full_name>Ahmed Aouf</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>Choledocholithiasis</keyword>
  <keyword>Early</keyword>
  <keyword>Delayed</keyword>
  <keyword>Laparoscopic cholecystectomy</keyword>
  <keyword>ERCP</keyword>
  <keyword>Nassar scale</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholecystitis</mesh_term>
    <mesh_term>Gallstones</mesh_term>
    <mesh_term>Choledocholithiasis</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/NCT04475796
org study id: 124569124569
nct id: NCT04475796
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The present study aimed to compare early and delayed laparoscopic cholecystectomy after ERCP
      for CBDs and gallstones.
Endoscopic retrograde cholangiopancreatography (ERCP) followed by laparoscopic
      cholecystectomy (LC) is a commonly performed treatment modality for concomitant common bile
      duct stones (CBDs) and gallbladder stones. There has been a debate about the appropriate
      timing of laparoscopic cholecystectomy after ERCP. The present study aimed to compare early
      and delayed laparoscopic cholecystectomy after ERCP for CBDs and gallstones adding new
      parameters like Nassar scale.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: operative time
time frame: one day
description: the time to perform laparoscopic cholecystectomy from the time of incision to the last suture
measure: intraoperative difficulty and complications
time frame: one day
description: the difficulties that face the surgeon during the surgery and the early complications that result
arm group label: Early group
arm group type: Active Comparator
arm group label: Delayed group
arm group type: Active Comparator
intervention type: Procedure
intervention name: Laparoscopic cholecystectomy
description: Laparoscopic cholecystectomy performed after ERCP
arm group label: Delayed group
arm group label: Early group
criteria: 
gender: All
gender based: Yes
gender description: adult
minimum age: 16 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ahmed Aouf, Dr.
role: Principal Investigator
affiliation: Kafrelsheikh University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Kafrelsheikh University
investigator full name: Ahmed Aouf
investigator title: Dr
mesh term: Cholecystitis
mesh term: Gallstones
mesh term: Choledocholithiasis