Clinical Trials Directory

Trials / Completed

CompletedNCT02056028

Bile Leak After Liver Surgery

Validation of Our Policy of Long-term Drains Maintenance After Hepatic Resection: Results of a Prospective Cohort Analysis

Status
Completed
Phase
Study type
Observational
Enrollment
475 (actual)
Sponsor
University of Milan · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

Summary

The definition of biliary fistula is heterogeneous and the more accepted is that proposed by the ISGLS. We devised a precise definition of post-resectional biliary fistula and a well-established policy both for its disclosure and management.Aim was the validation of our definition, and management of biliary fistula after hepatic resection in a large prospective cohort of patients and its comparison with that of the International Study Group of Liver Surgery (ISGLS).

Detailed description

Data on abdominal drains and on clinical, pathological and short-term outcome were reviewed in a prospective cohort of patients who underwent hepatic resection between 2004 and 2012. Drains were maintained at least 7 days, and the bilirubin levels were measured in POD3, 5, and 7. Drains were removed if the bilirubin level in POD7 was inferior than in POD5, and less than 10 mg/dl. Statistical analysis on prognostic factors for biliary fistula was performed.

Conditions

Interventions

TypeNameDescription
PROCEDUREHepatic resection

Timeline

Start date
2004-01-01
Primary completion
2012-12-01
Completion
2014-02-01
First posted
2014-02-05
Last updated
2014-02-05

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT02056028. Inclusion in this directory is not an endorsement.