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Completed

NCT Number: NCT02056028

Bile Leak After Liver Surgery

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).

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Key information

Conditions

Bile Leak Biliary Fistula Digestive System Diseases Digestive System Fistula Fistula Hepatectomy Hepatic Resection Liver Resection Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hepatic resection

Procedure

Other names: Liver resection, Hepatectomy

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2012
Study completion
2014
First posted
Feb 5, 2014
Registry last updated
Feb 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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