Prospective Multicenter Evaluation of a New Short-access-cholangioscope for Biliary Duct Strictures and Gall Stones

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Multicenter Evaluation of a New Short-access-cholangioscope for Biliary Duct Strictures and Gall Stones

Conditions
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Choledocholithiasis, Common Bile Duct Neoplasms, Cholestasis

Intervention / Treatment
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* Device: cholangioscopy (Frimberger)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Frimberger cholangioscope<br>Patients with need for cholangioscopy due to gallstones or histological evaluation of strictures | Device: cholangioscopy (Frimberger)<br>* cholangioscopy with Frimberger duodenoscope system by the company of Karl Storz GmbH<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of cholangioscopy in gallstone therapy and stricture diagnosis | complete lithotripsy in a single session rate of right positive malignoma diagnostics (sensitivity) | Patients will be monitored during stay in hospital, average stay is 1 day | 

Secondary Outcome Measures

| Outcome Measure | 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 % | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gallstone therapy, cholangiography, cholangioscopy, mother-baby, cholangioscope, Frimberger cholangioscope, short access cholangioscopy, ERCP