Bile Leak After Liver Surgery

Hepatectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02056028
• Other study ID #: BileLeakLiverSurgery
• Status: Completed
• Phase: N/A
• First received: February 3, 2014
• Last updated: February 4, 2014
• Start date: January 2004
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 475
• Est. completion date: February 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bile Leak
• Biliary Fistula
• Hepatectomy
• Hepatic Resection
• Liver Resection

Intervention

Procedure:
• Hepatic resection

Locations

Country	Name	City	State
Italy	Humanitas Research Hospital	Rozzano, Milan

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bile leak	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.	7 days	No
Secondary	ISGLS definition	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.	7 days	No
Secondary	ISGLS definition	Exploration of reliability and efficacy of the International Study Group on Liver Surgery (ISGLS) definition of bile leak after hepatectomy	90 days	No