<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/NCT03012243</url>
  </required_header>
  <id_info>
    <org_study_id>Bile aspiration vs drain trial</org_study_id>
    <nct_id>NCT03012243</nct_id>
  </id_info>
  <brief_title>Bile Aspiration vs Drain in Acute Cholecystitis</brief_title>
  <official_title>Randomized Controlled Trial of Bile Aspiration vs Drain in Acute Cholecystitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska Institutet</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>
      In order to compare percutaneous cholecystostomy and leaving a drain in situ with&#xD;
      percutaneous gallbladder aspiration we plan to undertake a double-blind randomized controlled&#xD;
      trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Percutaneous cholecystostomy is a minimally invasive technique for treatment of&#xD;
      cholecystitis. The cholecystostomy can be inserted transhepatically or transabdominally. The&#xD;
      transhepatic route is preferred due to lower risk for bile leakage. The drainage decompresses&#xD;
      the gallbladder and drains the bile. This decompression reduces the inflammatory process in&#xD;
      the gallbladder. Percutaneous cholecystostomy is often applied in patients not fit for&#xD;
      emergency surgery who are in need of intervention due to deterioration of their clinical&#xD;
      status. However, even though cholecystostomy is widely practised, it is not fully evaluated.&#xD;
&#xD;
      Percutaneous cholecystostomy has a high success rate, a low procedure-related mortality but a&#xD;
      30 day mortality of 15%. Furthermore, recurrence rates within one year after a&#xD;
      cholecystostomy are reported to range between 4 to 22%.&#xD;
&#xD;
      The time duration of the drainage differ between different studies and range from three to&#xD;
      six weeks. Optimal timing for drainage has not been studied. Two weeks seem to be sufficient&#xD;
      for a maturation of the tract for the transhepatic route and 3 weeks for the transabdominal&#xD;
      route. It has been suggested that a prolonged drainage duration is associated with increased&#xD;
      risk for recurrence of inflammation due to local irritation of the gallbladder mucosa by the&#xD;
      drain.&#xD;
&#xD;
      Percutaneous cholecystostomy is often considered as a bridge to surgery. However, less than&#xD;
      half of patients treated with PC are treated with cholecystectomy. This suggests that this&#xD;
      treatment is often chosen in a group not fit for surgery and often turns out to be a&#xD;
      definitive treatment.&#xD;
&#xD;
      Percutaneous gallbladder aspiration is a technique used for purposes similar to percutaneous&#xD;
      cholecystostomy. This technique is an alternative that may be more convenient than&#xD;
      percutaneous cholecystostomy. The aspiration is performed with a small gauge needle under&#xD;
      ultrasound guidance without leaving a drain. The aspiration leads to a decompression of the&#xD;
      gallbladder, which facilitates recovery. However, it has only been described in a few studies&#xD;
      and need more evaluation.&#xD;
&#xD;
      One single aspiration may be sufficient to relief symptoms for the majority of patients, but&#xD;
      if two aspirations are performed the success rate increases substantially. One randomized&#xD;
      controlled trial has been presented where PC is compared to gallbladder aspiration. In this&#xD;
      trial PC was superior to gallbladder aspiration in terms of effectiveness. In this trail,&#xD;
      however, only one aspiration was performed. No major complications occurred in either group&#xD;
      and minor complications were equal between the groups. In a retrospective study comparing&#xD;
      aspiration with PC it was found that gallbladder aspiration is safer than PC and has a&#xD;
      comparable clinical outcome.&#xD;
&#xD;
      It is believed that single decompressions are sufficient for reduction of the intraluminal&#xD;
      pressure. Only a minority of patients have positive bile cultures which, indicates that&#xD;
      infection is not a key mechanism in development of cholecystitis, which indicates that a&#xD;
      continuous drainage may not be necessary. As lower rates of complications are reported for&#xD;
      aspiration due to usage of smaller needle and no drain left that can dislocate and cause bile&#xD;
      leakage which is feared complication of PC. It is suggested that PC can have a role as a&#xD;
      salvage method when aspiration is not successful.&#xD;
&#xD;
      In order to compare percutaneous cholecystostomy and leaving a drain in situ with&#xD;
      percutaneous gallbladder aspiration we plan to undertake a double-blind randomized controlled&#xD;
      trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">August 1, 2023</start_date>
  <completion_date type="Anticipated">August 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amount of morphine administrated</measure>
    <time_frame>24 hours</time_frame>
    <description>The total amount of morphine required to relieve the pain the first 24 hours</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>5 days</time_frame>
    <description>Pain intensity rated on a Visual Analogue Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nausea</measure>
    <time_frame>5 days</time_frame>
    <description>Nausea estimated with a Likert scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-intervention</measure>
    <time_frame>5 days</time_frame>
    <description>Repeated percutaneous aspiration of adjustment of drain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body temperature</measure>
    <time_frame>5 days</time_frame>
    <description>Temperature measured daily</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CRP</measure>
    <time_frame>5 days</time_frame>
    <description>Daily measures of C-reactive protein</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LPK</measure>
    <time_frame>5 days</time_frame>
    <description>Daily measures of Leukocyte particle Concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to discharge</measure>
    <time_frame>30 days</time_frame>
    <description>Time from intervention to discharge from the hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>30 days</time_frame>
    <description>Procedure-related complications</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Cholecystitis, Acute</condition>
  <arm_group>
    <arm_group_label>Cholecystostomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Percutaneous cholecystostomy, leaving drain in situ</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gallbladder aspiration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gallblader aspiration without drain</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Gallbladder aspiration</intervention_name>
    <description>Percutaneous ultrasound-guided aspiration of bile from the gallbladder. This is performed without leaving a drain in the gallbladder. The aspiration is performed with the intention to relief the pressure in the gallbladder, without drain.</description>
    <arm_group_label>Gallbladder aspiration</arm_group_label>
    <other_name>Percutaneous intervention</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cholecystostomy</intervention_name>
    <description>Ultrasound-guided insertion of drain in the gallbladder. The drain is left in the gallbladder until clinical assessment and laboratory analyses show that the acute cholecystitis has been successfully treated.</description>
    <arm_group_label>Cholecystostomy</arm_group_label>
    <other_name>Percutaneous intervention</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute cholecystitis, not warranting acute cholecystectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Indication for acute cholecystectomy, i.e. history &lt; 5 days and no contraindication to&#xD;
             surgery&#xD;
&#xD;
          -  Liver cirrhosis&#xD;
&#xD;
          -  Ascites&#xD;
&#xD;
          -  Emphysematous cholecystitis&#xD;
&#xD;
          -  Gallbladder perforation&#xD;
&#xD;
          -  Suspected malignant condition&#xD;
&#xD;
          -  Portal Hypertension&#xD;
&#xD;
          -  Biliary pancreatitis&#xD;
&#xD;
          -  Common bile duct stones&#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_official>
    <last_name>Gabriel Sandblom, Assoc Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Agnieszka Popowicz, MD</last_name>
    <phone>+46 73 582 62 13</phone>
    <email>a.e.popowicz@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gabriel Sandblom, Assoc Prof</last_name>
    <phone>+46 70 415 82 18</phone>
    <email>gabriel.sandblom@ki.se</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Karolinska University Hospital, Center for Digestive Diseases</name>
      <address>
        <city>Stockholm</city>
        <zip>14186</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>March 1, 2023</last_update_submitted>
  <last_update_submitted_qc>March 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Gabriel Sandblom</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholecystitis</mesh_term>
    <mesh_term>Acalculous Cholecystitis</mesh_term>
    <mesh_term>Cholecystitis, Acute</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/NCT03012243
org study id: Bile aspiration vs drain trial
nct id: NCT03012243
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In order to compare percutaneous cholecystostomy and leaving a drain in situ with
      percutaneous gallbladder aspiration we plan to undertake a double-blind randomized controlled
      trial.
Percutaneous cholecystostomy is a minimally invasive technique for treatment of
      cholecystitis. The cholecystostomy can be inserted transhepatically or transabdominally. The
      transhepatic route is preferred due to lower risk for bile leakage. The drainage decompresses
      the gallbladder and drains the bile. This decompression reduces the inflammatory process in
      the gallbladder. Percutaneous cholecystostomy is often applied in patients not fit for
      emergency surgery who are in need of intervention due to deterioration of their clinical
      status. However, even though cholecystostomy is widely practised, it is not fully evaluated.

      Percutaneous cholecystostomy has a high success rate, a low procedure-related mortality but a
      30 day mortality of 15%. Furthermore, recurrence rates within one year after a
      cholecystostomy are reported to range between 4 to 22%.

      The time duration of the drainage differ between different studies and range from three to
      six weeks. Optimal timing for drainage has not been studied. Two weeks seem to be sufficient
      for a maturation of the tract for the transhepatic route and 3 weeks for the transabdominal
      route. It has been suggested that a prolonged drainage duration is associated with increased
      risk for recurrence of inflammation due to local irritation of the gallbladder mucosa by the
      drain.

      Percutaneous cholecystostomy is often considered as a bridge to surgery. However, less than
      half of patients treated with PC are treated with cholecystectomy. This suggests that this
      treatment is often chosen in a group not fit for surgery and often turns out to be a
      definitive treatment.

      Percutaneous gallbladder aspiration is a technique used for purposes similar to percutaneous
      cholecystostomy. This technique is an alternative that may be more convenient than
      percutaneous cholecystostomy. The aspiration is performed with a small gauge needle under
      ultrasound guidance without leaving a drain. The aspiration leads to a decompression of the
      gallbladder, which facilitates recovery. However, it has only been described in a few studies
      and need more evaluation.

      One single aspiration may be sufficient to relief symptoms for the majority of patients, but
      if two aspirations are performed the success rate increases substantially. One randomized
      controlled trial has been presented where PC is compared to gallbladder aspiration. In this
      trial PC was superior to gallbladder aspiration in terms of effectiveness. In this trail,
      however, only one aspiration was performed. No major complications occurred in either group
      and minor complications were equal between the groups. In a retrospective study comparing
      aspiration with PC it was found that gallbladder aspiration is safer than PC and has a
      comparable clinical outcome.

      It is believed that single decompressions are sufficient for reduction of the intraluminal
      pressure. Only a minority of patients have positive bile cultures which, indicates that
      infection is not a key mechanism in development of cholecystitis, which indicates that a
      continuous drainage may not be necessary. As lower rates of complications are reported for
      aspiration due to usage of smaller needle and no drain left that can dislocate and cause bile
      leakage which is feared complication of PC. It is suggested that PC can have a role as a
      salvage method when aspiration is not successful.

      In order to compare percutaneous cholecystostomy and leaving a drain in situ with
      percutaneous gallbladder aspiration we plan to undertake a double-blind randomized controlled
      trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Amount of morphine administrated
time frame: 24 hours
description: The total amount of morphine required to relieve the pain the first 24 hours
measure: Pain
time frame: 5 days
description: Pain intensity rated on a Visual Analogue Scale
measure: Nausea
time frame: 5 days
description: Nausea estimated with a Likert scale
measure: Re-intervention
time frame: 5 days
description: Repeated percutaneous aspiration of adjustment of drain
measure: Body temperature
time frame: 5 days
description: Temperature measured daily
measure: CRP
time frame: 5 days
description: Daily measures of C-reactive protein
measure: LPK
time frame: 5 days
description: Daily measures of Leukocyte particle Concentration
measure: Time to discharge
time frame: 30 days
description: Time from intervention to discharge from the hospital
measure: Complications
time frame: 30 days
description: Procedure-related complications
arm group label: Cholecystostomy
arm group type: Active Comparator
description: Percutaneous cholecystostomy, leaving drain in situ
arm group label: Gallbladder aspiration
arm group type: Experimental
description: Gallblader aspiration without drain
intervention type: Procedure
intervention name: Gallbladder aspiration
description: Percutaneous ultrasound-guided aspiration of bile from the gallbladder. This is performed without leaving a drain in the gallbladder. The aspiration is performed with the intention to relief the pressure in the gallbladder, without drain.
arm group label: Gallbladder aspiration
other name: Percutaneous intervention
intervention type: Procedure
intervention name: Cholecystostomy
description: Ultrasound-guided insertion of drain in the gallbladder. The drain is left in the gallbladder until clinical assessment and laboratory analyses show that the acute cholecystitis has been successfully treated.
arm group label: Cholecystostomy
other name: Percutaneous intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gabriel Sandblom, Assoc Prof
role: Principal Investigator
affiliation: Karolinska Institutet
last name: Agnieszka Popowicz, MD
phone: +46 73 582 62 13
email: a.e.popowicz@gmail.com
last name: Gabriel Sandblom, Assoc Prof
phone: +46 70 415 82 18
email: gabriel.sandblom@ki.se
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Gabriel Sandblom
investigator title: Associate Professor
mesh term: Cholecystitis
mesh term: Acalculous Cholecystitis
mesh term: Cholecystitis, Acute
sharing ipd: No