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CholedocholithiasisSACNCT01683240

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

A study testing cholangioscopy (Frimberger) in people with Choledocholithiasis and Common Bile Duct Neoplasms, run by Universitätsklinikum Hamburg-Eppendorf at 5 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
cholangioscopy (Frimberger)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
5 sitesGermany
Study dates
Feb 2011to Feb 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Choledocholithiasis, not treatable through conventional ERCP with sphincterotomy.
  • Stricture of the biliary duct in need of histopathological investigation

Who cannot join

  • 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)

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Germany5 sites

  • Charité Universitätsmedizin, Virchow Klinikum

    Berlin, 13353

  • University Hospital Hamburg-Eppendorf

    Hamburg, 20246

  • Asklepios Klinik Hamburg Barmbek

    Hamburg, 22291

  • Israelitisches Krankenhaus

    Hamburg, 22297

  • Asklepios Klinik Hamburg Altona

    Hamburg, 22763

Other trials in Germany

About this study

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.

Read the 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.

Being tested
cholangioscopy (Frimberger)
Keywords
cholangiography, cholangioscopy, mother-baby, cholangioscope, Frimberger cholangioscope, short access cholangioscopy, ERCP, gallstone therapy
Medical subject headings
Choledocholithiasis, Common Bile Duct Neoplasms, Cholestasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cholangioscopy (Frimberger)Device

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

Study groups in NCT01683240
Study groupRoleWhat they receive
Frimberger cholangioscopeExperimentalPatients with need for cholangioscopy due to gallstones or histological evaluation of strictures
Receives: Device: cholangioscopy (Frimberger)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of cholangioscopy in gallstone therapy and stricture diagnosis

    1. complete lithotripsy in a single session
    2. rate of right positive malignoma diagnostics (sensitivity)

    Measured: Patients will be monitored during stay in hospital, average stay is 1 day

Secondary outcomes (3)

  1. Complication rate

    Number of complications during examination and during monitoring over 24 hours post procedure

    Measured: while examination and 24 hrs past examination

  2. Gallstone therapy

    Time of procedure and success of stone extraction in %

    Measured: procedure, average procedure time 1 hour

  3. 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)

    Measured: procedure, average procedure time is 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2012 (estimated)
  2. Study startFeb 2011
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01683240
Sponsor's protocol ID
Short Access Cholangioscope
Other IDs
PV 3526
Acronym
SAC
Status last verified
May 2016
First submitted
6 Jul 2012
Last updated
11 May 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Pomerantz BJ. Biliary tract interventions. Tech Vasc Interv Radiol. 2009 Jun;12(2):162-70. doi: 10.1053/j.tvir.2009.08.009.

    PubMed 19853234

  • Tsuyuguchi T, Fukuda Y, Saisho H. Peroral cholangioscopy for the diagnosis and treatment of biliary diseases. J Hepatobiliary Pancreat Surg. 2006;13(2):94-9. doi: 10.1007/s00534-005-1064-2.

    PubMed 16547668

  • Ross AS, Kozarek RA. Cholangioscopy: where are we now? Curr Opin Gastroenterol. 2009 May;25(3):245-51. doi: 10.1097/MOG.0b013e328329236c.

    PubMed 19381085

  • Darcy M, Picus D. Cholangioscopy. Tech Vasc Interv Radiol. 2008 Jun;11(2):133-42. doi: 10.1053/j.tvir.2008.07.007.

    PubMed 18922458

  • Small AJ, Baron TH. Novel endoscopic approaches for assessing biliary tract diseases. Curr Opin Gastroenterol. 2008 May;24(3):357-62. doi: 10.1097/MOG.0b013e3282fad830.

    PubMed 18408465

  • Fukuda Y, Tsuyuguchi T, Sakai Y, Tsuchiya S, Saisyo H. Diagnostic utility of peroral cholangioscopy for various bile-duct lesions. Gastrointest Endosc. 2005 Sep;62(3):374-82. doi: 10.1016/j.gie.2005.04.032.

    PubMed 16111955

  • Kim HJ, Kim MH, Lee SK, Yoo KS, Seo DW, Min YI. Tumor vessel: a valuable cholangioscopic clue of malignant biliary stricture. Gastrointest Endosc. 2000 Nov;52(5):635-8. doi: 10.1067/mge.2000.108969.

    PubMed 11060188

  • Nimura Y, Kamiya J, Hayakawa N, Shionoya S. Cholangioscopic differentiation of biliary strictures and polyps. Endoscopy. 1989 Dec;21 Suppl 1:351-6. doi: 10.1055/s-2007-1012989.

    PubMed 2606085

  • Seo DW, Lee SK, Yoo KS, Kang GH, Kim MH, Suh DJ, Min YI. Cholangioscopic findings in bile duct tumors. Gastrointest Endosc. 2000 Nov;52(5):630-4. doi: 10.1067/mge.2000.108667.

    PubMed 11060187

  • Tamada K, Ueno N, Tomiyama T, Oohashi A, Wada S, Nishizono T, Tano S, Aizawa T, Ido K, Kimura K. Characterization of biliary strictures using intraductal ultrasonography: comparison with percutaneous cholangioscopic biopsy. Gastrointest Endosc. 1998 May;47(5):341-9. doi: 10.1016/s0016-5107(98)70216-0.

    PubMed 9609424

  • Itoi T, Sofuni A, Itokawa F, Tsuchiya T, Kurihara T, Ishii K, Tsuji S, Moriyasu F, Gotoda T. Peroral cholangioscopic diagnosis of biliary-tract diseases by using narrow-band imaging (with videos). Gastrointest Endosc. 2007 Oct;66(4):730-6. doi: 10.1016/j.gie.2007.02.056.

    PubMed 17905015

  • Hoffman A, Kiesslich R, Bittinger F, Galle PR, Neurath MF. Methylene blue-aided cholangioscopy in patients with biliary strictures: feasibility and outcome analysis. Endoscopy. 2008 Jul;40(7):563-71. doi: 10.1055/s-2007-995688. Epub 2008 Apr 11.

    PubMed 18404601

Questions about this trial

What is this clinical trial studying?

A study testing cholangioscopy (Frimberger) in people with Choledocholithiasis and Common Bile Duct Neoplasms, run by Universitätsklinikum Hamburg-Eppendorf at 5 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of cholangioscopy in gallstone therapy and stricture diagnosis (time frame: Patients will be monitored during stay in hospital, average stay is 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01683240, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2016.

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