Routine Bile Collection for Microbiological Analysis During Cholangiography (ERCP)

This study has been completed.

Sponsor:

Information provided by:

Hannover Medical School

ClinicalTrials.gov Identifier:

NCT01003782

First received: October 28, 2009

Last updated: NA

Last verified: October 2009

History: No changes posted

Tracking Information
First Received Date ^ICMJE	October 28, 2009
Last Updated Date	October 28, 2009
Start Date ^ICMJE	January 2008
Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Routine Bile Collection for Microbiological Analysis During Cholangiography
Official Title ^ICMJE	Routine Bile Collection for Microbiological Analysis During Cholangiography and Its Impact on Management of Cholangitis: Results of a Prospective Study
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
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples Without DNA Description: Bile samples for microbiological analysis
Sampling Method	Probability Sample
Study Population	patients presenting to Endoscopic retrograde cholangiography
Condition ^ICMJE	Cholangitis
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	February 2009
Primary Completion Date	February 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: age above 18 years written informed consent Exclusion Criteria: age under 18 years no written informed consent
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01003782
Other Study ID Numbers ^ICMJE	MAERCP
Has Data Monitoring Committee	No
Responsible Party	Tim Lankisch, Department of Gastroenterology, Hepatology and Endcrinology
Study Sponsor ^ICMJE	Hannover Medical School
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Hannover Medical School
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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