Clinical trial NCT03993067: Hemopatch as a Tool to Prevent Biliary Fistula in Liver Surgery.
Official title: Hemopatch as a Tool to Prevent Biliary Fistula in Liver Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Fistula
Surgery
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* biliary reconstruction
* other associated visceral resections

Primary outcomes:
measure: The rate of biliary fistula
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Department of Hepatobiliary and General Surgery, Humanitas Research Hospital, University of Milan
state: Milan
Study officials:
affiliation: Department of Biomedical Sciences Humanitas University, Milan
name: Guido Torzilli
role: PRINCIPAL_INVESTIGATOR
References: