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NCT01003782 Clinical Trial

Routine Bile Collection for Microbiological Analysis During Cholangiography

Cholangitis Clinical Trial

— ERCP  

Official title:
Routine Bile Collection for Microbiological Analysis During Cholangiography and Its Impact on Management of Cholangitis: Results of a Prospective Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01003782
Other study ID # MAERCP
Secondary ID
Status Completed
Phase N/A
First received October 28, 2009
Last updated October 28, 2009
Start date January 2008
Est. completion date February 2009

Study information
Verified date October 2009
Source Hannover Medical School
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Ministry of Education and Research
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date February 2009
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- age above 18 years

- written informed consent

Exclusion Criteria:

- age under 18 years

- no written informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Hannover Medical school Hannover

Sponsors (1)
Lead Sponsor Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

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