NCT01003782

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2009

Completed
Last Updated

October 29, 2009

Status Verified

October 1, 2009

Enrollment Period

1.1 years

First QC Date

October 28, 2009

Last Update Submit

October 28, 2009

Conditions

Keywords

cholangitisantibioticbacteriobiliabileERCP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients presenting to Endoscopic retrograde cholangiography

You may qualify if:

  • age above 18 years
  • written informed consent

You may not qualify if:

  • age under 18 years
  • no written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical school

Hanover, 30625, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bile samples for microbiological analysis

MeSH Terms

Conditions

Cholangitis

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 28, 2009

First Posted

October 29, 2009

Study Start

January 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

October 29, 2009

Record last verified: 2009-10

Locations