NCT01683240|Completed
Prospective Multicenter Evaluation of a New Short-access-cholangioscope for Biliary Duct Strictures and Gall Stones
SAC
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SAC
Sponsor study identifier
Secondary identifiers
REGISTRY · Hamburg Ethical Committee
interventional
59
1 country
5
Study Start
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2016
Actual (reported)Study Completion
February 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
July 6, 2012
Actual (reported)September 11, 2012
Actual (reported)February 2016
Actual (reported)February 2016
Actual (reported)Efficacy of cholangioscopy in gallstone therapy and stricture diagnosis
1. complete lithotripsy in a single session 2. rate of right positive malignoma diagnostics (sensitivity)
Patients will be monitored during stay in hospital, average stay is 1 day
Complication rate
while examination and 24 hrs past examination
Gallstone therapy
procedure, average procedure time 1 hour
Patients with need for cholangioscopy due to gallstones or histological evaluation of strictures
cholangioscopy with Frimberger duodenoscope system by the company of Karl Storz GmbH
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Charité Universitätsmedizin, Virchow Klinikum
Berlin, 13353, Germany
University Hospital Hamburg-Eppendorf
Hamburg, 20246, Germany
Asklepios Klinik Hamburg Barmbek
Hamburg, 22291, Germany
Israelitisches Krankenhaus
Hamburg, 22297, Germany
Asklepios Klinik Hamburg Altona
Hamburg, 22763, Germany
Pomerantz BJ. Biliary tract interventions. Tech Vasc Interv Radiol. 2009 Jun;12(2):162-70. doi: 10.1053/j.tvir.2009.08.009.
Tsuyuguchi T, Fukuda Y, Saisho H. Peroral cholangioscopy for the diagnosis and treatment of biliary diseases. J Hepatobiliary Pancreat Surg. 2006;13(2):94-9. doi: 10.1007/s00534-005-1064-2.
Ross AS, Kozarek RA. Cholangioscopy: where are we now? Curr Opin Gastroenterol. 2009 May;25(3):245-51. doi: 10.1097/MOG.0b013e328329236c.
Thomas Rösch, Prof. Dr.
Universitätsklinikum Hamburg-Eppendorf
59 participants (actual enrollment reported by the registry).
First Submitted
July 6, 2012
First Posted
September 11, 2012
Study Start
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
Stricture diagnostic
procedure, average procedure time is 1 hour
Contact the study team to confirm eligibility.
Darcy M, Picus D. Cholangioscopy. Tech Vasc Interv Radiol. 2008 Jun;11(2):133-42. doi: 10.1053/j.tvir.2008.07.007.
Small AJ, Baron TH. Novel endoscopic approaches for assessing biliary tract diseases. Curr Opin Gastroenterol. 2008 May;24(3):357-62. doi: 10.1097/MOG.0b013e3282fad830.
Fukuda Y, Tsuyuguchi T, Sakai Y, Tsuchiya S, Saisyo H. Diagnostic utility of peroral cholangioscopy for various bile-duct lesions. Gastrointest Endosc. 2005 Sep;62(3):374-82. doi: 10.1016/j.gie.2005.04.032.
Kim HJ, Kim MH, Lee SK, Yoo KS, Seo DW, Min YI. Tumor vessel: a valuable cholangioscopic clue of malignant biliary stricture. Gastrointest Endosc. 2000 Nov;52(5):635-8. doi: 10.1067/mge.2000.108969.
Nimura Y, Kamiya J, Hayakawa N, Shionoya S. Cholangioscopic differentiation of biliary strictures and polyps. Endoscopy. 1989 Dec;21 Suppl 1:351-6. doi: 10.1055/s-2007-1012989.
Seo DW, Lee SK, Yoo KS, Kang GH, Kim MH, Suh DJ, Min YI. Cholangioscopic findings in bile duct tumors. Gastrointest Endosc. 2000 Nov;52(5):630-4. doi: 10.1067/mge.2000.108667.
Tamada K, Ueno N, Tomiyama T, Oohashi A, Wada S, Nishizono T, Tano S, Aizawa T, Ido K, Kimura K. Characterization of biliary strictures using intraductal ultrasonography: comparison with percutaneous cholangioscopic biopsy. Gastrointest Endosc. 1998 May;47(5):341-9. doi: 10.1016/s0016-5107(98)70216-0.
Itoi T, Sofuni A, Itokawa F, Tsuchiya T, Kurihara T, Ishii K, Tsuji S, Moriyasu F, Gotoda T. Peroral cholangioscopic diagnosis of biliary-tract diseases by using narrow-band imaging (with videos). Gastrointest Endosc. 2007 Oct;66(4):730-6. doi: 10.1016/j.gie.2007.02.056.
Hoffman A, Kiesslich R, Bittinger F, Galle PR, Neurath MF. Methylene blue-aided cholangioscopy in patients with biliary strictures: feasibility and outcome analysis. Endoscopy. 2008 Jul;40(7):563-71. doi: 10.1055/s-2007-995688. Epub 2008 Apr 11.
Primary Completion
February 2016
Actual (reported)Study Completion
February 2016
Actual (reported)Last Updated
May 11, 2016
Record last verified: 2016-05
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