Bile Leak After Liver Surgery

February 4, 2014 updated by: Prof. Guido Torzilli, University of Milan

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

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).

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

475

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

      • Rozzano, Milan, Italy, 20089
        • Humanitas Research Hospital

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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The records of 475 consecutive patients who were submitted to hepatectomy between 2004-2012 were reviewed.

Description

Inclusion Criteria:

  • any patient submitted to hepatic resection at our Unit between the established frame time

Exclusion Criteria:

  • any patient with incomplete data or follow-up

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bile leak after hepatic resection
Other Names:
  • Liver resection
  • Hepatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bile leak
Time Frame: 7 days
The first study endpoint was the ability of our criteria to detect and manage bile leak after liver surgery. For this purpose we considered the rate of bile leaks detected and managed using the surgical drains, and the rate of abdominal collections that required any surgical or radiological intervention after drains removal.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ISGLS definition
Time Frame: 7 days
The second endpoint was the exploration of the ISGLS definition of bile leak in the herein presented cohort of patients in regards of the rate of bile leaks and abdominal collections.
7 days
ISGLS definition
Time Frame: 90 days
Exploration of reliability and efficacy of the International Study Group on Liver Surgery (ISGLS) definition of bile leak after hepatectomy
90 days

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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, 2004

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

February 3, 2014

First Submitted That Met QC Criteria

February 4, 2014

First Posted (Estimate)

February 5, 2014

Study Record Updates

Last Update Posted (Estimate)

February 5, 2014

Last Update Submitted That Met QC Criteria

February 4, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • BileLeakLiverSurgery

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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