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Bile Leak After Liver Surgery

NCT ID: NCT02056028

Last Updated: 2014-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

475 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-01-31

Study Completion Date

2014-02-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Bile Leak Hepatic Resection Liver Resection Hepatectomy Biliary Fistula

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Bile leak after hepatic resection

Hepatic resection

Intervention Type PROCEDURE

Interventions

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Hepatic resection

Intervention Type PROCEDURE

Other Intervention Names

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Liver resection Hepatectomy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Milan

OTHER

Sponsor Role lead

Responsible Party

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Prof. Guido Torzilli

Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Humanitas Research Hospital

Rozzano, Milan, , Italy

Site Status

Countries

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Italy

References

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Torzilli G, Olivari N, Del Fabbro D, Gambetti A, Leoni P, Gendarini A, Makuuchi M. Bilirubin level fluctuation in drain discharge after hepatectomies justifies long-term drain maintenance. Hepatogastroenterology. 2005 Jul-Aug;52(64):1206-10.

Reference Type BACKGROUND
PMID: 16001662 (View on PubMed)

Donadon M, Costa G, Cimino M, Procopio F, Del Fabbro D, Palmisano A, Torzilli G. Diagnosis and Management of Bile Leaks After Hepatectomy: Results of a Prospective Analysis of 475 Hepatectomies. World J Surg. 2016 Jan;40(1):172-81. doi: 10.1007/s00268-015-3143-0.

Reference Type DERIVED
PMID: 26148518 (View on PubMed)

Other Identifiers

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BileLeakLiverSurgery

Identifier Type: -

Identifier Source: org_study_id

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