<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/NCT02196935</url>
  </required_header>
  <id_info>
    <org_study_id>HS-10-00369</org_study_id>
    <nct_id>NCT02196935</nct_id>
  </id_info>
  <brief_title>Los Angeles Prospective GI Biliary and EUS Series</brief_title>
  <official_title>Prospective Evaluation of Pancreatic, Biliary, and Gastrointestinal Neoplasia by Endoscopic Retrograde Cholangiopancreatography (ERCP) and Endoscopic Ultrasound (EUS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Southern California</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>
      Endoscopic retrograde cholangiopancreatography and endoscopic ultrasound are increasingly&#xD;
      being used to manage complex disease of the bile duct, pancreas and cancer. Gastroenterology&#xD;
      patients at the Los Angeles County Hospital presents a unique and diverse patient population.&#xD;
&#xD;
      Our aim is to study the biochemical, radiographic, and clinical predictors of bile duct&#xD;
      stones. Exploratory aims include the study of the management of cholangitis, bile leaks, GI&#xD;
      cancer diagnosis and management, and the management of pancreaticobiliary problems in the&#xD;
      underserved.&#xD;
&#xD;
      All patients managed by EUS or ERCP at the LA County &amp; USC University Hospitals will be&#xD;
      enrolled in the databaseThe timing, clinical presentation, and objective details of patient&#xD;
      presentation are recorded prospectively. Additionally the results of the subsequent ERCP and&#xD;
      EUS procedures. Subsequent, clinical course and pathology will also be recorded.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      AIMS A) Characterize unusual disease and pathologic presentations which require endoscopic&#xD;
      treatment in a large safety net hospital B) To study the impact of EUS and ERCP on the&#xD;
      management of these patients. C) Analyze how EUS and ERCP results correlate with other&#xD;
      radiographic methods including conventional ultrasound and computed tomography (CT) D)&#xD;
      Compare role of EUS and ERCP in a safety net versus tertiary care center&#xD;
&#xD;
      II) BACKGROUND Endscopic Ultrasound (EUS) which consists of an endoscope containing a high&#xD;
      frequency transducer, has become standard of care to evaluate gastrointestinal cancer as well&#xD;
      as diseases included chronic pancreatitis. EUS with fine needle aspiration (FNA) has been&#xD;
      demonstrated to be the least invasive and most effective means to acquire tissue in a number&#xD;
      of situations included pancreas cancer and maligant lymph nodes. Endoscopic Retrograde&#xD;
      Cholangiopancreatography (ERCP) is a therapeutic procedure used to manage&#xD;
      choledocholithiasis, bile duct obstruction and occasional pancreatic ductal problems. Its&#xD;
      diagostic uses are now more limited with the advent of EUS and cross sectional radiographic&#xD;
      studies including CT and magnetic resonance cholangiopancreatography (MRCP).&#xD;
&#xD;
      A number of leading ERCP/EUS groups including those at the University of Alabama (Birmingham,&#xD;
      Alabama), the Cleveland Clinic (Cleveland Ohio) and the Mayo Clinic (Rochester, Minnesota)&#xD;
      have developed ERCP/EUS databases which have led to important insight about the role of these&#xD;
      procedure and the diseases they are used to manage. However, these groups and indeed almost&#xD;
      the entire world literature regarding EUS and ERCP focuses on America, Western European, and&#xD;
      Japanese populations.&#xD;
&#xD;
      The goal of this database will be to study the impact of EUS and ERCP on an underserved&#xD;
      population at LAC. The prevalence of certain diseases including cholangitis, large bile duct&#xD;
      stones, and gastric cancer are markedly higher at our institution than in other western&#xD;
      facilities presenting a unique opportunity to report how they are treated as part of standard&#xD;
      management.&#xD;
&#xD;
      IIIA) DESIGN AND METHODOLOGY&#xD;
&#xD;
        1. ALL PROCEDURES ARE DONE STRICTLY AS STANDARD OF CARE.&#xD;
&#xD;
        2. Detailed collection sheets containing no PHI but with detailed information about&#xD;
           laboratories, symptoms, radiographic tests, time of presentation and procedure detals&#xD;
           are prospectively completed for patients undergoing EUS or ERCP by the Gastroenterology&#xD;
           service at the USC Hospitals. The resulting pathology and clinical course are collected&#xD;
           on these anonymized forms.&#xD;
&#xD;
        3. The information in the extraction sheets is entered into a database stripped of all&#xD;
           personal health identifiers.&#xD;
&#xD;
      IIIB) PLANNED DATA COLLECTION&#xD;
&#xD;
        1. The aim of this project will be to develop a prospective database of EUS/ERCP cases at&#xD;
           USC.&#xD;
&#xD;
        2. For both ERCP and EUS cases detailed information regarding the presentation of the&#xD;
           patients will be noted. Specifically, which radiographic and biochemical markers and&#xD;
           clinical symptoms are of interest.&#xD;
&#xD;
      4) For EUS the outcomes include the confirmation by biopsies and imaging of the underlying&#xD;
      pathology.&#xD;
&#xD;
      5) For ERCP the outcomes are procedural success and more specifically bile duct stone&#xD;
      confirmation and removal, treatment of cholangitis, treatment of leaks biliary, and&#xD;
      decompression of obstruction. Success of anesthesia strategy is an aim of the collection.&#xD;
&#xD;
      6) For potential quality of care assessment procedure complications and success of anesthesia&#xD;
      strategy are a priori areas of study&#xD;
&#xD;
      IV) STATISTICAL CONSIDERATIONS As this study involves creation of a database of standard of&#xD;
      care management of patients by EUS and ERCP primarily descriptive statistics will be used in&#xD;
      future studies. If individual groups are compared (ie those with positive versus atypical&#xD;
      fine needle aspiration) chi squared versus t statistic will be used for analysis depending on&#xD;
      distribution..&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>September 2010</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2025</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Successful ERCP or EUS</measure>
    <time_frame>1 year</time_frame>
    <description>Completed ERCP or EUS in which objectives of procedure were met.Unsuccessful ERCP will be classified as secondary to technical (such as failed cannulation or stent placement) versus sedation failure in which patient could not be sedated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bile Duct Stone</measure>
    <time_frame>1 year</time_frame>
    <description>Definite bile duct stone confirmed by cholangiogram</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Hospitalization</measure>
    <time_frame>1 year</time_frame>
    <description>Duration of hospitalization from presentation to the emergency department to discharge or death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Definitive Diagnosis</measure>
    <time_frame>1 year</time_frame>
    <description>Pathologic diagnosis which enables definitive treatment plan, answer</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">2500</enrollment>
  <condition>Biliary Disease</condition>
  <condition>Pancreatitis</condition>
  <condition>Gastrointestinal Neoplasms</condition>
  <arm_group>
    <arm_group_label>ERCP/EUS</arm_group_label>
    <description>All patients who undergo ERCP and EUS for clinical indications will undergo a detailed prospective assessment of clinical course.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>clinical course</intervention_name>
    <description>Detailed presentation including labs, demographics, imaging of those who undergo ERCP/EUS with be prospectively recorded. Details of procedure including sedation strategy and success will be collected. Results of procedure including final pathology results with be recorded.</description>
    <arm_group_label>ERCP/EUS</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients undergoing ERCP or EUS for clinical indications&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients undergoing EUS or ERCP at LAC, UH, and Norris Cancer Hospitals as&#xD;
             standard of clinical care will be enrolled.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None of the patients will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James L Buxbaum, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>James Buxbaum, MD</last_name>
    <phone>3234096939</phone>
    <email>jbuxbaum@usc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maria Trujillo</last_name>
    <phone>3234096939</phone>
    <email>mit@usc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Los Angeles County Hospital</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>91030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Trujillo</last_name>
      <phone>323-409-6939</phone>
      <email>mit@usc.edu</email>
    </contact>
    <investigator>
      <last_name>James Buxbaum, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Singh S, Purohit T, Aoun E, Patel Y, Carleton N, Mitre M, Morrissey S, Dhawan M, Thakkar S. Comparison of the outcomes of endoscopic ultrasound based on community hospital versus tertiary academic center settings. Dig Dis Sci. 2014 Aug;59(8):1925-30. doi: 10.1007/s10620-014-3075-9. Epub 2014 Feb 27.</citation>
    <PMID>24573718</PMID>
  </reference>
  <reference>
    <citation>Mehta PP, Vargo JJ, Dumot JA, Parsi MA, Lopez R, Zuccaro G. Does anesthesiologist-directed sedation for ERCP improve deep cannulation and complication rates? Dig Dis Sci. 2011 Jul;56(7):2185-90. doi: 10.1007/s10620-011-1568-3. Epub 2011 Jan 28.</citation>
    <PMID>21274625</PMID>
  </reference>
  <reference>
    <citation>Vargo JJ, Zuccaro G Jr, Dumot JA, Shermock KM, Morrow JB, Conwell DL, Trolli PA, Maurer WG. Gastroenterologist-administered propofol versus meperidine and midazolam for advanced upper endoscopy: a prospective, randomized trial. Gastroenterology. 2002 Jul;123(1):8-16. doi: 10.1053/gast.2002.34232.</citation>
    <PMID>12105827</PMID>
  </reference>
  <reference>
    <citation>Khashab MA, Tariq A, Tariq U, Kim K, Ponor L, Lennon AM, Canto MI, Gurakar A, Yu Q, Dunbar K, Hutfless S, Kalloo AN, Singh VK. Delayed and unsuccessful endoscopic retrograde cholangiopancreatography are associated with worse outcomes in patients with acute cholangitis. Clin Gastroenterol Hepatol. 2012 Oct;10(10):1157-61. doi: 10.1016/j.cgh.2012.03.029. Epub 2012 Apr 13.</citation>
    <PMID>22507875</PMID>
  </reference>
  <reference>
    <citation>Navaneethan U, Gutierrez NG, Jegadeesan R, Venkatesh PG, Butt M, Sanaka MR, Vargo JJ, Parsi MA. Delay in performing ERCP and adverse events increase the 30-day readmission risk in patients with acute cholangitis. Gastrointest Endosc. 2013 Jul;78(1):81-90. doi: 10.1016/j.gie.2013.02.003. Epub 2013 Mar 23.</citation>
    <PMID>23528654</PMID>
  </reference>
  <reference>
    <citation>Barkun AN, Barkun JS, Fried GM, Ghitulescu G, Steinmetz O, Pham C, Meakins JL, Goresky CA. Useful predictors of bile duct stones in patients undergoing laparoscopic cholecystectomy. McGill Gallstone Treatment Group. Ann Surg. 1994 Jul;220(1):32-9. doi: 10.1097/00000658-199407000-00006.</citation>
    <PMID>7517657</PMID>
  </reference>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>July 19, 2014</study_first_submitted>
  <study_first_submitted_qc>July 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>June 14, 2022</last_update_submitted>
  <last_update_submitted_qc>June 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>James Buxbaum</investigator_full_name>
    <investigator_title>Director of Endoscopy, Los Angeles County Hospital</investigator_title>
  </responsible_party>
  <keyword>Cholangitis</keyword>
  <keyword>Choledocholithiasis</keyword>
  <keyword>Gastrointestinal Neoplasms</keyword>
  <keyword>Medically underserved area</keyword>
  <keyword>Anesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Neoplasms</mesh_term>
    <mesh_term>Digestive System Neoplasms</mesh_term>
    <mesh_term>Pancreatitis</mesh_term>
    <mesh_term>Gallbladder Diseases</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/NCT02196935
org study id: HS-10-00369
nct id: NCT02196935
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Endoscopic retrograde cholangiopancreatography and endoscopic ultrasound are increasingly
      being used to manage complex disease of the bile duct, pancreas and cancer. Gastroenterology
      patients at the Los Angeles County Hospital presents a unique and diverse patient population.

      Our aim is to study the biochemical, radiographic, and clinical predictors of bile duct
      stones. Exploratory aims include the study of the management of cholangitis, bile leaks, GI
      cancer diagnosis and management, and the management of pancreaticobiliary problems in the
      underserved.

      All patients managed by EUS or ERCP at the LA County & USC University Hospitals will be
      enrolled in the databaseThe timing, clinical presentation, and objective details of patient
      presentation are recorded prospectively. Additionally the results of the subsequent ERCP and
      EUS procedures. Subsequent, clinical course and pathology will also be recorded.
AIMS A) Characterize unusual disease and pathologic presentations which require endoscopic
      treatment in a large safety net hospital B) To study the impact of EUS and ERCP on the
      management of these patients. C) Analyze how EUS and ERCP results correlate with other
      radiographic methods including conventional ultrasound and computed tomography (CT) D)
      Compare role of EUS and ERCP in a safety net versus tertiary care center

      II) BACKGROUND Endscopic Ultrasound (EUS) which consists of an endoscope containing a high
      frequency transducer, has become standard of care to evaluate gastrointestinal cancer as well
      as diseases included chronic pancreatitis. EUS with fine needle aspiration (FNA) has been
      demonstrated to be the least invasive and most effective means to acquire tissue in a number
      of situations included pancreas cancer and maligant lymph nodes. Endoscopic Retrograde
      Cholangiopancreatography (ERCP) is a therapeutic procedure used to manage
      choledocholithiasis, bile duct obstruction and occasional pancreatic ductal problems. Its
      diagostic uses are now more limited with the advent of EUS and cross sectional radiographic
      studies including CT and magnetic resonance cholangiopancreatography (MRCP).

      A number of leading ERCP/EUS groups including those at the University of Alabama (Birmingham,
      Alabama), the Cleveland Clinic (Cleveland Ohio) and the Mayo Clinic (Rochester, Minnesota)
      have developed ERCP/EUS databases which have led to important insight about the role of these
      procedure and the diseases they are used to manage. However, these groups and indeed almost
      the entire world literature regarding EUS and ERCP focuses on America, Western European, and
      Japanese populations.

      The goal of this database will be to study the impact of EUS and ERCP on an underserved
      population at LAC. The prevalence of certain diseases including cholangitis, large bile duct
      stones, and gastric cancer are markedly higher at our institution than in other western
      facilities presenting a unique opportunity to report how they are treated as part of standard
      management.

      IIIA) DESIGN AND METHODOLOGY

        1. ALL PROCEDURES ARE DONE STRICTLY AS STANDARD OF CARE.

        2. Detailed collection sheets containing no PHI but with detailed information about
           laboratories, symptoms, radiographic tests, time of presentation and procedure detals
           are prospectively completed for patients undergoing EUS or ERCP by the Gastroenterology
           service at the USC Hospitals. The resulting pathology and clinical course are collected
           on these anonymized forms.

        3. The information in the extraction sheets is entered into a database stripped of all
           personal health identifiers.

      IIIB) PLANNED DATA COLLECTION

        1. The aim of this project will be to develop a prospective database of EUS/ERCP cases at
           USC.

        2. For both ERCP and EUS cases detailed information regarding the presentation of the
           patients will be noted. Specifically, which radiographic and biochemical markers and
           clinical symptoms are of interest.

      4) For EUS the outcomes include the confirmation by biopsies and imaging of the underlying
      pathology.

      5) For ERCP the outcomes are procedural success and more specifically bile duct stone
      confirmation and removal, treatment of cholangitis, treatment of leaks biliary, and
      decompression of obstruction. Success of anesthesia strategy is an aim of the collection.

      6) For potential quality of care assessment procedure complications and success of anesthesia
      strategy are a priori areas of study

      IV) STATISTICAL CONSIDERATIONS As this study involves creation of a database of standard of
      care management of patients by EUS and ERCP primarily descriptive statistics will be used in
      future studies. If individual groups are compared (ie those with positive versus atypical
      fine needle aspiration) chi squared versus t statistic will be used for analysis depending on
      distribution..
observational model: Cohort
time perspective: Prospective
measure: Successful ERCP or EUS
time frame: 1 year
description: Completed ERCP or EUS in which objectives of procedure were met.Unsuccessful ERCP will be classified as secondary to technical (such as failed cannulation or stent placement) versus sedation failure in which patient could not be sedated.
measure: Bile Duct Stone
time frame: 1 year
description: Definite bile duct stone confirmed by cholangiogram
measure: Length of Hospitalization
time frame: 1 year
description: Duration of hospitalization from presentation to the emergency department to discharge or death.
measure: Definitive Diagnosis
time frame: 1 year
description: Pathologic diagnosis which enables definitive treatment plan, answer
arm group label: ERCP/EUS
description: All patients who undergo ERCP and EUS for clinical indications will undergo a detailed prospective assessment of clinical course.
intervention type: Other
intervention name: clinical course
description: Detailed presentation including labs, demographics, imaging of those who undergo ERCP/EUS with be prospectively recorded. Details of procedure including sedation strategy and success will be collected. Results of procedure including final pathology results with be recorded.
arm group label: ERCP/EUS
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: James L Buxbaum, MD
role: Principal Investigator
affiliation: University of Southern California School of Medicine
last name: James Buxbaum, MD
phone: 3234096939
email: jbuxbaum@usc.edu
last name: Maria Trujillo
phone: 3234096939
email: mit@usc.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
citation: Singh S, Purohit T, Aoun E, Patel Y, Carleton N, Mitre M, Morrissey S, Dhawan M, Thakkar S. Comparison of the outcomes of endoscopic ultrasound based on community hospital versus tertiary academic center settings. Dig Dis Sci. 2014 Aug;59(8):1925-30. doi: 10.1007/s10620-014-3075-9. Epub 2014 Feb 27.
PMID: 24573718
citation: Mehta PP, Vargo JJ, Dumot JA, Parsi MA, Lopez R, Zuccaro G. Does anesthesiologist-directed sedation for ERCP improve deep cannulation and complication rates? Dig Dis Sci. 2011 Jul;56(7):2185-90. doi: 10.1007/s10620-011-1568-3. Epub 2011 Jan 28.
PMID: 21274625
citation: Vargo JJ, Zuccaro G Jr, Dumot JA, Shermock KM, Morrow JB, Conwell DL, Trolli PA, Maurer WG. Gastroenterologist-administered propofol versus meperidine and midazolam for advanced upper endoscopy: a prospective, randomized trial. Gastroenterology. 2002 Jul;123(1):8-16. doi: 10.1053/gast.2002.34232.
PMID: 12105827
citation: Khashab MA, Tariq A, Tariq U, Kim K, Ponor L, Lennon AM, Canto MI, Gurakar A, Yu Q, Dunbar K, Hutfless S, Kalloo AN, Singh VK. Delayed and unsuccessful endoscopic retrograde cholangiopancreatography are associated with worse outcomes in patients with acute cholangitis. Clin Gastroenterol Hepatol. 2012 Oct;10(10):1157-61. doi: 10.1016/j.cgh.2012.03.029. Epub 2012 Apr 13.
PMID: 22507875
citation: Navaneethan U, Gutierrez NG, Jegadeesan R, Venkatesh PG, Butt M, Sanaka MR, Vargo JJ, Parsi MA. Delay in performing ERCP and adverse events increase the 30-day readmission risk in patients with acute cholangitis. Gastrointest Endosc. 2013 Jul;78(1):81-90. doi: 10.1016/j.gie.2013.02.003. Epub 2013 Mar 23.
PMID: 23528654
citation: Barkun AN, Barkun JS, Fried GM, Ghitulescu G, Steinmetz O, Pham C, Meakins JL, Goresky CA. Useful predictors of bile duct stones in patients undergoing laparoscopic cholecystectomy. McGill Gallstone Treatment Group. Ann Surg. 1994 Jul;220(1):32-9. doi: 10.1097/00000658-199407000-00006.
PMID: 7517657
responsible party type: Principal Investigator
investigator affiliation: University of Southern California
investigator full name: James Buxbaum
investigator title: Director of Endoscopy, Los Angeles County Hospital
mesh term: Gastrointestinal Neoplasms
mesh term: Digestive System Neoplasms
mesh term: Pancreatitis
mesh term: Gallbladder Diseases
sharing ipd: Undecided