Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03993067 |
| Other study ID # |
HBF2018 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 15, 2018 |
| Est. completion date |
January 15, 2020 |
Study information
| Verified date |
April 2021 |
| Source |
University of Milan |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of the study is to investigate the use of Hemopatch to prevent biliary fistula in
patients submitted to surgery for malignancy.
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.
