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

Not Applicable

Completed

• Conditions: Biliary Fistula; Surgery
• Interventions: Procedure: Hemopatch; Procedure: Fribrin glue and Tabotamp

• Registration Number: NCT03993067
• Lead Sponsor: University of Milan

Brief Summary

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

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 Timeline

• Study Start: 2018-11-15
• Study First Submitted: 2019-06-19
• Study First Submitted QC: 2019-06-19
• Study First Posted: 2019-06-20
• Primary Completion: 2020-01-15
• Study Completion: 2020-01-15
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-02
• Last Update Posted: 2021-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

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

Exclusion Criteria

• biliary reconstruction
• other associated visceral resections

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hemopatch	Hemopatch	Hemopatch on cut surface
Standard Treatment	Fribrin glue and Tabotamp	Fibrin glue and Tabotamp on cut surface

Primary Outcome Measures

Name	Time	Method
The rate of biliary fistula	12 months	Use a Hemopatch to prevent biliary fistula

Trial Locations

Locations (1)

Department of Hepatobiliary and General Surgery, Humanitas Research Hospital, University of Milan; 🇮🇹 Rozzano, Milan, Italy