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

May 10, 2016 updated by: Universitätsklinikum Hamburg-Eppendorf
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Charité Universitätsmedizin, Virchow Klinikum
      • Hamburg, Germany, 20246
        • University Hospital Hamburg-Eppendorf
      • Hamburg, Germany, 22297
        • Israelitisches Krankenhaus
      • Hamburg, Germany, 22291
        • Asklepios Klinik Hamburg Barmbek
      • Hamburg, Germany, 22763
        • Asklepios Klinik Hamburg Altona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Patients will be monitored during stay in hospital, average stay is 1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rate
Time Frame: while examination and 24 hrs past examination
Number of complications during examination and during monitoring over 24 hours post procedure
while examination and 24 hrs past examination
Gallstone therapy
Time Frame: procedure, average procedure time 1 hour
Time of procedure and success of stone extraction in %
procedure, average procedure time 1 hour
Stricture diagnostic
Time Frame: 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)
procedure, average procedure time is 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Collaborators

KARL STORZ GmbH & Co. KG, Tuttlingen, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

July 6, 2012

First Submitted That Met QC Criteria

September 6, 2012

First Posted (Estimate)

September 11, 2012

Study Record Updates

Last Update Posted (Estimate)

May 11, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Short Access Cholangioscope
  • PV 3526 (Registry Identifier: Hamburg Ethical Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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