Bile Leak After Liver Surgery

Completed

• Conditions: Hepatic Resection; Liver Resection; Hepatectomy; Biliary Fistula; Bile Leak
• Interventions: Procedure: Hepatic resection

• Registration Number: NCT02056028
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2004-01
• Primary Completion: 2012-12
• Status Verified: 2014-02
• Study Completion: 2014-02
• Study First Submitted: 2014-02-03
• Study First Submitted QC: 2014-02-04
• Last Update Submitted: 2014-02-04
• Study First Posted: 2014-02-05
• Last Update Posted: 2014-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 475

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bile leak after hepatic resection	Hepatic resection	-

Primary Outcome Measures

Name	Time	Method
Bile leak	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

Name	Time	Method
ISGLS definition	90 days	Exploration of reliability and efficacy of the International Study Group on Liver Surgery (ISGLS) definition of bile leak after hepatectomy

Trial Locations

Locations (1)

Humanitas Research Hospital; 🇮🇹 Rozzano, Milan, Italy