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Bile Leak After Liver Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02056028
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : February 5, 2014
Information provided by (Responsible Party):
Prof. Guido Torzilli, University of Milan

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).

Condition or disease Intervention/treatment
Bile Leak Hepatic Resection Liver Resection Hepatectomy Biliary Fistula Procedure: Hepatic resection

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 475 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 90 Days
Official Title: Validation of Our Policy of Long-term Drains Maintenance After Hepatic Resection: Results of a Prospective Cohort Analysis
Study Start Date : January 2004
Actual Primary Completion Date : December 2012
Actual Study Completion Date : February 2014

Group/Cohort Intervention/treatment
Bile leak after hepatic resection Procedure: Hepatic resection
Other Names:
  • Liver resection
  • Hepatectomy

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The records of 475 consecutive patients who were submitted to hepatectomy between 2004-2012 were reviewed.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02056028

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Humanitas Research Hospital
Rozzano, Milan, Italy, 20089
Sponsors and Collaborators
University of Milan
Additional Information:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. Guido Torzilli, Professor of Surgery, University of Milan Identifier: NCT02056028    
Other Study ID Numbers: BileLeakLiverSurgery
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: February 5, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Biliary Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
Digestive System Diseases