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Factors Influencing Occurrence Of Hilar Biliary Stricture In Case of Bile Duct Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04286763
Recruitment Status : Completed
First Posted : February 27, 2020
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
Anisse Tidjane, University of Oran 1

Brief 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.

So what are factors influencing the occurrence of this high level bile duct obstruction ?


Condition or disease Intervention/treatment
Bile Duct Injury Diagnostic Test: Biliary RMI and CT scan.

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.

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Study Type : Observational
Actual Enrollment : 53 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Factors Influencing Occurence Of Hight Level of Biliary Stricture Due to Operative Bile Duct Injury
Actual Study Start Date : January 1, 2010
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : September 30, 2018

Group/Cohort Intervention/treatment
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).
Diagnostic Test: 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.


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).
Diagnostic Test: 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.





Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • all cases with biliary stricture following an operative bile duct injury.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04286763


Locations
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Algeria
Tidjane Anisse
Oran, Algeria, 31000
Sponsors and Collaborators
University of Oran 1
Investigators
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Study Director: Noureddine Benmaarouf, Pr University of Oran 1
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Responsible Party: Anisse Tidjane, Ph.D, University of Oran 1
ClinicalTrials.gov Identifier: NCT04286763    
Other Study ID Numbers: UOran1bileductinjury
First Posted: February 27, 2020    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anisse Tidjane, University of Oran 1:
bile duct injury
surgery
laparoscopy
cholecystectomy
Bile duct stricture
Additional relevant MeSH terms:
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Constriction, Pathologic
Wounds and Injuries
Pathological Conditions, Anatomical