Biliary FistulaNCT03993067
Hemopatch as a Tool to Prevent Biliary Fistula in Liver Surgery.
A study testing Hemopatch and Fribrin glue and Tabotamp in people with Biliary Fistula and Surgery, run by University of Milan at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Fistula, Surgery
- What is being tested?
- Hemopatch and Fribrin glue and Tabotamp
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteItaly
- Study dates
- 15 Nov 2018to 15 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients submitted to liver surgery for malignancies.
- >18 years of age.
Who cannot join
- biliary reconstruction
- other associated visceral resections
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Hepatobiliary and General Surgery, Humanitas Research Hospital, University of Milan
Rozzano, Milan, 20089
About this study
The aim of the study is to investigate the use of Hemopatch to prevent biliary fistula in patients submitted to surgery for malignancy.
Read the 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.
- Conditions
- Biliary Fistula, Surgery
- Being tested
- Hemopatch, Fribrin glue and Tabotamp
- Medical subject headings
- Biliary Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemopatchProcedure or surgery
Also called Experimental
Hemopatch is a collagen based sealant is a hemostat agent. We want to investigate his role in the prevention of post operative biliary fistula
Fribrin glue and TabotampProcedure or surgery
Also called Standard treatment
Fibrin glue and Tabotampis the standard treatment
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment | Active comparator | Fibrin glue and Tabotamp on cut surface Receives: Procedure: Fribrin glue and Tabotamp |
| Hemopatch | Experimental | Hemopatch on cut surface Receives: Procedure: Hemopatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of biliary fistula
Use a Hemopatch to prevent biliary fistula
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start15 Nov 2018
- Primary completion15 Jan 2020
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Guido Torzilli, University of Milan
- Investigators
- Guido Torzilli, Principal investigator, Department of Biomedical Sciences Humanitas University, Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993067
- Sponsor's protocol ID
- HBF2018
- Status last verified
- Apr 2021
- First submitted
- 19 Jun 2019
- Last updated
- 6 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemopatch as a Tool to Prevent Biliary Fistula in Liver Surgery.
- ClinicalTrials.gov ID
- NCT03993067
- Acronym / sponsor ID
- HBF2018
- Conditions
- Biliary Fistula, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment | Active comparator | Procedure: Fribrin glue and TabotampFibrin glue and Tabotamp on cut surface |
| Hemopatch | Experimental | Procedure: HemopatchHemopatch on cut surface |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- all patients submitted to liver surgery for malignancies.
- >18 years of age.
Key exclusion criteria (2 listed)
- biliary reconstruction
- other associated visceral resections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemopatchAlso: ExperimentalHemopatch is a collagen based sealant is a hemostat agent. We want to investigate his role in the prevention of post operative biliary fistula | Procedure or surgery | Hemopatch |
| Fribrin glue and TabotampAlso: Standard treatmentFibrin glue and Tabotampis the standard treatment | Procedure or surgery | Standard Treatment |
Primary outcome
The rate of biliary fistula
Time frame: 12 months
Use a Hemopatch to prevent biliary fistula
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guido Torzilli principal investigator
Department of Biomedical Sciences Humanitas University, Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemopatch and Fribrin glue and Tabotamp in people with Biliary Fistula and Surgery, run by University of Milan at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of biliary fistula (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021; AzTrials last refreshed its copy on 6 Nov 2026.