Clinical trial NCT04286763: Factors Influencing Occurrence Of Hilar Biliary Stricture In Case of Bile Duct Injury
Official title: Factors Influencing Occurence Of Hight Level of Biliary Stricture Due to Operative Bile Duct Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bile Duct Injury
Keywords: bile duct injury
surgery
laparoscopy
cholecystectomy
Bile duct stricture
Lead sponsor: University of Oran 1
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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 ?

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.

Eligibility 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

Primary outcomes:
measure: Factors influencing occurrence of hilar stricture (E3,E4,E5)
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Oran
country: Algeria
facility: Tidjane Anisse
Study officials:
affiliation: University of Oran 1
name: Noureddine Benmaarouf, Pr
role: STUDY_DIRECTOR
References: