Clinical Trial: Bile Leak After Liver Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Observational [Patient Registry]

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

Brief 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 Summary: 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.
Sponsor: University of Milan

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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


Original Secondary Outcome: Same as current

Information By: University of Milan

Dates:
Date Received: February 3, 2014
Date Started: January 2004
Date Completion:
Last Updated: February 4, 2014
Last Verified: February 2014