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Completed

NCT Number: NCT04286763

Factors Influencing Occurrence Of Hilar Biliary Stricture In Case of 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 ?

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tidjane Anisse

Oran, 31000, Algeria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Oran 1

Other

Registry information

Official study title

Factors Influencing Occurence Of Hight Level of Biliary Stricture Due to Operative Bile Duct Injury

Important dates

Study start
2010
Primary completion
2018
Study completion
2018
First posted
Feb 27, 2020
Registry last updated
Feb 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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