Prospective Multicenter Evaluation of a New Short-access-cholangioscope for Biliary Duct Strictures and Gall Stones (SAC)
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.
Common Bile Duct Neoplasms
Device: cholangioscopy (Frimberger)
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Multicenter Evaluation of a New Short-access-cholangioscope for Biliary Duct Strictures and Gall Stones|
- Efficacy of cholangioscopy in gallstone therapy and stricture diagnosis [ Time Frame: Patients will be monitored during stay in hospital, average stay is 1 day ] [ Designated as safety issue: No ]
- complete lithotripsy in a single session
- rate of right positive malignoma diagnostics (sensitivity)
- Complication rate [ Time Frame: while examination and 24 hrs past examination ] [ Designated as safety issue: Yes ]Number of complications during examination and during monitoring over 24 hours post procedure
- Gallstone therapy [ Time Frame: procedure, average procedure time 1 hour ] [ Designated as safety issue: No ]Time of procedure and success of stone extraction in %
- Stricture diagnostic [ Time Frame: procedure, average procedure time is 1 hour ] [ Designated as safety issue: No ]
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)
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||June 2015|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Frimberger cholangioscope
Patients with need for cholangioscopy due to gallstones or histological evaluation of strictures
Device: cholangioscopy (Frimberger)
cholangioscopy with Frimberger duodenoscope system by the company of Karl Storz GmbH
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683240
|Charité Universitätsmedizin, Virchow Klinikum|
|Berlin, Germany, 13353|
|Asklepios Klinik Hamburg Altona|
|Hamburg, Germany, 22763|
|Asklepios Klinik Hamburg Barmbek|
|Hamburg, Germany, 22291|
|Hamburg, Germany, 22297|
|University Hospital Hamburg-Eppendorf|
|Hamburg, Germany, 20246|
|Principal Investigator:||Thomas Rösch, Prof. Dr.||Universitätsklinikum Hamburg-Eppendorf|