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

18 Years
Open (Enrolling)
Choledocholithiasis, Common Bile Duct Neoplasms, Cholestasis

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Trial Information

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

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

This study is designed to test the efficiency of the device in relation to this assumption.

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)

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy of cholangioscopy in gallstone therapy and stricture diagnosis

Outcome Description:

complete lithotripsy in a single session rate of right positive malignoma diagnostics (sensitivity)

Outcome Time Frame:

Patients will be monitored during stay in hospital, average stay is 1 day

Safety Issue:


Principal Investigator

Thomas Rösch, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universitätsklinikum Hamburg-Eppendorf


Germany: Ethics Commission

Study ID:

Short Access Cholangioscope



Start Date:

February 2011

Completion Date:

December 2013

Related Keywords:

  • Choledocholithiasis
  • Common Bile Duct Neoplasms
  • Cholestasis
  • cholangiography
  • cholangioscopy
  • mother-baby
  • cholangioscope
  • Frimberger cholangioscope
  • short access cholangioscopy
  • ERCP
  • gallstone therapy
  • Bile Duct Neoplasms
  • Neoplasms
  • Gallstones
  • Cholelithiasis
  • Cholecystolithiasis
  • Cholestasis
  • Common Bile Duct Neoplasms
  • Choledocholithiasis
  • Constriction, Pathologic