Bile Leak After Liver Surgery

• ClinicalTrials.gov Identifier: NCT02056028
• Recruitment Status: Completed
• First Posted: February 5, 2014
• Last Update Posted: February 5, 2014
• Sponsor: University of Milan
• Information provided by (Responsible Party): Prof. Guido Torzilli, University of Milan

Study Description

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.

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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

Eligibility Criteria

• 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.

Criteria

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

Contacts and Locations

Locations

Italy

Humanitas Research Hospital

Rozzano, Milan, Italy, 20089

Sponsors and Collaborators

University of Milan

More Information

Additional Information:

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Prof. Guido Torzilli, Professor of Surgery, University of Milan
• ClinicalTrials.gov Identifier: NCT02056028
• Other Study ID Numbers: BileLeakLiverSurgery
• First Posted: February 5, 2014
• Last Update Posted: February 5, 2014
• Last Verified: February 2014

Additional relevant MeSH terms:

Biliary Fistula; Fistula; Pathological Conditions, Anatomical; Digestive System Fistula; Digestive System Diseases