Choledocholithiasis, Cholestasis, Common Bile Duct Neoplasms
Conditions
Keywords
cholangiography, cholangioscopy, mother-baby, cholangioscope, Frimberger cholangioscope, short access cholangioscopy, ERCP, gallstone therapy
Brief summary
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.
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.
Interventions
DEVICEcholangioscopy (Frimberger)
cholangioscopy with Frimberger duodenoscope system by the company of Karl Storz GmbH
Sponsors
KARL STORZ GmbH & Co. KG, Tuttlingen, Germany
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of cholangioscopy in gallstone therapy and stricture diagnosis | Patients will be monitored during stay in hospital, average stay is 1 day | 1. complete lithotripsy in a single session 2. rate of right positive malignoma diagnostics (sensitivity) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication rate | while examination and 24 hrs past examination | Number of complications during examination and during monitoring over 24 hours post procedure |
| Gallstone therapy | procedure, average procedure time 1 hour | Time of procedure and success of stone extraction in % |
| Stricture diagnostic | procedure, average procedure time is 1 hour | 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) |
Countries
Germany
Outcome results
None listed