Hemopatch as a Tool to Prevent Biliary… | Clinical Trial

Key information

Conditions

Biliary Fistula Digestive System Diseases Digestive System Fistula Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Hepatobiliary and General Surgery, Humanitas Research Hospital, University of Milan

Rozzano, Milan, 20089, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

biliary reconstruction
other associated visceral resections

Treatment and study plan

Hemopatch

Procedure

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

Fribrin glue and Tabotamp

Procedure

Fibrin glue and Tabotampis the standard treatment

Other names: Standard treatment

Primary outcomes

The rate of biliary fistula

Time frame: 12 months

Use a Hemopatch to prevent biliary fistula

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Jun 20, 2019
Registry last updated: Apr 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed