Clinical trial · Interventional
Prospective Multicenter Evaluation of a New Short-access-cholangioscope for Biliary Duct Strictures and Gall Stones
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Choledocholithiasis | — | UNRESOLVED | — |
| Cholestasis | — | UNRESOLVED | — |
| Common Bile Duct Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cholangioscopy (Frimberger) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Frimberger cholangioscope
- description
- Patients with need for cholangioscopy due to gallstones or histological evaluation of strictures
- interventionNames
- Device: cholangioscopy (Frimberger)
Primary outcomes (1)
- measure
- Efficacy of cholangioscopy in gallstone therapy and stricture diagnosis
- timeFrame
- Patients will be monitored during stay in hospital, average stay is 1 day
- description
- 1. complete lithotripsy in a single session 2. rate of right positive malignoma diagnostics (sensitivity)
Secondary outcomes (3)
- measure
- Complication rate
- timeFrame
- while examination and 24 hrs past examination
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (12)
- BACKGROUNDPomerantz BJ. Biliary tract interventions. Tech Vasc Interv Radiol. 2009 Jun;12(2):162-70. doi: 10.1053/j.tvir.2009.08.009. PMID 19853234
- BACKGROUNDTsuyuguchi 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. PMID 16547668
- BACKGROUNDRoss AS, Kozarek RA. Cholangioscopy: where are we now? Curr Opin Gastroenterol. 2009 May;25(3):245-51. doi: 10.1097/MOG.0b013e328329236c. PMID 19381085
- BACKGROUNDDarcy M, Picus D. Cholangioscopy. Tech Vasc Interv Radiol. 2008 Jun;11(2):133-42. doi: 10.1053/j.tvir.2008.07.007. PMID 18922458
- BACKGROUNDSmall 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. PMID 18408465
- BACKGROUNDFukuda 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. PMID 16111955
- BACKGROUNDKim 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. PMID 11060188
- BACKGROUNDNimura 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. PMID 2606085
- 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.