<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/NCT04463381</url>
  </required_header>
  <id_info>
    <org_study_id>22/05/2020</org_study_id>
    <nct_id>NCT04463381</nct_id>
  </id_info>
  <brief_title>Choledochotomy Techniques During LCBDE</brief_title>
  <official_title>Impact of Choledochotomy Techniques During Laparoscopic CBD Exploration on Short- and Long-term Clinical Outcomes: Time to Change Concepts</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sohag University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sohag University</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      complications after laparoscopic common bile duct exploration (LCBDE) regarding the&#xD;
      choledochotomy technique have not been adequately studied in the literature. Therefore, this&#xD;
      study aimed to retrospectively analyze and compare the impact of choledochotomy techniques&#xD;
      during LCBDE among patients with choledocholithiasis during the early and late postoperative&#xD;
      periods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: complications after laparoscopic common bile duct exploration (LCBDE) regarding&#xD;
      the choledochotomy technique have not been adequately studied in the literature. Therefore,&#xD;
      this study aimed to retrospectively analyze and compare the impact of choledochotomy&#xD;
      techniques during LCBDE among patients with choledocholithiasis during the early and late&#xD;
      postoperative periods.&#xD;
&#xD;
      Methods: from March 2014 to February 2018, 85 patients with choledocholithiasis (52 females&#xD;
      and 33 males) were enrolled in this study. These patients were treated by LCBDE using various&#xD;
      choledochotomy techniques, including scalpel or scissor (28 patients, 33%) in group I, using&#xD;
      diathermy hook (35 patients, 41%) in group II, or using an ultrasonic device (22 patients, 26&#xD;
      %) in group III. Postoperative follow-up was done for assessment of all possible&#xD;
      complications either early (within 3-6 months postoperatively), or late (2-6 years&#xD;
      postoperatively) with meticulous observation and study of any relevant postoperative event.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2014</start_date>
  <completion_date type="Actual">March 1, 2020</completion_date>
  <primary_completion_date type="Actual">February 28, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>biliary leakage/fistula</measure>
    <time_frame>first postoperative 6 months up to 6 years postoperatively</time_frame>
    <description>According to the international study group of liver surgery, bile leakage is defined as fluid with an elevated bilirubin level (3 times higher than the serum bilirubin measured at the same time) in the abdominal drain or the intra-abdominal fluid on or after POD 3, or as the need for radiologic intervention because of biliary collections or re-laparotomy resulting from biliary peritonitis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>biliary stricture</measure>
    <time_frame>2-6 years</time_frame>
    <description>The biliary stricture is known as abnormal narrowing of the bile duct associated with the rising of cholestasis indexes. Additionally, it has required an invasive treatment such as ERCP, percutaneous transhepatic drainage, or re-surgery [16]. Biliary complications were diagnosed by trans-tubal cholangiography or through MRCP and could be managed conservatively, ERCP, if there is an accessible route, PTD or surgical intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>operative time</measure>
    <time_frame>from incision to closure</time_frame>
    <description>from incision to closure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intraoperative bleeding</measure>
    <time_frame>during surgery</time_frame>
    <description>in mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>conversion rate</measure>
    <time_frame>during surgery</time_frame>
    <description>from laparoscopy to open</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>jaundice</measure>
    <time_frame>2-6 years</time_frame>
    <description>missed stone</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>wound sepsis</measure>
    <time_frame>2-6 years</time_frame>
    <description>infection of the wound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cholangitis</measure>
    <time_frame>2-6 years</time_frame>
    <description>inflammation of the biliary system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>wound dehiscence</measure>
    <time_frame>2-6 years</time_frame>
    <description>Gapped wound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peritoneal sepsis and abscess</measure>
    <time_frame>first postoperative 6 months</time_frame>
    <description>peritonitis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrent stones</measure>
    <time_frame>2-6 years</time_frame>
    <description>recurrence</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">85</enrollment>
  <condition>Choledocholithiasis</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>sharp choledochotomy by a scalpel or scissor</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>choledochotomy by a diathermy hook</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <description>choledochotomy by an ultrasonic device</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>choledochotomy techniques during LCBDE</intervention_name>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        During the study period, 85 patients (52 females and 33 males) were enrolled in this study&#xD;
        which they were complaining of manifestations of CBD stones and treated using laparoscopic&#xD;
        approaches, using various choledochotomy techniques.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult patients with choledocholithiasis who underwent LCBDE combined with LC were&#xD;
             enrolled in this study. No limitations as regards the stone sizes or numbers were&#xD;
             considered. The CBD diameter should be at least ± 1 cm.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria were normal caliber or stenosed CBD, or the presence of overt&#xD;
             cholangitis. Additionally, treated patients with the trans-cystic approach for stone&#xD;
             extraction were excluded from this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emad Ali Ahmed, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sohag University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sohag University</name>
      <address>
        <city>Sohag</city>
        <zip>82524</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 3, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sohag University</investigator_affiliation>
    <investigator_full_name>Emad Ali Ahmed Ali</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>choledochotomy technique</keyword>
  <keyword>CBD stones</keyword>
  <keyword>choledocholithiasis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Choledocholithiasis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04463381
org study id: 22/05/2020
nct id: NCT04463381
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
complications after laparoscopic common bile duct exploration (LCBDE) regarding the
      choledochotomy technique have not been adequately studied in the literature. Therefore, this
      study aimed to retrospectively analyze and compare the impact of choledochotomy techniques
      during LCBDE among patients with choledocholithiasis during the early and late postoperative
      periods.
Background: complications after laparoscopic common bile duct exploration (LCBDE) regarding
      the choledochotomy technique have not been adequately studied in the literature. Therefore,
      this study aimed to retrospectively analyze and compare the impact of choledochotomy
      techniques during LCBDE among patients with choledocholithiasis during the early and late
      postoperative periods.

      Methods: from March 2014 to February 2018, 85 patients with choledocholithiasis (52 females
      and 33 males) were enrolled in this study. These patients were treated by LCBDE using various
      choledochotomy techniques, including scalpel or scissor (28 patients, 33%) in group I, using
      diathermy hook (35 patients, 41%) in group II, or using an ultrasonic device (22 patients, 26
      %) in group III. Postoperative follow-up was done for assessment of all possible
      complications either early (within 3-6 months postoperatively), or late (2-6 years
      postoperatively) with meticulous observation and study of any relevant postoperative event.
observational model: Cohort
time perspective: Retrospective
measure: biliary leakage/fistula
time frame: first postoperative 6 months up to 6 years postoperatively
description: According to the international study group of liver surgery, bile leakage is defined as fluid with an elevated bilirubin level (3 times higher than the serum bilirubin measured at the same time) in the abdominal drain or the intra-abdominal fluid on or after POD 3, or as the need for radiologic intervention because of biliary collections or re-laparotomy resulting from biliary peritonitis
measure: biliary stricture
time frame: 2-6 years
description: The biliary stricture is known as abnormal narrowing of the bile duct associated with the rising of cholestasis indexes. Additionally, it has required an invasive treatment such as ERCP, percutaneous transhepatic drainage, or re-surgery [16]. Biliary complications were diagnosed by trans-tubal cholangiography or through MRCP and could be managed conservatively, ERCP, if there is an accessible route, PTD or surgical intervention.
measure: operative time
time frame: from incision to closure
description: from incision to closure
measure: intraoperative bleeding
time frame: during surgery
description: in mm
measure: conversion rate
time frame: during surgery
description: from laparoscopy to open
measure: jaundice
time frame: 2-6 years
description: missed stone
measure: wound sepsis
time frame: 2-6 years
description: infection of the wound
measure: cholangitis
time frame: 2-6 years
description: inflammation of the biliary system
measure: wound dehiscence
time frame: 2-6 years
description: Gapped wound
measure: Peritoneal sepsis and abscess
time frame: first postoperative 6 months
description: peritonitis
measure: Recurrent stones
time frame: 2-6 years
description: recurrence
arm group label: Group 1
description: sharp choledochotomy by a scalpel or scissor
arm group label: Group 2
description: choledochotomy by a diathermy hook
arm group label: Group 3
description: choledochotomy by an ultrasonic device
intervention type: Procedure
intervention name: choledochotomy techniques during LCBDE
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 17 Years
maximum age: N/A
healthy volunteers: No
last name: Emad Ali Ahmed, MD, PhD
role: Principal Investigator
affiliation: Sohag University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Sohag University
investigator full name: Emad Ali Ahmed Ali
investigator title: Principal investigator
mesh term: Choledocholithiasis
sharing ipd: Undecided