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

Bile Duct Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04286763
• Other study ID #: UOran1bileductinjury
• Status: Completed
• Start date: January 1, 2010
• Est. completion date: September 30, 2018

Study information

• Verified date: February 2020
• Source: University of Oran 1
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: September 30, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bile Duct Injury
• Constriction, Pathologic
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Algeria	Tidjane Anisse	Oran

Sponsors (1)

Lead Sponsor	Collaborator
University of Oran 1

Country where clinical trial is conducted

Algeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.