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

Not Applicable

Completed

• Conditions: Cholestasis; Choledocholithiasis; Common Bile Duct Neoplasms
• Interventions: Device: cholangioscopy (Frimberger)

• Registration Number: NCT01683240
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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 Timeline

• Study Start: 2011-02
• Study First Submitted: 2012-07-06
• Study First Submitted QC: 2012-09-06
• Study First Posted: 2012-09-11
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Frimberger cholangioscope	cholangioscopy (Frimberger)	Patients with need for cholangioscopy due to gallstones or histological evaluation of strictures

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (5)

Charité Universitätsmedizin, Virchow Klinikum; 🇩🇪 Berlin, Germany

University Hospital Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Israelitisches Krankenhaus; 🇩🇪 Hamburg, Germany

Asklepios Klinik Hamburg Barmbek; 🇩🇪 Hamburg, Germany

Asklepios Klinik Hamburg Altona; 🇩🇪 Hamburg, Germany