Clinical trial NCT01683240: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Choledocholithiasis
Common Bile Duct Neoplasms
Cholestasis
Keywords: cholangiography
cholangioscopy
mother-baby
cholangioscope
Frimberger cholangioscope
short access cholangioscopy
ERCP
gallstone therapy
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: KARL STORZ GmbH & Co. KG, Tuttlingen, Germany
First posted: 2012-09-11
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Efficacy of cholangioscopy in gallstone therapy and stricture diagnosis
timeFrame: Patients will be monitored during stay in hospital, average stay is 1 day
Secondary outcomes:
measure: Complication rate
timeFrame: while examination and 24 hrs past examination
measure: Gallstone therapy
timeFrame: procedure, average procedure time 1 hour
measure: Stricture diagnostic
timeFrame: procedure, average procedure time is 1 hour
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin, Virchow Klinikum
city: Hamburg
country: Germany
facility: University Hospital Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Asklepios Klinik Hamburg Barmbek
city: Hamburg
country: Germany
facility: Israelitisches Krankenhaus
city: Hamburg
country: Germany
facility: Asklepios Klinik Hamburg Altona
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Thomas Rösch, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
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