Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| PV 3526 | Registry Identifier | Hamburg Ethical Committee |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| KARL STORZ GmbH & Co. KG, Tuttlingen, Germany | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Frimberger cholangioscope | Experimental | Patients with need for cholangioscopy due to gallstones or histological evaluation of strictures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cholangioscopy (Frimberger) | Device | cholangioscopy with Frimberger duodenoscope system by the company of Karl Storz GmbH |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of cholangioscopy in gallstone therapy and stricture diagnosis |
| Patients will be monitored during stay in hospital, average stay is 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Complication rate | Number of complications during examination and during monitoring over 24 hours post procedure | while examination and 24 hrs past examination |
| Gallstone therapy | Time of procedure and success of stone extraction in % |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas Rösch, Prof. Dr. | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Universitätsmedizin, Virchow Klinikum | Berlin | 13353 | Germany | |||
| University Hospital Hamburg-Eppendorf |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19853234 | Background | Pomerantz BJ. Biliary tract interventions. Tech Vasc Interv Radiol. 2009 Jun;12(2):162-70. doi: 10.1053/j.tvir.2009.08.009. | |
| 16547668 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| procedure, average procedure time 1 hour |
| Stricture diagnostic | 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) | procedure, average procedure time is 1 hour |
| Hamburg |
| 20246 |
| Germany |
| Asklepios Klinik Hamburg Barmbek | Hamburg | 22291 | Germany |
| Israelitisches Krankenhaus | Hamburg | 22297 | Germany |
| Asklepios Klinik Hamburg Altona | Hamburg | 22763 | Germany |
| 19381085 | Background | Ross AS, Kozarek RA. Cholangioscopy: where are we now? Curr Opin Gastroenterol. 2009 May;25(3):245-51. doi: 10.1097/MOG.0b013e328329236c. |
| 18922458 | Background | Darcy M, Picus D. Cholangioscopy. Tech Vasc Interv Radiol. 2008 Jun;11(2):133-42. doi: 10.1053/j.tvir.2008.07.007. |
| 18408465 | Background | 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. |
| 16111955 | Background | 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. |
| 11060188 | Background | 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. |
| 2606085 | Background | 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. |
| 11060187 | Background | 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. |
| 9609424 | Background | 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. |
| 17905015 | Background | 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. |
| 18404601 | Background | 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. |
| ID | Term |
|---|---|
| D042883 | Choledocholithiasis |
| D003138 | Common Bile Duct Neoplasms |
| D002779 | Cholestasis |
| ID | Term |
|---|---|
| D003137 | Common Bile Duct Diseases |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D002769 | Cholelithiasis |
| D001650 | Bile Duct Neoplasms |
| D001661 | Biliary Tract Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided