Prospective Multicenter Evaluation of a New Short-access-cholangioscope for Biliary Duct Strictures and Gall Stones (SAC)
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Purpose
Karl Storz GmbH 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 |
- 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)
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (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 |
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| 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 | |
| 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. | |
| 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: | September 6, 2012 |
| 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 June 18, 2013