An observational study in Bile Leak, Hepatic Resection and Liver Resection, sponsored by University of Milan. Completed at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2014-02-05.
Sponsored by University of Milan · Observational
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).
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.
University of Milan is the lead sponsor of 182 studies on the registry; 28 are open to participants now.
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The records of 475 consecutive patients who were submitted to hepatectomy between 2004-2012 were reviewed.
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Exclusion Criteria:
Procedure: Hepatic resection
Also known as: Liver resection, Hepatectomy
Bile leak
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.
Time frame: 7 days
ISGLS definition
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.
Time frame: 7 days
ISGLS definition
Exploration of reliability and efficacy of the International Study Group on Liver Surgery (ISGLS) definition of bile leak after hepatectomy
Time frame: 90 days
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Biliary Fistula