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
  Purpose

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.


Condition Intervention
Choledocholithiasis
Common Bile Duct Neoplasms
Cholestasis
Device: cholangioscopy (Frimberger)

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)



Estimated Enrollment: 100
Study Start Date: February 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683240

Contacts
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

Locations
Germany
Charité Universitätsmedizin, Virchow Klinikum Recruiting
Berlin, Germany, 13353
Contact: W. Veltzke-Schlieker, Dr.         
Contact: A. Adler, Dr.         
Principal Investigator: W. Veltzke-Schlieker, Dr.         
Sub-Investigator: A. Adler, Dr.         
University Hospital Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
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   
Principal Investigator: Thomas Rösch, Prof. Dr.         
Sub-Investigator: Ulrike W Denzer, PD Dr.         
Sub-Investigator: Guido Schachschal, Dr         
Asklepios Klinik Hamburg Altona Not yet recruiting
Hamburg, Germany, 22763
Contact: Friedrich Hagenmüller, Prof. Dr.         
Principal Investigator: Friedrich Hagenmüller, Prof. Dr.         
Asklepios Klinik Hamburg Barmbek Not yet recruiting
Hamburg, Germany, 22291
Contact: Siegbert Faiss, PD Dr.         
Principal Investigator: Siegbert Faiss, PD Dr.         
Israelitisches Krankenhaus Not yet recruiting
Hamburg, Germany, 22297
Contact: Ulrich Rosien, Dr.         
Principal Investigator: Ulrich Rosien, Dr.         
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
KARL STORZ GmbH & Co. KG, Tuttlingen, Germany
Investigators
Principal Investigator: Thomas Rösch, Prof. Dr. Universitätsklinikum Hamburg-Eppendorf
  More Information

Publications:

Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01683240     History of Changes
Other Study ID Numbers: Short Access Cholangioscope, PV 3526
Study First Received: July 6, 2012
Last Updated: April 14, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
cholangiography
cholangioscopy
mother-baby
cholangioscope
Frimberger cholangioscope
short access cholangioscopy
ERCP
gallstone therapy

Additional relevant MeSH terms:
Bile Duct Neoplasms
Neoplasms
Gallstones
Cholelithiasis
Cholecystolithiasis
Cholestasis
Common Bile Duct Neoplasms
Choledocholithiasis
Constriction, Pathologic
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Common Bile Duct Diseases

ClinicalTrials.gov processed this record on August 19, 2014