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

Sponsor

Universitätsklinikum Hamburg-Eppendorf (Other)

Overall Status

Completed

CT.gov ID

NCT01683240

Collaborator

KARL STORZ GmbH & Co. KG, Tuttlingen, Germany (Other)

Enrollment

Locations

Arm

Duration (Months)

11.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Choledocholithiasis Common Bile Duct Neoplasms Cholestasis	Device: cholangioscopy (Frimberger)	N/A

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

Actual Enrollment :

59 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

Feb 1, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Frimberger cholangioscope

Patients with need for cholangioscopy due to gallstones or histological evaluation of strictures

Device: cholangioscopy (Frimberger)

cholangioscopy with Frimberger duodenoscope system by the company of Karl Storz GmbH

Outcome Measures

Primary Outcome Measures

Efficacy of cholangioscopy in gallstone therapy and stricture diagnosis [Patients will be monitored during stay in hospital, average stay is 1 day]
complete lithotripsy in a single session rate of right positive malignoma diagnostics (sensitivity)

Secondary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Charité Universitätsmedizin, Virchow Klinikum	Berlin	Germany	13353
2	University Hospital Hamburg-Eppendorf	Hamburg	Germany	20246
3	Asklepios Klinik Hamburg Barmbek	Hamburg	Germany	22291
4	Israelitisches Krankenhaus	Hamburg	Germany	22297
5	Asklepios Klinik Hamburg Altona	Hamburg	Germany	22763