Bile LeakNCT04665427
Factors Influencing Occurrence of Bile Leaks in Surgery
A study testing bilioenteric anastomosis i in people with Bile Leak and Anastomotic Leak Biliary, run by University of Oran 1 at 1 site in Algeria.
Trial summary
The objective of our study is to identify the factors influencing the occurrence of a biliary leak after performing surgery leading to the creation of a biliary anastomosis to any segment of the digestive tract. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bile Leak, Anastomotic Leak Biliary, Biliary Tract Fistula
- What is being tested?
- bilioenteric anastomosis i
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteAlgeria
- Study dates
- 18 Nov 2020to 1 Aug 2022
- 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
- Any patient who has undergone a surgical bilioenteric anastomosis for any etiology.
Who cannot join
- Any patient who has undergone a nonsurgical (endoscopic / radiological) bilioenteric anastomosis.
- Subjects under the age of 18. Years.
- Subjects who refused to participate in this study.
- Cases of biliary and pancreatic anastomoses performed during the same surgery.
Trial locations and contacts
1 site in 1 country.
Algeria1 site
Departmenet of hepatobiliary surgery, EHU-1st November 1954, Oran.
Oran, 31000
About this study
Official title: Factors That Influence the Occurrence of Bile Leaks After Biliary Anastomosis Surgery
The objective of our study is to identify the factors influencing the occurrence of a biliary leak after performing surgery leading to the creation of a biliary anastomosis to any segment of the digestive tract.
Read the detailed description
The objective of our study is to identify the factors influencing the occurrence postoperative of biliary leaks, Sex, Age, BMI, Bilirubin level, Protein level, and surgical technique (And other factors)are analyzed to study their influence on occurrence of postoperative biliary leak.
- Conditions
- Bile Leak, Anastomotic Leak Biliary, Biliary Tract Fistula
- Being tested
- bilioenteric anastomosis i
- Keywords
- hepatobiliary surgery, Morbidity, leak, anastomosis
- Medical subject headings
- Biliary Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilioenteric anastomosis iOther
Also called hepatico duodenostomy, hepaticojejunostomy
The creation of communication between a bile duct and a segment of the digestive tract, often to restore a flow of bile in the digestive tract,
| Study group | Role | What they receive |
|---|---|---|
| Patient in whom a bilioenteric anastomosis is performed for any etiology. | Other | Patient in whom a bilioenteric anastomosis is performed for any etiology.. Receives: Other: bilioenteric anastomosis i |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of a bile leak in the postoperative period (Day 0 to Day 90).
Occurrence of a bile leak visible through a drain, through the wound, visible on the control radiology, or after the occurrence of a peritoneal collection or biliary peritonitis.
Measured: From (day 0) of surgery to (day 90)
Secondary outcomes (2)
Postoperative hospital stay
length of postoperative hospital stay
Measured: From (day 0) of surgery to (day 90)
Mortality
Mortality after surgery
Measured: From day 0 to day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start18 Nov 2020
- Primary completion18 Jul 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oran 1
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anisse Tidjane, University of Oran 1
- Investigators
- Benali Tabeti, Pr, Study chair, University Oran1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665427
- Sponsor's protocol ID
- UOran1_surgery_Bile_leak
- Status last verified
- Jun 2024
- First submitted
- 29 Nov 2020
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors That Influence the Occurrence of Bile Leaks After Biliary Anastomosis Surgery
- ClinicalTrials.gov ID
- NCT04665427
- Acronym / sponsor ID
- UOran1_surgery_Bile_leak
- Conditions
- Bile Leak, Anastomotic Leak Biliary, Biliary Tract Fistula
- Keywords
- hepatobiliary surgery, Morbidity, leak, anastomosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of Oran 1University, hospital or other
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 18 Jul 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 11 Dec 2020 (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 objective of our study is to identify the factors influencing the occurrence of a biliary leak after performing surgery leading to the creation of a biliary anastomosis to any segment of the digestive tract.
Detailed description
The objective of our study is to identify the factors influencing the occurrence postoperative of biliary leaks, Sex, Age, BMI, Bilirubin level, Protein level, and surgical technique (And other factors)are analyzed to study their influence on occurrence of postoperative biliary leak.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient in whom a bilioenteric anastomosis is performed for any etiology. | Other | Other: bilioenteric anastomosis iPatient in whom a bilioenteric anastomosis is performed for any etiology.. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient who has undergone a surgical bilioenteric anastomosis for any etiology.
Key exclusion criteria (4 listed)
- Any patient who has undergone a nonsurgical (endoscopic / radiological) bilioenteric anastomosis.
- Subjects under the age of 18. Years.
- Subjects who refused to participate in this study.
- Cases of biliary and pancreatic anastomoses performed during the same surgery.
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 |
|---|---|---|
| bilioenteric anastomosis iAlso: hepatico duodenostomy, hepaticojejunostomyThe creation of communication between a bile duct and a segment of the digestive tract, often to restore a flow of bile in the digestive tract, | Other | Patient in whom a bilioenteric anastomosis is performed for any etiology. |
Primary outcome
The occurrence of a bile leak in the postoperative period (Day 0 to Day 90).
Time frame: From (day 0) of surgery to (day 90)
Occurrence of a bile leak visible through a drain, through the wound, visible on the control radiology, or after the occurrence of a peritoneal collection or biliary peritonitis.
2 secondary outcomes
Postoperative hospital stay
Time frame: From (day 0) of surgery to (day 90)
Mortality
Time frame: From day 0 to day 90
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 25 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Bile Leak
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Routine White Test for Early Detection of Bile Leak in Elective Liver Resection (DELiveR Trial)
Bile Leak, Liver Resection
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Impact of Intraoperative PTCD Catheter Retention Versus Removal on Postoperative Short-term Outcomes After Pancreaticoduodenectomy in Obstructive Jaundice
Obstructive Jaundice, Pancreatic Head Cancer
Active, not recruitingObservational study
The Need for Repeat ERCP After Endoscopic Treatment of Postsurgical Biliary Leaks
Bile Leak
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Organoids for Bile Leaks
Biliary Anastomosis Complication
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.
Benali Tabeti, Pr study chair
University Oran1
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bilioenteric anastomosis i in people with Bile Leak and Anastomotic Leak Biliary, run by University of Oran 1 at 1 site in Algeria.
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 4 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 25 Jun 2024. 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 Algeria. 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 occurrence of a bile leak in the postoperative period (Day 0 to Day 90). (time frame: From (day 0) of surgery to (day 90)). 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 25 Jun 2024.