- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02056028
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
Status
Completed
Intervention / Treatment
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
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Rozzano, Milan, Italy, 20089
- Humanitas Research Hospital
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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 |
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Bile leak after hepatic resection
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bile leak
Time Frame: 7 days
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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.
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7 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ISGLS definition
Time Frame: 7 days
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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.
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7 days
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ISGLS definition
Time Frame: 90 days
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Exploration of reliability and efficacy of the International Study Group on Liver Surgery (ISGLS) definition of bile leak after hepatectomy
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90 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
General Publications
- Torzilli G, Olivari N, Del Fabbro D, Gambetti A, Leoni P, Gendarini A, Makuuchi M. Bilirubin level fluctuation in drain discharge after hepatectomies justifies long-term drain maintenance. Hepatogastroenterology. 2005 Jul-Aug;52(64):1206-10.
- Donadon M, Costa G, Cimino M, Procopio F, Del Fabbro D, Palmisano A, Torzilli G. Diagnosis and Management of Bile Leaks After Hepatectomy: Results of a Prospective Analysis of 475 Hepatectomies. World J Surg. 2016 Jan;40(1):172-81. doi: 10.1007/s00268-015-3143-0.
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
Additional Relevant MeSH Terms
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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