Prospective Multicenter Evaluation of a New Short-access-cholangioscope for Biliary Duct Strictures and Gall Stones

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Brief Title

Prospective Multicenter Evaluation of a New Short-access-cholangioscope for Biliary Duct Strictures and Gall Stones

Official Title

Prospective Multicenter Evaluation of a New Short-access-cholangioscope for Biliary Duct Strictures and Gall Stones

Brief Summary

      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.
    

Detailed Description

      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.
    


Study Type

Interventional


Primary Outcome

Efficacy of cholangioscopy in gallstone therapy and stricture diagnosis

Secondary Outcome

 Complication rate

Condition

Choledocholithiasis

Intervention

cholangioscopy (Frimberger)

Study Arms / Comparison Groups

 Frimberger cholangioscope
Description:  Patients with need for cholangioscopy due to gallstones or histological evaluation of strictures

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

59

Start Date

February 2011

Completion Date

February 2016

Primary Completion Date

February 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Choledocholithiasis, not treatable through conventional ERCP with sphincterotomy.

          -  Stricture of the biliary duct in need of histopathological investigation

        Exclusion Criteria:

          -  Aggravated or impossible access to papilla

          -  Inappropriate biliary anatomy, e.g. multiple strictures or diameter of duct <
             cholangioscope impairing intubation

          -  Primary sclerosing cholangitis

          -  Coagulopathy (quick < 50%, thrombocytes < 50/nl)and anticoagulant medication

          -  Bad patient's condition (ASA IV)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Thomas Rösch, Prof. Dr., , 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT01683240

Organization ID

Short Access Cholangioscope

Secondary IDs

PV 3526

Responsible Party

Sponsor

Study Sponsor

Universitätsklinikum Hamburg-Eppendorf

Collaborators

 KARL STORZ GmbH & Co. KG, Tuttlingen, Germany

Study Sponsor

Thomas Rösch, Prof. Dr., Principal Investigator, Universitätsklinikum Hamburg-Eppendorf


Verification Date

May 2016