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Routine Bile Collection for Microbiological Analysis During Cholangiography (ERCP)

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ClinicalTrials.gov Identifier: NCT01003782
Recruitment Status : Completed
First Posted : October 29, 2009
Last Update Posted : October 29, 2009
Sponsor:
Information provided by:
Hannover Medical School

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
Cholangitis

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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 : January 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009



Biospecimen Retention:   Samples Without DNA
Bile samples for microbiological analysis


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients presenting to Endoscopic retrograde cholangiography
Criteria

Inclusion Criteria:

  • age above 18 years
  • written informed consent

Exclusion Criteria:

  • age under 18 years
  • no written informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01003782


Locations
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Germany
Hannover Medical school
Hannover, Germany, 30625
Sponsors and Collaborators
Hannover Medical School

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Responsible Party: Tim Lankisch, Department of Gastroenterology, Hepatology and Endcrinology
ClinicalTrials.gov Identifier: NCT01003782     History of Changes
Other Study ID Numbers: MAERCP
First Posted: October 29, 2009    Key Record Dates
Last Update Posted: October 29, 2009
Last Verified: October 2009

Keywords provided by Hannover Medical School:
cholangitis
antibiotic
bacteriobilia
bile
ERCP

Additional relevant MeSH terms:
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Cholangitis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases