Prospective Multicenter Evaluation of a New Short-access-cholangioscope for Biliary Duct Strictures and Gall Stones (SAC)
|ClinicalTrials.gov Identifier: NCT01683240|
Recruitment Status : Completed
First Posted : September 11, 2012
Last Update Posted : May 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Choledocholithiasis Common Bile Duct Neoplasms Cholestasis||Device: cholangioscopy (Frimberger)||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Multicenter Evaluation of a New Short-access-cholangioscope for Biliary Duct Strictures and Gall Stones|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
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
- Efficacy of cholangioscopy in gallstone therapy and stricture diagnosis [ Time Frame: Patients will be monitored during stay in hospital, average stay is 1 day ]
- complete lithotripsy in a single session
- rate of right positive malignoma diagnostics (sensitivity)
- Complication rate [ Time Frame: while examination and 24 hrs past examination ]Number of complications during examination and during monitoring over 24 hours post procedure
- Gallstone therapy [ Time Frame: procedure, average procedure time 1 hour ]Time of procedure and success of stone extraction in %
- Stricture diagnostic [ Time Frame: procedure, average procedure time is 1 hour ]
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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01683240
|Charité Universitätsmedizin, Virchow Klinikum|
|Berlin, Germany, 13353|
|University Hospital Hamburg-Eppendorf|
|Hamburg, Germany, 20246|
|Asklepios Klinik Hamburg Barmbek|
|Hamburg, Germany, 22291|
|Hamburg, Germany, 22297|
|Asklepios Klinik Hamburg Altona|
|Hamburg, Germany, 22763|
|Principal Investigator:||Thomas Rösch, Prof. Dr.||Universitätsklinikum Hamburg-Eppendorf|