Hemopatch as a Tool to Prevent Biliary Fistula in Liver Surgery.

The aim of the study is to investigate the use of Hemopatch to prevent biliary fistula in patients submitted to surgery for malignancy.

Study Overview

• Status: Completed
• Conditions: Surgery; Biliary Fistula
• Intervention / Treatment: Procedure: Fribrin glue and Tabotamp; Procedure: Hemopatch

Detailed Description

Background: Biliary fistula (BF) is one of the most common sources of post hepatectomy morbidity. International Study Group of Liver Surgery (ISGLS) define BF as increased bilirubin concentration in the drain at least 3 times greater than the serum bilirubin concentration on or after postoperative day (POD) 3. BF is graded into grade A, B and C, based on the clinical impact on the postoperative course. Considering ISGLS definition, the incidence of BF ranges from 4,4% to 27,2%. The definition developed in Humanitas Research Hospital (HRH), defines BF as bilirubin concentration in the drain fluid greater than 10 mg/dL on or after POD 3. In this case, the incidence is around 8%. Various topical haemostatic agents have been developed for liver resection area management their usefulness in preventing BF by using a sealing product on the resection surface still remains unclear and needs to be assessed.

Objective: this study aimed to assess the clinical validation of Hemopatch to prevent post-operative biliary fistula. Secondarily, it is aimed to evaluate the clinical validity of the two proposed definition of biliary fistula.

Methods: According to the incidence of BF in our previous series (considering ISGLS definition), we designed a randomized controlled study on 220 patients, who underwent hepatic resection from 2018 to 2020. Patients were randomized to treatment group A (Hemopatch) and standard group B (Tisseal and Tabotamp). Both ISGLS and HRH definitions of BF were considered. All patients were systematically drained. Drains were maintained at least 5 days, and bilirubin was measured on PODs 3, 5, and 7. Drains were removed if the bilirubin concentration in the drain fluid was less than 10 mg/dL on POD 7. A statistical analysis to compare perioperative variables between two groups was performed. Then, a multivariate analysis was performed to identify potential risk factors for BF.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan
    • Rozzano, Milan, Italy, 20089
      • Department of Hepatobiliary and General Surgery, Humanitas Research Hospital, University of Milan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• all patients submitted to liver surgery for malignancies.
• >18 years of age.

Exclusion Criteria:

• biliary reconstruction
• other associated visceral resections

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Standard Treatment; Fibrin glue and Tabotamp on cut surface	Procedure: Fribrin glue and Tabotamp; Fibrin glue and Tabotampis the standard treatment; Other Names: Standard treatment
EXPERIMENTAL: Hemopatch; Hemopatch on cut surface	Procedure: Hemopatch; Hemopatch is a collagen based sealant is a hemostat agent. We want to investigate his role in the prevention of post operative biliary fistula; Other Names: Experimental

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of biliary fistula	Use a Hemopatch to prevent biliary fistula	12 months

Collaborators and Investigators

• Sponsor: University of Milan
• Investigators: Principal Investigator: Guido Torzilli, Department of Biomedical Sciences Humanitas University, Milan

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 15, 2018
• Primary Completion (ACTUAL): January 15, 2020
• Study Completion (ACTUAL): January 15, 2020

Study Registration Dates

• First Submitted: June 19, 2019
• First Submitted That Met QC Criteria: June 19, 2019
• First Posted (ACTUAL): June 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2021
• Last Update Submitted That Met QC Criteria: April 2, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Digestive System Fistula; Fistula; Biliary Fistula
• Other Study ID Numbers: HBF2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No