Prospective Multicenter Evaluation of a New Short-access-cholangioscope for Biliary Duct Strictures and Gall Stones
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 59
- Locations
- 5
- Primary Endpoint
- Efficacy of cholangioscopy in gallstone therapy and stricture diagnosis
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- 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)
Arms & Interventions
Frimberger cholangioscope
Patients with need for cholangioscopy due to gallstones or histological evaluation of strictures
Intervention: cholangioscopy (Frimberger) (Device)
Outcomes
Primary Outcomes
Efficacy of cholangioscopy in gallstone therapy and stricture diagnosis
Time Frame: 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 Outcomes
- Complication rate(while examination and 24 hrs past examination)
- Gallstone therapy(procedure, average procedure time 1 hour)
- Stricture diagnostic(procedure, average procedure time is 1 hour)