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

Sponsor

University of Oran 1 (Other)

Overall Status

Completed

CT.gov ID

NCT04286763

Collaborator

(none)

Enrollment

Location

104.9

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

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 :

Jan 1, 2010

Actual Primary Completion Date :

May 1, 2018

Actual Study Completion Date :

Sep 30, 2018

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Factors influencing occurrence of hilar stricture (E3,E4,E5) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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