<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/NCT02212717</url>
  </required_header>
  <id_info>
    <org_study_id>CREC-2014.301-T</org_study_id>
    <nct_id>NCT02212717</nct_id>
  </id_info>
  <brief_title>A Randomized Controlled Trial on EGBD vs PC for Acute Cholecystitis.</brief_title>
  <acronym>DRAC</acronym>
  <official_title>Endosonography-guided Gallbladder Drainage (EGBD) Versus Percutaneous Cholecystostomy (PC) in Patients Suffering From Acute Cholecystitis That Are Unsuitable for Surgery. A Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Society for Gastrointestinal Endoscopy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tokyo Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kinki University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Barcelona</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute cholecystitis commonly occurs in elderly patients that are high-risk candidates for&#xD;
      surgery. Percutaneous cholecystostomy (PC) is frequently employed for gallbladder drainage in&#xD;
      these patients. Recently, the feasibility of EUS-guided gallbladder drainage (EGBD) in&#xD;
      treatment of this condition has been demonstrated but how the two procedures compare to one&#xD;
      another is uncertain.&#xD;
&#xD;
      The aim of this study is to compare EGBD versus PC as a definitive treatment, in high-risk&#xD;
      patients suffering from acute cholecystitis in a randomized controlled trial. We hypothesize&#xD;
      that EGBD can reduce the morbidity, re-intervention and mortality when compared to PC.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">March 2019</completion_date>
  <primary_completion_date type="Actual">February 2018</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Overall morbidities</measure>
    <time_frame>1 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Technical success</measure>
    <time_frame>30 days</time_frame>
    <description>Technical success is defined as the ability to access and drain the gallbladder by placement of a drainage tube or stent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain scores</measure>
    <time_frame>7 days</time_frame>
    <description>Pain assessment would be performed using the visual-analogue scale (1 to 100) on post-procedural days 1 to 7.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesic requirements</measure>
    <time_frame>7 days</time_frame>
    <description>The amount of analgesic consumed during admission will be recorded and compared between groups. Oral panadol and intravenous tramadol (or equivalent) would be provided as required to patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stone clearance rates</measure>
    <time_frame>1 years</time_frame>
    <description>The presence or absence of gallstones after 1 years would be assessed by abdominal ultrasonography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical success</measure>
    <time_frame>30 days</time_frame>
    <description>Clinical success is obtained when the patient is afebrile and had more than 20% decrease in white cell counts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reintervention rate</measure>
    <time_frame>1 year</time_frame>
    <description>The number of patients requiring biliary related re-interventions within 1 year</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-admission rate</measure>
    <time_frame>1 year</time_frame>
    <description>The number of patients requiring hospital re-admissions due to biliary related events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Acute Cholecystitis</condition>
  <arm_group>
    <arm_group_label>EUS-guided gallbladder drainage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Percutaneous cholecystomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>EUS-guided gallbladder drainage (EGBD)</intervention_name>
    <description>The gallbladder would be identified by a linear echoendoscope (EUS) and a suitable puncture site in the stomach or the duodenum without intervening blood vessels would be located. The gallbladder would be punctured with a 19-gauge needle and a guidewire would be passed through the needle and looped in the gallbladder. The Hot AXIOS stent would then be inserted. A naso-gallbladder drain or a 5-7Fr double pigtail stents can be inserted into gallbladder if the effluent failed to clear after irrigation. This would be performed to improve drainage and avoid obstruction of the stent.</description>
    <arm_group_label>EUS-guided gallbladder drainage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous cholecystostomy (PC)</intervention_name>
    <description>Trained interventional radiologists in the respective hospitals would perform the procedure under local anesthesia. A transhepatic route would be used in all patients to decrease bile leakage. An 8.5 Fr pigtail drainage catheter would be placed between the 8th or 9th intercostal space under sonographic and fluoroscopic guidance. The pigtail catheter would be drained to a bedside bag.</description>
    <arm_group_label>Percutaneous cholecystomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consecutive patients aged ≥ 18 years old admitted for acute cholecystitis but are&#xD;
             unsuitable for early laparoscopic cholecystectomy due to poor premorbid conditions&#xD;
             including: American society of anesthesiology grading ≥ 3, APACHE score ≥ 12, limited&#xD;
             life expectancy (less than 2 years) or deemed unsuitable for general anesthesia would&#xD;
             be included.&#xD;
&#xD;
          -  Written informed consent from patient or guardian who is able to understand the nature&#xD;
             and possible consequences of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Patients unwilling to undergo follow-up assessments&#xD;
&#xD;
          -  Patients with suspected gangrene or perforation of the gallbladder&#xD;
&#xD;
          -  Patients diagnosed with concomitant liver abscess or pancreatitis (defined as elevated&#xD;
             serum amylase more than three times the upper limit of normal)&#xD;
&#xD;
          -  Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus,&#xD;
             stomach and duodenum&#xD;
&#xD;
          -  Patients with liver cirrhosis, portal hypertension and/or gastric varices&#xD;
&#xD;
          -  Abnormal coagulation: INR &gt; 1.5 and/or platelets &lt; 50.000/mm3&#xD;
&#xD;
          -  Previous drainage of the gallbladder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chinese University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <state>Hong Kong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kinki University Hospital</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical University Hospital</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Rio Hortega</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>Japan</country>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>de la Serna-Higuera C, Perez-Miranda M, Gil-Simon P, Ruiz-Zorrilla R, Diez-Redondo P, Alcaide N, Sancho-del Val L, Nunez-Rodriguez H. EUS-guided transenteric gallbladder drainage with a new fistula-forming, lumen-apposing metal stent. Gastrointest Endosc. 2013 Feb;77(2):303-8. doi: 10.1016/j.gie.2012.09.021. Epub 2012 Dec 1. No abstract available.</citation>
    <PMID>23206813</PMID>
  </reference>
  <reference>
    <citation>Itoi T, Binmoeller KF, Shah J, Sofuni A, Itokawa F, Kurihara T, Tsuchiya T, Ishii K, Tsuji S, Ikeuchi N, Moriyasu F. Clinical evaluation of a novel lumen-apposing metal stent for endosonography-guided pancreatic pseudocyst and gallbladder drainage (with videos). Gastrointest Endosc. 2012 Apr;75(4):870-6. doi: 10.1016/j.gie.2011.10.020. Epub 2012 Jan 31.</citation>
    <PMID>22301347</PMID>
  </reference>
  <reference>
    <citation>Teoh AY, Binmoeller KF, Lau JY. Single-step EUS-guided puncture and delivery of a lumen-apposing stent for gallbladder drainage using a novel cautery-tipped stent delivery system. Gastrointest Endosc. 2014 Dec;80(6):1171. doi: 10.1016/j.gie.2014.03.038. Epub 2014 May 13. No abstract available.</citation>
    <PMID>24830582</PMID>
  </reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>July 29, 2019</last_update_submitted>
  <last_update_submitted_qc>July 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Anthony Teoh</investigator_full_name>
    <investigator_title>Honorary Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Acute cholecystitis</keyword>
  <keyword>EUS-guided gallbladder drainage</keyword>
  <keyword>Percutaneous cholecystostomy</keyword>
  <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>
  <!-- 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/NCT02212717
org study id: CREC-2014.301-T
nct id: NCT02212717
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Acute cholecystitis commonly occurs in elderly patients that are high-risk candidates for
      surgery. Percutaneous cholecystostomy (PC) is frequently employed for gallbladder drainage in
      these patients. Recently, the feasibility of EUS-guided gallbladder drainage (EGBD) in
      treatment of this condition has been demonstrated but how the two procedures compare to one
      another is uncertain.

      The aim of this study is to compare EGBD versus PC as a definitive treatment, in high-risk
      patients suffering from acute cholecystitis in a randomized controlled trial. We hypothesize
      that EGBD can reduce the morbidity, re-intervention and mortality when compared to PC.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall morbidities
time frame: 1 years
measure: Technical success
time frame: 30 days
description: Technical success is defined as the ability to access and drain the gallbladder by placement of a drainage tube or stent.
measure: Pain scores
time frame: 7 days
description: Pain assessment would be performed using the visual-analogue scale (1 to 100) on post-procedural days 1 to 7.
measure: Analgesic requirements
time frame: 7 days
description: The amount of analgesic consumed during admission will be recorded and compared between groups. Oral panadol and intravenous tramadol (or equivalent) would be provided as required to patients.
measure: Stone clearance rates
time frame: 1 years
description: The presence or absence of gallstones after 1 years would be assessed by abdominal ultrasonography
measure: Clinical success
time frame: 30 days
description: Clinical success is obtained when the patient is afebrile and had more than 20% decrease in white cell counts.
measure: Reintervention rate
time frame: 1 year
description: The number of patients requiring biliary related re-interventions within 1 year
measure: Re-admission rate
time frame: 1 year
description: The number of patients requiring hospital re-admissions due to biliary related events
arm group label: EUS-guided gallbladder drainage
arm group type: Active Comparator
arm group label: Percutaneous cholecystomy
arm group type: Active Comparator
intervention type: Procedure
intervention name: EUS-guided gallbladder drainage (EGBD)
description: The gallbladder would be identified by a linear echoendoscope (EUS) and a suitable puncture site in the stomach or the duodenum without intervening blood vessels would be located. The gallbladder would be punctured with a 19-gauge needle and a guidewire would be passed through the needle and looped in the gallbladder. The Hot AXIOS stent would then be inserted. A naso-gallbladder drain or a 5-7Fr double pigtail stents can be inserted into gallbladder if the effluent failed to clear after irrigation. This would be performed to improve drainage and avoid obstruction of the stent.
arm group label: EUS-guided gallbladder drainage
intervention type: Procedure
intervention name: Percutaneous cholecystostomy (PC)
description: Trained interventional radiologists in the respective hospitals would perform the procedure under local anesthesia. A transhepatic route would be used in all patients to decrease bile leakage. An 8.5 Fr pigtail drainage catheter would be placed between the 8th or 9th intercostal space under sonographic and fluoroscopic guidance. The pigtail catheter would be drained to a bedside bag.
arm group label: Percutaneous cholecystomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: China
country: Japan
country: Spain
citation: de la Serna-Higuera C, Perez-Miranda M, Gil-Simon P, Ruiz-Zorrilla R, Diez-Redondo P, Alcaide N, Sancho-del Val L, Nunez-Rodriguez H. EUS-guided transenteric gallbladder drainage with a new fistula-forming, lumen-apposing metal stent. Gastrointest Endosc. 2013 Feb;77(2):303-8. doi: 10.1016/j.gie.2012.09.021. Epub 2012 Dec 1. No abstract available.
PMID: 23206813
citation: Itoi T, Binmoeller KF, Shah J, Sofuni A, Itokawa F, Kurihara T, Tsuchiya T, Ishii K, Tsuji S, Ikeuchi N, Moriyasu F. Clinical evaluation of a novel lumen-apposing metal stent for endosonography-guided pancreatic pseudocyst and gallbladder drainage (with videos). Gastrointest Endosc. 2012 Apr;75(4):870-6. doi: 10.1016/j.gie.2011.10.020. Epub 2012 Jan 31.
PMID: 22301347
citation: Teoh AY, Binmoeller KF, Lau JY. Single-step EUS-guided puncture and delivery of a lumen-apposing stent for gallbladder drainage using a novel cautery-tipped stent delivery system. Gastrointest Endosc. 2014 Dec;80(6):1171. doi: 10.1016/j.gie.2014.03.038. Epub 2014 May 13. No abstract available.
PMID: 24830582
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Anthony Teoh
investigator title: Honorary Associate Professor
mesh term: Cholecystitis
mesh term: Acalculous Cholecystitis
mesh term: Cholecystitis, Acute