<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/NCT01683240</url>
  </required_header>
  <id_info>
    <org_study_id>Short Access Cholangioscope</org_study_id>
    <secondary_id>PV 3526</secondary_id>
    <nct_id>NCT01683240</nct_id>
  </id_info>
  <brief_title>Prospective Multicenter Evaluation of a New Short-access-cholangioscope for Biliary Duct Strictures and Gall Stones</brief_title>
  <acronym>SAC</acronym>
  <official_title>Prospective Multicenter Evaluation of a New Short-access-cholangioscope for Biliary Duct Strictures and Gall Stones</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>KARL STORZ GmbH &amp; Co. KG, Tuttlingen, Germany</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitätsklinikum Hamburg-Eppendorf</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Karl Storz GmbH (Gesellschaft mit beschränkter Haftung) company developed a cholangioscopic&#xD;
      device, which is designed to give a better flexibility to the cholangioscopy tip in order to&#xD;
      enable optimal diagnostic and therapeutic precondition. Other than the conventional&#xD;
      mother-baby technique, the insertion of the cholangioscope (baby part) is done by a port at&#xD;
      the side of a specially developed duodenoscope (mother part) which is prepositioned distally&#xD;
      to the control unit, near to the patient's mouth. Better manoeuverability of the device tip&#xD;
      will lead to both a better accuracy in taking biopsies as well as a better flexibility in&#xD;
      lithotripsy manoeuvres. This study is designed to test the efficiency of the device in&#xD;
      relation to this assumption.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cholangioscopy is a subsidiary treatment in endoscopic retrograde cholangiopancreaticography&#xD;
      (ERCP), used for special issues. In the context of ERCP, a long,thin shaped device is&#xD;
      introduced through the working channel of a duodenoscope and then through the papilla into&#xD;
      the biliary duct.&#xD;
&#xD;
      Inspection of the biliary duct can be used for tumor biopsies as well as for gall stone&#xD;
      lithotripsy by laser or electrohydraulic technique.&#xD;
&#xD;
      Manoeuverability of cholangioscopes is limited by the length of the scope, even more, since&#xD;
      most of the device body is stuck in the working channel.&#xD;
&#xD;
      The newly designed cholangioscope by the company of Karl Storz GmbH is introduced through a&#xD;
      shortened working channel. Introduction of the cholangioscope is done by an innovative side&#xD;
      port for the cholangioscope at 70 cm from the insertion tube's distal end. This leads to a&#xD;
      better flexibility of the device tip. Better manoeuverability of the device tip will lead to&#xD;
      both a better accuracy in taking biopsies as well as a better flexibility in lithotripsy&#xD;
      manoeuvres.&#xD;
&#xD;
      This study is designed to test the efficiency of the device in relation to this assumption.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of cholangioscopy in gallstone therapy and stricture diagnosis</measure>
    <time_frame>Patients will be monitored during stay in hospital, average stay is 1 day</time_frame>
    <description>complete lithotripsy in a single session&#xD;
rate of right positive malignoma diagnostics (sensitivity)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complication rate</measure>
    <time_frame>while examination and 24 hrs past examination</time_frame>
    <description>Number of complications during examination and during monitoring over 24 hours post procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gallstone therapy</measure>
    <time_frame>procedure, average procedure time 1 hour</time_frame>
    <description>Time of procedure and success of stone extraction in %</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stricture diagnostic</measure>
    <time_frame>procedure, average procedure time is 1 hour</time_frame>
    <description>Number of biopsies taken. Evaluation of quality of biopsies by pathologists (pathological department of University Hospital Hamburg Eppendorf).&#xD;
Minimum number of bioptic manoeuvres: 3 Comparison with brush cytology (3 brush manoeuvres with 12 smear preparations) by reference cytologist (Dr. Topalidis, Hannover)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Choledocholithiasis</condition>
  <condition>Common Bile Duct Neoplasms</condition>
  <condition>Cholestasis</condition>
  <arm_group>
    <arm_group_label>Frimberger cholangioscope</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with need for cholangioscopy due to gallstones or histological evaluation of strictures</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>cholangioscopy (Frimberger)</intervention_name>
    <description>cholangioscopy with Frimberger duodenoscope system by the company of Karl Storz GmbH</description>
    <arm_group_label>Frimberger cholangioscope</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Choledocholithiasis, not treatable through conventional ERCP with sphincterotomy.&#xD;
&#xD;
          -  Stricture of the biliary duct in need of histopathological investigation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Aggravated or impossible access to papilla&#xD;
&#xD;
          -  Inappropriate biliary anatomy, e.g. multiple strictures or diameter of duct &lt;&#xD;
             cholangioscope impairing intubation&#xD;
&#xD;
          -  Primary sclerosing cholangitis&#xD;
&#xD;
          -  Coagulopathy (quick &lt; 50%, thrombocytes &lt; 50/nl)and anticoagulant medication&#xD;
&#xD;
          -  Bad patient's condition (ASA IV)&#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>Thomas Rösch, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitätsklinikum Hamburg-Eppendorf</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Charité Universitätsmedizin, Virchow Klinikum</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Hamburg-Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinik Hamburg Barmbek</name>
      <address>
        <city>Hamburg</city>
        <zip>22291</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Israelitisches Krankenhaus</name>
      <address>
        <city>Hamburg</city>
        <zip>22297</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinik Hamburg Altona</name>
      <address>
        <city>Hamburg</city>
        <zip>22763</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Pomerantz BJ. Biliary tract interventions. Tech Vasc Interv Radiol. 2009 Jun;12(2):162-70. doi: 10.1053/j.tvir.2009.08.009.</citation>
    <PMID>19853234</PMID>
  </reference>
  <reference>
    <citation>Tsuyuguchi T, Fukuda Y, Saisho H. Peroral cholangioscopy for the diagnosis and treatment of biliary diseases. J Hepatobiliary Pancreat Surg. 2006;13(2):94-9. doi: 10.1007/s00534-005-1064-2.</citation>
    <PMID>16547668</PMID>
  </reference>
  <reference>
    <citation>Ross AS, Kozarek RA. Cholangioscopy: where are we now? Curr Opin Gastroenterol. 2009 May;25(3):245-51. doi: 10.1097/MOG.0b013e328329236c.</citation>
    <PMID>19381085</PMID>
  </reference>
  <reference>
    <citation>Darcy M, Picus D. Cholangioscopy. Tech Vasc Interv Radiol. 2008 Jun;11(2):133-42. doi: 10.1053/j.tvir.2008.07.007.</citation>
    <PMID>18922458</PMID>
  </reference>
  <reference>
    <citation>Small AJ, Baron TH. Novel endoscopic approaches for assessing biliary tract diseases. Curr Opin Gastroenterol. 2008 May;24(3):357-62. doi: 10.1097/MOG.0b013e3282fad830.</citation>
    <PMID>18408465</PMID>
  </reference>
  <reference>
    <citation>Fukuda Y, Tsuyuguchi T, Sakai Y, Tsuchiya S, Saisyo H. Diagnostic utility of peroral cholangioscopy for various bile-duct lesions. Gastrointest Endosc. 2005 Sep;62(3):374-82. doi: 10.1016/j.gie.2005.04.032.</citation>
    <PMID>16111955</PMID>
  </reference>
  <reference>
    <citation>Kim HJ, Kim MH, Lee SK, Yoo KS, Seo DW, Min YI. Tumor vessel: a valuable cholangioscopic clue of malignant biliary stricture. Gastrointest Endosc. 2000 Nov;52(5):635-8. doi: 10.1067/mge.2000.108969.</citation>
    <PMID>11060188</PMID>
  </reference>
  <reference>
    <citation>Nimura Y, Kamiya J, Hayakawa N, Shionoya S. Cholangioscopic differentiation of biliary strictures and polyps. Endoscopy. 1989 Dec;21 Suppl 1:351-6. doi: 10.1055/s-2007-1012989.</citation>
    <PMID>2606085</PMID>
  </reference>
  <reference>
    <citation>Seo DW, Lee SK, Yoo KS, Kang GH, Kim MH, Suh DJ, Min YI. Cholangioscopic findings in bile duct tumors. Gastrointest Endosc. 2000 Nov;52(5):630-4. doi: 10.1067/mge.2000.108667.</citation>
    <PMID>11060187</PMID>
  </reference>
  <reference>
    <citation>Tamada K, Ueno N, Tomiyama T, Oohashi A, Wada S, Nishizono T, Tano S, Aizawa T, Ido K, Kimura K. Characterization of biliary strictures using intraductal ultrasonography: comparison with percutaneous cholangioscopic biopsy. Gastrointest Endosc. 1998 May;47(5):341-9. doi: 10.1016/s0016-5107(98)70216-0.</citation>
    <PMID>9609424</PMID>
  </reference>
  <reference>
    <citation>Itoi T, Sofuni A, Itokawa F, Tsuchiya T, Kurihara T, Ishii K, Tsuji S, Moriyasu F, Gotoda T. Peroral cholangioscopic diagnosis of biliary-tract diseases by using narrow-band imaging (with videos). Gastrointest Endosc. 2007 Oct;66(4):730-6. doi: 10.1016/j.gie.2007.02.056.</citation>
    <PMID>17905015</PMID>
  </reference>
  <reference>
    <citation>Hoffman A, Kiesslich R, Bittinger F, Galle PR, Neurath MF. Methylene blue-aided cholangioscopy in patients with biliary strictures: feasibility and outcome analysis. Endoscopy. 2008 Jul;40(7):563-71. doi: 10.1055/s-2007-995688. Epub 2008 Apr 11.</citation>
    <PMID>18404601</PMID>
  </reference>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>July 6, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>May 10, 2016</last_update_submitted>
  <last_update_submitted_qc>May 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 11, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cholangiography</keyword>
  <keyword>cholangioscopy</keyword>
  <keyword>mother-baby</keyword>
  <keyword>cholangioscope</keyword>
  <keyword>Frimberger cholangioscope</keyword>
  <keyword>short access cholangioscopy</keyword>
  <keyword>ERCP</keyword>
  <keyword>gallstone therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bile Duct Neoplasms</mesh_term>
    <mesh_term>Common Bile Duct Neoplasms</mesh_term>
    <mesh_term>Cholestasis</mesh_term>
    <mesh_term>Choledocholithiasis</mesh_term>
    <mesh_term>Gallstones</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/NCT01683240
org study id: Short Access Cholangioscope
secondary id: PV 3526
nct id: NCT01683240
lead sponsor: 
collaborator: 
has dmc: No
Karl Storz GmbH (Gesellschaft mit beschränkter Haftung) company developed a cholangioscopic
      device, which is designed to give a better flexibility to the cholangioscopy tip in order to
      enable optimal diagnostic and therapeutic precondition. Other than the conventional
      mother-baby technique, the insertion of the cholangioscope (baby part) is done by a port at
      the side of a specially developed duodenoscope (mother part) which is prepositioned distally
      to the control unit, near to the patient's mouth. Better manoeuverability of the device tip
      will lead to both a better accuracy in taking biopsies as well as a better flexibility in
      lithotripsy manoeuvres. This study is designed to test the efficiency of the device in
      relation to this assumption.
Cholangioscopy is a subsidiary treatment in endoscopic retrograde cholangiopancreaticography
      (ERCP), used for special issues. In the context of ERCP, a long,thin shaped device is
      introduced through the working channel of a duodenoscope and then through the papilla into
      the biliary duct.

      Inspection of the biliary duct can be used for tumor biopsies as well as for gall stone
      lithotripsy by laser or electrohydraulic technique.

      Manoeuverability of cholangioscopes is limited by the length of the scope, even more, since
      most of the device body is stuck in the working channel.

      The newly designed cholangioscope by the company of Karl Storz GmbH is introduced through a
      shortened working channel. Introduction of the cholangioscope is done by an innovative side
      port for the cholangioscope at 70 cm from the insertion tube's distal end. This leads to a
      better flexibility of the device tip. Better manoeuverability of the device tip will lead to
      both a better accuracy in taking biopsies as well as a better flexibility in lithotripsy
      manoeuvres.

      This study is designed to test the efficiency of the device in relation to this assumption.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Efficacy of cholangioscopy in gallstone therapy and stricture diagnosis
time frame: Patients will be monitored during stay in hospital, average stay is 1 day
description: complete lithotripsy in a single session
rate of right positive malignoma diagnostics (sensitivity)
measure: Complication rate
time frame: while examination and 24 hrs past examination
description: Number of complications during examination and during monitoring over 24 hours post procedure
measure: Gallstone therapy
time frame: procedure, average procedure time 1 hour
description: Time of procedure and success of stone extraction in %
measure: Stricture diagnostic
time frame: procedure, average procedure time is 1 hour
description: Number of biopsies taken. Evaluation of quality of biopsies by pathologists (pathological department of University Hospital Hamburg Eppendorf).
Minimum number of bioptic manoeuvres: 3 Comparison with brush cytology (3 brush manoeuvres with 12 smear preparations) by reference cytologist (Dr. Topalidis, Hannover)
arm group label: Frimberger cholangioscope
arm group type: Experimental
description: Patients with need for cholangioscopy due to gallstones or histological evaluation of strictures
intervention type: Device
intervention name: cholangioscopy (Frimberger)
description: cholangioscopy with Frimberger duodenoscope system by the company of Karl Storz GmbH
arm group label: Frimberger cholangioscope
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas Rösch, Prof. Dr.
role: Principal Investigator
affiliation: Universitätsklinikum Hamburg-Eppendorf
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
citation: Pomerantz BJ. Biliary tract interventions. Tech Vasc Interv Radiol. 2009 Jun;12(2):162-70. doi: 10.1053/j.tvir.2009.08.009.
PMID: 19853234
citation: Tsuyuguchi T, Fukuda Y, Saisho H. Peroral cholangioscopy for the diagnosis and treatment of biliary diseases. J Hepatobiliary Pancreat Surg. 2006;13(2):94-9. doi: 10.1007/s00534-005-1064-2.
PMID: 16547668
citation: Ross AS, Kozarek RA. Cholangioscopy: where are we now? Curr Opin Gastroenterol. 2009 May;25(3):245-51. doi: 10.1097/MOG.0b013e328329236c.
PMID: 19381085
citation: Darcy M, Picus D. Cholangioscopy. Tech Vasc Interv Radiol. 2008 Jun;11(2):133-42. doi: 10.1053/j.tvir.2008.07.007.
PMID: 18922458
citation: Small AJ, Baron TH. Novel endoscopic approaches for assessing biliary tract diseases. Curr Opin Gastroenterol. 2008 May;24(3):357-62. doi: 10.1097/MOG.0b013e3282fad830.
PMID: 18408465
citation: Fukuda Y, Tsuyuguchi T, Sakai Y, Tsuchiya S, Saisyo H. Diagnostic utility of peroral cholangioscopy for various bile-duct lesions. Gastrointest Endosc. 2005 Sep;62(3):374-82. doi: 10.1016/j.gie.2005.04.032.
PMID: 16111955
citation: Kim HJ, Kim MH, Lee SK, Yoo KS, Seo DW, Min YI. Tumor vessel: a valuable cholangioscopic clue of malignant biliary stricture. Gastrointest Endosc. 2000 Nov;52(5):635-8. doi: 10.1067/mge.2000.108969.
PMID: 11060188
citation: Nimura Y, Kamiya J, Hayakawa N, Shionoya S. Cholangioscopic differentiation of biliary strictures and polyps. Endoscopy. 1989 Dec;21 Suppl 1:351-6. doi: 10.1055/s-2007-1012989.
PMID: 2606085
citation: Seo DW, Lee SK, Yoo KS, Kang GH, Kim MH, Suh DJ, Min YI. Cholangioscopic findings in bile duct tumors. Gastrointest Endosc. 2000 Nov;52(5):630-4. doi: 10.1067/mge.2000.108667.
PMID: 11060187
citation: Tamada K, Ueno N, Tomiyama T, Oohashi A, Wada S, Nishizono T, Tano S, Aizawa T, Ido K, Kimura K. Characterization of biliary strictures using intraductal ultrasonography: comparison with percutaneous cholangioscopic biopsy. Gastrointest Endosc. 1998 May;47(5):341-9. doi: 10.1016/s0016-5107(98)70216-0.
PMID: 9609424
citation: Itoi T, Sofuni A, Itokawa F, Tsuchiya T, Kurihara T, Ishii K, Tsuji S, Moriyasu F, Gotoda T. Peroral cholangioscopic diagnosis of biliary-tract diseases by using narrow-band imaging (with videos). Gastrointest Endosc. 2007 Oct;66(4):730-6. doi: 10.1016/j.gie.2007.02.056.
PMID: 17905015
citation: Hoffman A, Kiesslich R, Bittinger F, Galle PR, Neurath MF. Methylene blue-aided cholangioscopy in patients with biliary strictures: feasibility and outcome analysis. Endoscopy. 2008 Jul;40(7):563-71. doi: 10.1055/s-2007-995688. Epub 2008 Apr 11.
PMID: 18404601
responsible party type: Sponsor
mesh term: Bile Duct Neoplasms
mesh term: Common Bile Duct Neoplasms
mesh term: Cholestasis
mesh term: Choledocholithiasis
mesh term: Gallstones
sharing ipd: Undecided