Bile LeakNCT02056028
Bile Leak After Liver Surgery
An observational study of Bile Leak and Hepatic Resection, run by University of Milan at 1 site in Italy.
Trial summary
The definition of biliary fistula is heterogeneous and the more accepted is that proposed by the ISGLS. We devised a precise definition of post-resectional biliary fistula and a well-established policy both for its disclosure and management.Aim was the validation of our definition, and management of biliary fistula… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bile Leak, Hepatic Resection, Liver Resection
- What is being tested?
- Hepatic resection
- Type of treatment
- Surgery or procedure
- How many people
- 475 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2004to Feb 2014
- How long will I take part?
- 90 Days
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The records of 475 consecutive patients who were submitted to hepatectomy between 2004-2012 were reviewed.
Who may be able to join
- any patient submitted to hepatic resection at our Unit between the established frame time
Who cannot join
- any patient with incomplete data or follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Our Policy of Long-term Drains Maintenance After Hepatic Resection: Results of a Prospective Cohort Analysis
The definition of biliary fistula is heterogeneous and the more accepted is that proposed by the ISGLS. We devised a precise definition of post-resectional biliary fistula and a well-established policy both for its disclosure and management.Aim was the validation of our definition, and management of biliary fistula after hepatic resection in a large prospective cohort of patients and its comparison with that of the International Study Group of Liver Surgery (ISGLS).
Read the detailed description
Data on abdominal drains and on clinical, pathological and short-term outcome were reviewed in a prospective cohort of patients who underwent hepatic resection between 2004 and 2012. Drains were maintained at least 7 days, and the bilirubin levels were measured in POD3, 5, and 7. Drains were removed if the bilirubin level in POD7 was inferior than in POD5, and less than 10 mg/dl. Statistical analysis on prognostic factors for biliary fistula was performed.
- Conditions
- Bile Leak, Hepatic Resection, Liver Resection, Hepatectomy, Biliary Fistula
- Being tested
- Hepatic resection
- Medical subject headings
- Biliary Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatic resectionProcedure or surgery
Also called Liver resection, Hepatectomy
| Study group | Role | What they receive |
|---|---|---|
| Bile leak after hepatic resection | Not described Receives: Procedure: Hepatic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bile leak
The first study endpoint was the ability of our criteria to detect and manage bile leak after liver surgery. For this purpose we considered the rate of bile leaks detected and managed using the surgical drains, and the rate of abdominal collections that required any surgical or radiological intervention after drains removal.
Measured: 7 days
Secondary outcomes (2)
ISGLS definition
The second endpoint was the exploration of the ISGLS definition of bile leak in the herein presented cohort of patients in regards of the rate of bile leaks and abdominal collections.
Measured: 7 days
ISGLS definition
Exploration of reliability and efficacy of the International Study Group on Liver Surgery (ISGLS) definition of bile leak after hepatectomy
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study startJan 2004
- Primary completionDec 2012
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bile LeakStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 475 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Guido Torzilli, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056028
- Sponsor's protocol ID
- BileLeakLiverSurgery
- Status last verified
- Feb 2014
- First submitted
- 3 Feb 2014
- Last updated
- 5 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Torzilli G, Olivari N, Del Fabbro D, Gambetti A, Leoni P, Gendarini A, Makuuchi M. Bilirubin level fluctuation in drain discharge after hepatectomies justifies long-term drain maintenance. Hepatogastroenterology. 2005 Jul-Aug;52(64):1206-10.
PubMed 16001662Donadon M, Costa G, Cimino M, Procopio F, Del Fabbro D, Palmisano A, Torzilli G. Diagnosis and Management of Bile Leaks After Hepatectomy: Results of a Prospective Analysis of 475 Hepatectomies. World J Surg. 2016 Jan;40(1):172-81. doi: 10.1007/s00268-015-3143-0.
PubMed 26148518
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Our Policy of Long-term Drains Maintenance After Hepatic Resection: Results of a Prospective Cohort Analysis
- ClinicalTrials.gov ID
- NCT02056028
- Acronym / sponsor ID
- BileLeakLiverSurgery
- Conditions
- Bile Leak, Hepatic Resection, Liver Resection, Hepatectomy, Biliary Fistula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 5 Feb 2014 (estimated)
- 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 definition of biliary fistula is heterogeneous and the more accepted is that proposed by the ISGLS. We devised a precise definition of post-resectional biliary fistula and a well-established policy both for its disclosure and management.Aim was the validation of our definition, and management of biliary fistula after hepatic resection in a large prospective cohort of patients and its comparison with that of the International Study Group of Liver Surgery (ISGLS).
Detailed description
Data on abdominal drains and on clinical, pathological and short-term outcome were reviewed in a prospective cohort of patients who underwent hepatic resection between 2004 and 2012. Drains were maintained at least 7 days, and the bilirubin levels were measured in POD3, 5, and 7. Drains were removed if the bilirubin level in POD7 was inferior than in POD5, and less than 10 mg/dl. Statistical analysis on prognostic factors for biliary fistula was performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bile leak after hepatic resection | – | Procedure: Hepatic resection |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The records of 475 consecutive patients who were submitted to hepatectomy between 2004-2012 were reviewed.
Key inclusion criteria (1 listed)
- any patient submitted to hepatic resection at our Unit between the established frame time
Key exclusion criteria (1 listed)
- any patient with incomplete data or follow-up
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 |
|---|---|---|
| Hepatic resectionAlso: Liver resection, Hepatectomy | Procedure or surgery | Bile leak after hepatic resection |
Primary outcome
Bile leak
Time frame: 7 days
The first study endpoint was the ability of our criteria to detect and manage bile leak after liver surgery. For this purpose we considered the rate of bile leaks detected and managed using the surgical drains, and the rate of abdominal collections that required any surgical or radiological intervention after drains removal.
2 secondary outcomes
ISGLS definition
Time frame: 7 days
ISGLS definition
Time frame: 90 days
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 5 Feb 2014.
- Background: PubMed 16001662Torzilli G, Olivari N, Del Fabbro D, Gambetti A, Leoni P, Gendarini A, Makuuchi M. Bilirubin level fluctuation in drain discharge after hepatectomies justifies long-term drain maintenance. Hepatogastroenterology. 2005 Jul-Aug;52(64):1206-10.
- Derived from this study: PubMed 26148518Donadon M, Costa G, Cimino M, Procopio F, Del Fabbro D, Palmisano A, Torzilli G. Diagnosis and Management of Bile Leaks After Hepatectomy: Results of a Prospective Analysis of 475 Hepatectomies. World J Surg. 2016 Jan;40(1):172-81. doi: 10.1007/s00268-015-3143-0.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bile Leak and Hepatic Resection, 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 1 inclusion and 1 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 5 Feb 2014. 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?
Bile leak (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02056028, which also lists 2 linked publications.
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 5 Feb 2014.