Routine Bile Collection for Microbiological Analysis During Cholangiography (ERCP)

October 28, 2009 updated by: Hannover Medical School

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hannover, Germany, 30625
        • Hannover Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients presenting to Endoscopic retrograde cholangiography

Description

Inclusion Criteria:

  • age above 18 years
  • written informed consent

Exclusion Criteria:

  • age under 18 years
  • no written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

October 28, 2009

First Submitted That Met QC Criteria

October 28, 2009

First Posted (Estimate)

October 29, 2009

Study Record Updates

Last Update Posted (Estimate)

October 29, 2009

Last Update Submitted That Met QC Criteria

October 28, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAERCP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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