xml: <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/NCT06038201</url>
    </required_header>
    <id_info>
      <org_study_id>IECED-10022023</org_study_id>
      <nct_id>NCT06038201</nct_id>
    </id_info>
    <brief_title>Cholecystectomy vs EUS-guided GBD With Stone Removal</brief_title>
    <official_title>Cholelithiasis Management: Elective Laparoscopic Cholecystectomy vs EUS-guided Gallbladder Cholecystostomy for Gallstones Clearance</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Instituto Ecuatoriano de Enfermedades Digestivas</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Instituto Ecuatoriano de Enfermedades Digestivas</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In this new era of less invasive procedures, the indications for endoscopic ultrasound&#xD;
        (EUS)-guided gallbladder drainage (GBD) are rapidly expanding. Nowadays, the standard&#xD;
        treatment for uncomplicated cholelithiasis (symptomatic patients not requiring hospital&#xD;
        admission or non-surgically managed during one or more hospital admissions) is elective&#xD;
        laparoscopic cholecystectomy.&#xD;
  &#xD;
        To avoid the complications, difficulties and disadvantages of cholecystectomy, the&#xD;
        investigators proposed a single-center study to determine the safety and effectiveness of&#xD;
        EUS-guided GBD with electrocautery-enhanced lumen-apposing metal stent (LAMS) (Boston&#xD;
        Scientific, Marlborough, MA, EEUU) with stone removal in patients with cholelithiasis, in&#xD;
        comparison with the gold standard treatment, the elective laparoscopic cholecystectomy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Currently, elective laparoscopic cholecystectomy (LC), is the preferred management for&#xD;
        cholelithiasis in patients with history of gallstones-related adverse events, increased risk&#xD;
        for gallbladder cancer, or recurrent typical biliary colic. Although elective LC is a&#xD;
        commonly performed surgery, the incidence of serious adverse events is around 2.6%. Also,&#xD;
        post-cholecystectomy syndrome, alkaline reflux gastritis and bile duct injury are chronic and&#xD;
        feared adverse events secondary to gallbladder removal. To avoid them, a more conservative&#xD;
        approach need to be address. The preservation of the gallbladder permits the conservation of&#xD;
        its physiological functions, preventing LC adverse events, with potential less recovery time.&#xD;
  &#xD;
        In this scenario, the endoscopic ultrasound (EUS) with lumen-apposing metal stent&#xD;
        (LAMS)-assisted cholecystostomy for gallstones clearance has gained popularity due its trend&#xD;
        toward an improved safety profile. The increased on advanced endoscopy experience along with&#xD;
        the development of new stents, tools, and delivery systems, had placed the EUS-guided&#xD;
        cholecystostomy as a plausible alternative to elective LC for acute cholecystitis, high-risk&#xD;
        surgical patients, or patients with a concomitant bile duct neoplasia. In those contexts,&#xD;
        EUS-guided cholecystostomy has demonstrated similar or even less hospitalization length of&#xD;
        stays, adverse events, readmissions and reinterventions in comparison with elective LC or&#xD;
        percutaneous drainage, respectively. Thus, the feasibility of EUS-guided cholecystostomy for&#xD;
        cholelithiasis deserves to be explored.&#xD;
  &#xD;
        This study pursues to compare between the effectiveness and safety of EUS-guided&#xD;
        cholecystostomy and the elective laparoscopic cholecystectomy through an interventional, two&#xD;
        group assignment, controlled trial.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2, 2023</start_date>
    <completion_date type="Anticipated">November 2, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 2, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>A controlled, non-inferiority prospective trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Technical success after surgical and endoscopic intervention</measure>
      <time_frame>Up to 6 hours</time_frame>
      <description>Number of patients with correct placement LAMS or uneventful competition of laparoscopic cholecystectomy along with stone clearance.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Resolution of biliary symptoms</measure>
      <time_frame>up to 12 months</time_frame>
      <description>Number of patients with clinical resolution based in a questionnaire for the assessment of biliary symptoms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adverse events after the surgical procedures</measure>
      <time_frame>up to 14 days</time_frame>
      <description>The post-surgical adverse events will be assessed by the Clavien-Dindo classification</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adverse events after the endoscopic procedures</measure>
      <time_frame>Up to 14 days</time_frame>
      <description>The post-endoscopic adverse events will be assessed by the Adverse Events Gastrointestinal Endoscopy (AGREE) Classification</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>30-day major complications assessment</measure>
      <time_frame>up to 30 days</time_frame>
      <description>To assess the safety of the procedures the investigators will consider the 30-day major complication rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Re-intervention rate</measure>
      <time_frame>12-month follow-up</time_frame>
      <description>Number of patients that requires a re-intervention after an endoscopic or surgical procedure</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">56</enrollment>
    <condition>Cholelithiasis</condition>
    <arm_group>
      <arm_group_label>EUS-GBD with stone clearance</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients &gt;18-year-old with a diagnosis of gallstones by abdominal ultrasound, will be randomly allocated to EUS-guided GBD with electrocautery-enhanced lumen-apposing metal stent (LAMS) (Boston Scientific, Marlborough, MA, EEUU) with stone clearance.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Elective laparoscopic cholecystectomy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients &gt;18-year-old with a diagnosis of gallstones by abdominal ultrasound are randomly allocated to elective laparoscopic cholecystectomy and laparoscopic biliary exploration.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>LAMS placement for cholecystostomy</intervention_name>
      <description>The EUS-guided cholecystostomy entails placing a 10 mm x 10 mm or 10mm x 15mm Electrocautery-Enhanced LAMS for direct cholecystoscopy with a transnasal gastroscope. Then, the cholecystostomy will be performed with an echoendoscope, assisted by fluoroscopy to allow the puncturing of the gallbladder form either the duodenal bulb (cholecysto-duodenoscopy) or the gastric antrum (cholecysto-gastrostomy). Subsequently, from the most optimal anatomic point it will be tutored with a 10mmx10mm or 10mm x 15mm LAMS to create anastomosis between the structures. Then, the stone clearance will be performed by endoscopy (basket catheters) or by cholangioscopy (mechanical lithotripsy with or without basket catheters).</description>
      <arm_group_label>EUS-GBD with stone clearance</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Laparoscopic cholecystectomy</intervention_name>
      <description>A laparoscopic biliary exploration along with an elective laparoscopic cholecystectomy will be performed by experienced laparoscopic surgeons (over 100 laparoscopic procedures yearly) by three or four-trocar technique with transection of the cystic duct and artery.</description>
      <arm_group_label>Elective laparoscopic cholecystectomy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults &gt;18 years old and &lt;89 years old&#xD;
  &#xD;
            -  Adult symptomatic patients with gallstones documented by US&#xD;
  &#xD;
            -  Subject is a suitable candidate for an elective laparoscopic cholecystectomy or an&#xD;
               EUS-guided GBD&#xD;
  &#xD;
            -  Patients or authorized representative give informed consent for endoscopic or surgical&#xD;
               approach&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with hepato-pancreato-biliary diseases other than gallstones (tumors,&#xD;
               obstructions, inflammation)&#xD;
  &#xD;
            -  Patients with acute cholecystitis, cholangitis or choledocholithiasis.&#xD;
  &#xD;
            -  Patients with gallbladder polyps, family history of gallbladder cancer, or any other&#xD;
               high-risk factor for gallbladder cancer&#xD;
  &#xD;
            -  Patient unable to give informed consent or refuse to participate.&#xD;
  &#xD;
            -  Prior biliary intervention&#xD;
  &#xD;
            -  Pregnancy or nursing&#xD;
  &#xD;
            -  Any other medical condition that contraindicates surgical or endoscopic procedures&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>89 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Carlos Robles-Medranda, MD, FASGE</last_name>
      <role>Principal Investigator</role>
      <affiliation>Instituto Ecuatoriano de Enfermedades Digestivas</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Carlos Robles-Medranda, MD, FASGE</last_name>
      <phone>+59342109180</phone>
      <email>carlosoakm@yahoo.es</email>
    </overall_contact>
    <location>
      <facility>
        <name>Instituto Ecuatoriano de Enfermedades Digestivas</name>
        <address>
          <city>Guayaquil</city>
          <state>Guayas</state>
          <zip>090505</zip>
          <country>Ecuador</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Ecuador</country>
    </location_countries>
    <reference>
      <citation>Kamarajah SK, Karri S, Bundred JR, Evans RPT, Lin A, Kew T, Ekeozor C, Powell SL, Singh P, Griffiths EA. Perioperative outcomes after laparoscopic cholecystectomy in elderly patients: a systematic review and meta-analysis. Surg Endosc. 2020 Nov;34(11):4727-4740. doi: 10.1007/s00464-020-07805-z. Epub 2020 Jul 13.</citation>
      <PMID>32661706</PMID>
    </reference>
    <reference>
      <citation>Radlinski MJ, Strand DS, Shami VM. Evolution of interventional endoscopic ultrasound. Gastroenterol Rep (Oxf). 2023 Jun 30;11:goad038. doi: 10.1093/gastro/goad038. eCollection 2023.</citation>
      <PMID>37398926</PMID>
    </reference>
    <reference>
      <citation>Radunovic M, Lazovic R, Popovic N, Magdelinic M, Bulajic M, Radunovic L, Vukovic M, Radunovic M. Complications of Laparoscopic Cholecystectomy: Our Experience from a Retrospective Analysis. Open Access Maced J Med Sci. 2016 Dec 15;4(4):641-646. doi: 10.3889/oamjms.2016.128. Epub 2016 Nov 9.</citation>
      <PMID>28028405</PMID>
    </reference>
    <reference>
      <citation>Du QC, Wang YY, Hu CL, Zhou Y. Reconsideration of indications for choledochoscopic gallbladder-preserving surgery and preventive measures for postoperative recurrence of gallstones. Wideochir Inne Tech Maloinwazyjne. 2020 Mar;15(1):87-96. doi: 10.5114/wiitm.2019.88647. Epub 2019 Oct 17.</citation>
      <PMID>32117490</PMID>
    </reference>
    <reference>
      <citation>Flynn DJ, Memel Z, Hernandez-Barco Y, Visrodia KH, Casey BW, Krishnan K. Outcomes of EUS-guided transluminal gallbladder drainage in patients without cholecystitis. Endosc Ultrasound. 2021 Sep-Oct;10(5):381-386. doi: 10.4103/EUS-D-21-00040.</citation>
      <PMID>34677160</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Instituto Ecuatoriano de Enfermedades Digestivas</investigator_affiliation>
      <investigator_full_name>Carlos Robles-Medranda</investigator_full_name>
      <investigator_title>Head of Endoscopy Division</investigator_title>
    </responsible_party>
    <keyword>Cholelithiasis</keyword>
    <keyword>biliary</keyword>
    <keyword>cholecystostomy</keyword>
    <keyword>laparoscopic</keyword>
    <keyword>cholecystectomy</keyword>
    <keyword>gallstones</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gallstones</mesh_term>
      <mesh_term>Cholelithiasis</mesh_term>
      <mesh_term>Cholecystolithiasis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06038201
  org study id: IECED-10022023
  nct id: NCT06038201
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  In this new era of less invasive procedures, the indications for endoscopic ultrasound
        (EUS)-guided gallbladder drainage (GBD) are rapidly expanding. Nowadays, the standard
        treatment for uncomplicated cholelithiasis (symptomatic patients not requiring hospital
        admission or non-surgically managed during one or more hospital admissions) is elective
        laparoscopic cholecystectomy.
  
        To avoid the complications, difficulties and disadvantages of cholecystectomy, the
        investigators proposed a single-center study to determine the safety and effectiveness of
        EUS-guided GBD with electrocautery-enhanced lumen-apposing metal stent (LAMS) (Boston
        Scientific, Marlborough, MA, EEUU) with stone removal in patients with cholelithiasis, in
        comparison with the gold standard treatment, the elective laparoscopic cholecystectomy.
  Currently, elective laparoscopic cholecystectomy (LC), is the preferred management for
        cholelithiasis in patients with history of gallstones-related adverse events, increased risk
        for gallbladder cancer, or recurrent typical biliary colic. Although elective LC is a
        commonly performed surgery, the incidence of serious adverse events is around 2.6%. Also,
        post-cholecystectomy syndrome, alkaline reflux gastritis and bile duct injury are chronic and
        feared adverse events secondary to gallbladder removal. To avoid them, a more conservative
        approach need to be address. The preservation of the gallbladder permits the conservation of
        its physiological functions, preventing LC adverse events, with potential less recovery time.
  
        In this scenario, the endoscopic ultrasound (EUS) with lumen-apposing metal stent
        (LAMS)-assisted cholecystostomy for gallstones clearance has gained popularity due its trend
        toward an improved safety profile. The increased on advanced endoscopy experience along with
        the development of new stents, tools, and delivery systems, had placed the EUS-guided
        cholecystostomy as a plausible alternative to elective LC for acute cholecystitis, high-risk
        surgical patients, or patients with a concomitant bile duct neoplasia. In those contexts,
        EUS-guided cholecystostomy has demonstrated similar or even less hospitalization length of
        stays, adverse events, readmissions and reinterventions in comparison with elective LC or
        percutaneous drainage, respectively. Thus, the feasibility of EUS-guided cholecystostomy for
        cholelithiasis deserves to be explored.
  
        This study pursues to compare between the effectiveness and safety of EUS-guided
        cholecystostomy and the elective laparoscopic cholecystectomy through an interventional, two
        group assignment, controlled trial.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: A controlled, non-inferiority prospective trial
  primary purpose: Treatment
  masking: Single (Investigator)
  measure: Technical success after surgical and endoscopic intervention
  time frame: Up to 6 hours
  description: Number of patients with correct placement LAMS or uneventful competition of laparoscopic cholecystectomy along with stone clearance.
  measure: Resolution of biliary symptoms
  time frame: up to 12 months
  description: Number of patients with clinical resolution based in a questionnaire for the assessment of biliary symptoms.
  measure: Adverse events after the surgical procedures
  time frame: up to 14 days
  description: The post-surgical adverse events will be assessed by the Clavien-Dindo classification
  measure: Adverse events after the endoscopic procedures
  time frame: Up to 14 days
  description: The post-endoscopic adverse events will be assessed by the Adverse Events Gastrointestinal Endoscopy (AGREE) Classification
  measure: 30-day major complications assessment
  time frame: up to 30 days
  description: To assess the safety of the procedures the investigators will consider the 30-day major complication rate
  measure: Re-intervention rate
  time frame: 12-month follow-up
  description: Number of patients that requires a re-intervention after an endoscopic or surgical procedure
  arm group label: EUS-GBD with stone clearance
  arm group type: Experimental
  description: Patients >18-year-old with a diagnosis of gallstones by abdominal ultrasound, will be randomly allocated to EUS-guided GBD with electrocautery-enhanced lumen-apposing metal stent (LAMS) (Boston Scientific, Marlborough, MA, EEUU) with stone clearance.
  arm group label: Elective laparoscopic cholecystectomy
  arm group type: Active Comparator
  description: Patients >18-year-old with a diagnosis of gallstones by abdominal ultrasound are randomly allocated to elective laparoscopic cholecystectomy and laparoscopic biliary exploration.
  intervention type: Procedure
  intervention name: LAMS placement for cholecystostomy
  description: The EUS-guided cholecystostomy entails placing a 10 mm x 10 mm or 10mm x 15mm Electrocautery-Enhanced LAMS for direct cholecystoscopy with a transnasal gastroscope. Then, the cholecystostomy will be performed with an echoendoscope, assisted by fluoroscopy to allow the puncturing of the gallbladder form either the duodenal bulb (cholecysto-duodenoscopy) or the gastric antrum (cholecysto-gastrostomy). Subsequently, from the most optimal anatomic point it will be tutored with a 10mmx10mm or 10mm x 15mm LAMS to create anastomosis between the structures. Then, the stone clearance will be performed by endoscopy (basket catheters) or by cholangioscopy (mechanical lithotripsy with or without basket catheters).
  arm group label: EUS-GBD with stone clearance
  intervention type: Procedure
  intervention name: Laparoscopic cholecystectomy
  description: A laparoscopic biliary exploration along with an elective laparoscopic cholecystectomy will be performed by experienced laparoscopic surgeons (over 100 laparoscopic procedures yearly) by three or four-trocar technique with transection of the cystic duct and artery.
  arm group label: Elective laparoscopic cholecystectomy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 89 Years
  healthy volunteers: No
  last name: Carlos Robles-Medranda, MD, FASGE
  role: Principal Investigator
  affiliation: Instituto Ecuatoriano de Enfermedades Digestivas
  last name: Carlos Robles-Medranda, MD, FASGE
  phone: +59342109180
  email: carlosoakm@yahoo.es
  facility: 
  country: Ecuador
  citation: Kamarajah SK, Karri S, Bundred JR, Evans RPT, Lin A, Kew T, Ekeozor C, Powell SL, Singh P, Griffiths EA. Perioperative outcomes after laparoscopic cholecystectomy in elderly patients: a systematic review and meta-analysis. Surg Endosc. 2020 Nov;34(11):4727-4740. doi: 10.1007/s00464-020-07805-z. Epub 2020 Jul 13.
  PMID: 32661706
  citation: Radlinski MJ, Strand DS, Shami VM. Evolution of interventional endoscopic ultrasound. Gastroenterol Rep (Oxf). 2023 Jun 30;11:goad038. doi: 10.1093/gastro/goad038. eCollection 2023.
  PMID: 37398926
  citation: Radunovic M, Lazovic R, Popovic N, Magdelinic M, Bulajic M, Radunovic L, Vukovic M, Radunovic M. Complications of Laparoscopic Cholecystectomy: Our Experience from a Retrospective Analysis. Open Access Maced J Med Sci. 2016 Dec 15;4(4):641-646. doi: 10.3889/oamjms.2016.128. Epub 2016 Nov 9.
  PMID: 28028405
  citation: Du QC, Wang YY, Hu CL, Zhou Y. Reconsideration of indications for choledochoscopic gallbladder-preserving surgery and preventive measures for postoperative recurrence of gallstones. Wideochir Inne Tech Maloinwazyjne. 2020 Mar;15(1):87-96. doi: 10.5114/wiitm.2019.88647. Epub 2019 Oct 17.
  PMID: 32117490
  citation: Flynn DJ, Memel Z, Hernandez-Barco Y, Visrodia KH, Casey BW, Krishnan K. Outcomes of EUS-guided transluminal gallbladder drainage in patients without cholecystitis. Endosc Ultrasound. 2021 Sep-Oct;10(5):381-386. doi: 10.4103/EUS-D-21-00040.
  PMID: 34677160
  responsible party type: Principal Investigator
  investigator affiliation: Instituto Ecuatoriano de Enfermedades Digestivas
  investigator full name: Carlos Robles-Medranda
  investigator title: Head of Endoscopy Division
  mesh term: Gallstones
  mesh term: Cholelithiasis
  mesh term: Cholecystolithiasis
  sharing ipd: No