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ERCP: Routine Bile Collection for Microbiological Analysis During Cholangiography

Sponsor
Hannover Medical School (Other)
Overall Status
Completed
CT.gov ID
NCT01003782
Collaborator
(none)
1
Location
13
Duration (Months)

Study Details

Study Description

Brief Summary

Background: Antibiotic treatment of cholangitis often remains insufficient due to inappropriate antibiotic use or bacterial resistance.

Objective: To evaluate the role of routine bile collection during endoscopic retrograde cholangiography (ERC) or percutaneous transhepatic cholangiography (PTC) for microbiological analysis in the antibiotic management of cholangitis and to identify risk factors of microbial growth.

Design: Prospective, observational, diagnostic study.

Setting: Hannover Medical School, Hannover, Germany. Patients and Interventions: Consecutive patients undergoing ERC/PTC for biliary complications after orthotopic liver transplantation , malignancy, primary sclerosing cholangitis, benign strictures and choledocholithiasis.

Main outcome measurements: Microbiological examination of bile samples

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Routine Bile Collection for Microbiological Analysis During Cholangiography and Its Impact on Management of Cholangitis: Results of a Prospective Study
    Study Start Date :
    Jan 1, 2008
    Actual Primary Completion Date :
    Feb 1, 2009
    Actual Study Completion Date :
    Feb 1, 2009

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • age above 18 years

      • written informed consent

      Exclusion Criteria:

      • age under 18 years

      • no written informed consent

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Hannover Medical school Hannover Germany 30625

      Sponsors and Collaborators

      • Hannover Medical School

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01003782
      Other Study ID Numbers:
      • MAERCP
      First Posted:
      Oct 29, 2009
      Last Update Posted:
      Oct 29, 2009
      Last Verified:
      Oct 1, 2009
      Keywords provided by , ,
      cholangitis
      antibiotic
      bacteriobilia
      bile
      ERCP
      Additional relevant MeSH terms:
      Cholangitis

      Study Results

      No Results Posted as of Oct 29, 2009