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

February 24, 2020 updated by: Anisse Tidjane, University of Oran 1

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 ?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Algeria
      • Oran, Algeria, 31000
        • Tidjane Anisse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oran 1

Investigators

  • Study Director: Noureddine Benmaarouf, Pr, University of Oran 1

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

February 20, 2020

First Submitted That Met QC Criteria

February 24, 2020

First Posted (Actual)

February 27, 2020

Study Record Updates

Last Update Posted (Actual)

February 27, 2020

Last Update Submitted That Met QC Criteria

February 24, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UOran1bileductinjury

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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