Bile Duct InjuryNCT04286763
Factors Influencing Occurrence Of Hilar Biliary Stricture In Case of Bile Duct Injury
An observational study of Bile Duct Injury, run by University of Oran 1 at 1 site in Algeria.
Trial summary
The bile duct injury is a complication that occurs mainly after the cholecystectomy. Bile duct stricture is one of complications of this unwitting iatrogenic injury, the outcomes of surgery in this case are worse when the level of the stricture is above the helium. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bile Duct Injury
- What is being tested?
- Biliary RMI and CT scan.
- How many people
- 53 participants
- Where
- 1 siteAlgeria
- Study dates
- 1 Jan 2010to 30 Sep 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All cases of biliary structure admitted for the management of an operative bile duct injury in the hepatobiliary surgery and liver transplant department of EHU-1st November 1954 / Oran, Algeria. No geographic origin is excluded, patients are admitted in our department following a meducal consultation, a medical orientation or an emergency evacuation. Any patient meeting the inclusion criteria is eligible for this study after informed consent concerning the use of their personal data for research purposes with respect for anonymity and professional secrecy.
Who may be able to join
- all cases with biliary stricture following an operative bile duct injury.
Who cannot join
- cases of biliary stricture following an non operative bile duct injury (Blind or penetrating abdominal trauma , radiological or endoscopic maneuvers).
- cases of biliary stricture following hepatectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Factors Influencing Occurence Of Hight Level of Biliary Stricture Due to Operative Bile Duct Injury
The bile duct injury is a complication that occurs mainly after the cholecystectomy. Bile duct stricture is one of complications of this unwitting iatrogenic injury, the outcomes of surgery in this case are worse when the level of the stricture is above the helium.
So what are factors influencing the occurrence of this high level bile duct obstruction ?
Read the detailed description
The objective of this study was to answer a simple question, what are the factors influencing the occurrence of high level -called hilar biliary stricture? To answer this question, a retrospective study was carried out on the files of patients operated for biliary stenosis after operative trauma of the bile ducts in our department over a period from January 2010 to May 2018. Only patients operated in biliary stricture (Grade E Strasberg) was included.
A univariate and muntivariate logistic regression analysis was performed to determine the factors influencing the occurrence of hilar stenosis. data entry and analysis was done using SPSS V20.0 software.
- Conditions
- Bile Duct Injury
- Being tested
- Biliary RMI and CT scan.
- Keywords
- bile duct injury, surgery, laparoscopy, cholecystectomy, Bile duct stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biliary RMI and CT scan.Diagnostic test
For a good appreciation of the anatomy of the biliary lesion, an MRI was systematically performed on all our patients.
For a good appreciation of the presence of an associated vascular lesion, a CT-scan was systematically performed on all our patients.
| Study group | Role | What they receive |
|---|---|---|
| Hilar stricture | Bile duct Stricture (corresponding to E3, E4 and E5 from of Strasberg. -According to the classification proposed by Strasberg of operative bile duct injuries). Receives: Diagnostic Test: Biliary RMI and CT scan. | |
| Low level Stricture | Bile duct Stricture (corresponding to E1 and E2 from Strasberg. -According to the classification proposed by Strasberg of operative bile duct injuries). Receives: Diagnostic Test: Biliary RMI and CT scan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors influencing occurrence of hilar stricture (E3,E4,E5)
all the variables related to the patient, his disease and the course of the surgical intervention which caused the biliary trauma was recorded.
Measured: from the date of the surgery that caused the biliary injury to the date of transfer to our structure for treatment. in our series, the period varies from 8 weeks to 10 years after the occurrence of operative bile duct injury during initial surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start1 Jan 2010
- Primary completion1 May 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile Duct InjuryStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 53 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
- Noureddine Benmaarouf, Pr, Study director, University of Oran 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286763
- Sponsor's protocol ID
- UOran1bileductinjury
- Status last verified
- Feb 2020
- First submitted
- 20 Feb 2020
- Last updated
- 27 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing Occurence Of Hight Level of Biliary Stricture Due to Operative Bile Duct Injury
- ClinicalTrials.gov ID
- NCT04286763
- Acronym / sponsor ID
- UOran1bileductinjury
- Conditions
- Bile Duct Injury
- Keywords
- bile duct injury, surgery, laparoscopy, cholecystectomy, Bile duct stricture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of Oran 1University, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 27 Feb 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 bile duct injury is a complication that occurs mainly after the cholecystectomy. Bile duct stricture is one of complications of this unwitting iatrogenic injury, the outcomes of surgery in this case are worse when the level of the stricture is above the helium.
So what are factors influencing the occurrence of this high level bile duct obstruction ?
Detailed description
The objective of this study was to answer a simple question, what are the factors influencing the occurrence of high level -called hilar biliary stricture? To answer this question, a retrospective study was carried out on the files of patients operated for biliary stenosis after operative trauma of the bile ducts in our department over a period from January 2010 to May 2018. Only patients operated in biliary stricture (Grade E Strasberg) was included.
A univariate and muntivariate logistic regression analysis was performed to determine the factors influencing the occurrence of hilar stenosis. data entry and analysis was done using SPSS V20.0 software.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hilar stricture | – | Diagnostic Test: Biliary RMI and CT scan.Bile duct Stricture (corresponding to E3, E4 and E5 from of Strasberg. -According to the classification proposed by Strasberg of operative bile duct injuries). |
| Low level Stricture | – | Diagnostic Test: Biliary RMI and CT scan.Bile duct Stricture (corresponding to E1 and E2 from Strasberg. -According to the classification proposed by Strasberg of operative bile duct injuries). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All cases of biliary structure admitted for the management of an operative bile duct injury in the hepatobiliary surgery and liver transplant department of EHU-1st November 1954 / Oran, Algeria. No geographic origin is excluded, patients are admitted in our department following a meducal consultation, a medical orientation or an emergency evacuation. Any patient meeting the inclusion criteria is eligible for this study after informed consent concerning the use of their personal data for research purposes with respect for anonymity and professional secrecy.
Key inclusion criteria (1 listed)
- all cases with biliary stricture following an operative bile duct injury.
Key exclusion criteria (2 listed)
- cases of biliary stricture following an non operative bile duct injury (Blind or penetrating abdominal trauma , radiological or endoscopic maneuvers).
- cases of biliary stricture following hepatectomy
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 |
|---|---|---|
| Biliary RMI and CT scan.For a good appreciation of the anatomy of the biliary lesion, an MRI was systematically performed on all our patients. For a good appreciation of the presence of an associated vascular lesion, a CT-scan was systematically performed on all our patients. | Diagnostic test | Hilar stricture, Low level Stricture |
Primary outcome
Factors influencing occurrence of hilar stricture (E3,E4,E5)
Time frame: from the date of the surgery that caused the biliary injury to the date of transfer to our structure for treatment. in our series, the period varies from 8 weeks to 10 years after the occurrence of operative bile duct injury during initial surgery.
all the variables related to the patient, his disease and the course of the surgical intervention which caused the biliary trauma was recorded.
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 27 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
Noureddine Benmaarouf, Pr study director
University of Oran 1
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 Duct Injury, 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 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 27 Feb 2020. 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?
Factors influencing occurrence of hilar stricture (E3,E4,E5) (time frame: from the date of the surgery that caused the biliary injury to the date of transfer to our structure for treatment. in our series, the period varies from 8 weeks to 10 years after the occurrence of operative bile duct injury during initial surgery.). 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 27 Feb 2020.