NCT01683240

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 11, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

May 11, 2016

Status Verified

May 1, 2016

Enrollment Period

5 years

First QC Date

July 6, 2012

Last Update Submit

May 10, 2016

Conditions

CholedocholithiasisCommon Bile Duct NeoplasmsCholestasis

Keywords

cholangiographycholangioscopymother-babycholangioscopeFrimberger cholangioscopeshort access cholangioscopyERCPgallstone therapy

Outcome Measures

Primary Outcomes (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)

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

Secondary Outcomes (3)

  • Complication rate

    while examination and 24 hrs past examination

  • Gallstone therapy

    procedure, average procedure time 1 hour

  • Stricture diagnostic

    procedure, average procedure time is 1 hour

Study Arms (1)

Frimberger cholangioscope

EXPERIMENTAL

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

Device: cholangioscopy (Frimberger)

Interventions

cholangioscopy (Frimberger)DEVICE

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

Frimberger cholangioscope

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Charité Universitätsmedizin, Virchow Klinikum

Berlin, 13353, Germany

Location

University Hospital Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Asklepios Klinik Hamburg Barmbek

Hamburg, 22291, Germany

Location

Israelitisches Krankenhaus

Hamburg, 22297, Germany

Location

Asklepios Klinik Hamburg Altona

Hamburg, 22763, Germany

Location

Related Publications (12)

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

    PMID: 19853234BACKGROUND

  • 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.

    PMID: 16547668BACKGROUND

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

    PMID: 19381085BACKGROUND

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

    PMID: 18922458BACKGROUND

  • 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.

    PMID: 18408465BACKGROUND

  • 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.

    PMID: 16111955BACKGROUND

  • 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.

    PMID: 11060188BACKGROUND

  • 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.

    PMID: 2606085BACKGROUND

  • 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.

    PMID: 11060187BACKGROUND

  • 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.

    PMID: 9609424BACKGROUND

  • 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.

    PMID: 17905015BACKGROUND

  • 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.

    PMID: 18404601BACKGROUND

MeSH Terms

Conditions

CholedocholithiasisCommon Bile Duct NeoplasmsCholestasis

Condition Hierarchy (Ancestors)

Common Bile Duct DiseasesBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesCholelithiasisBile Duct NeoplasmsBiliary Tract NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Thomas Rösch, Prof. Dr.

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2012

First Posted

September 11, 2012

Study Start

February 1, 2011

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

May 11, 2016

Record last verified: 2016-05

Locations

DE(5)