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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Universitätsklinikum Hamburg-Eppendorf
Sponsor:
Collaborator:
KARL STORZ GmbH & Co. KG, Tuttlingen, Germany
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01683240
First received: July 6, 2012
Last updated: April 14, 2014
Last verified: April 2014

July 6, 2012
April 14, 2014
February 2011
July 2014   (final data collection date for primary outcome measure)
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 ]
  1. complete lithotripsy in a single session
  2. rate of right positive malignoma diagnostics (sensitivity)
Same as current
Complete list of historical versions of study NCT01683240 on ClinicalTrials.gov Archive Site
  • 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)

Same as current
Not Provided
Not Provided
 
Prospective Multicenter Evaluation of a New Short-access-cholangioscope for Biliary Duct Strictures and Gall Stones
Prospective Multicenter Evaluation of a New Short-access-cholangioscope for Biliary Duct Strictures and Gall Stones

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Choledocholithiasis
  • Common Bile Duct Neoplasms
  • Cholestasis
Device: cholangioscopy (Frimberger)
cholangioscopy with Frimberger duodenoscope system by the company of Karl Storz GmbH
Experimental: Frimberger cholangioscope
Patients with need for cholangioscopy due to gallstones or histological evaluation of strictures
Intervention: Device: cholangioscopy (Frimberger)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
July 2014
July 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Thomas Rösch, Prof. Dr. +49 40 7410 ext 50098 t.roesch@uke.de
Contact: Ulrike W Denzer, PD DR. +49 40 7410 ext 55380 u.denzer@uke.de
Germany
 
NCT01683240
Short Access Cholangioscope, PV 3526
No
Universitätsklinikum Hamburg-Eppendorf
Universitätsklinikum Hamburg-Eppendorf
KARL STORZ GmbH & Co. KG, Tuttlingen, Germany
Principal Investigator: Thomas Rösch, Prof. Dr. Universitätsklinikum Hamburg-Eppendorf
Universitätsklinikum Hamburg-Eppendorf
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP