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

NCT04286763 | Completed

• 1 other identifier: UOran1bileductinjury
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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 ?

Conditions

Bile Duct Injury

Keywords

bile duct injury; surgery; laparoscopy; cholecystectomy; Bile duct stricture

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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.

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.

Interventions

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.

Hilar stricture; Low level Stricture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• all cases with biliary stricture following an operative bile duct injury.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oran 1: lead

Study Sites (1)

Tidjane Anisse

Oran, 31000, Algeria

Location

MeSH Terms

Interventions

Tomography, X-Ray Computed

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Noureddine Benmaarouf, Pr

  University of Oran 1

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: February 27, 2020
• Study Start: January 1, 2010
• Primary Completion: May 1, 2018
• Study Completion: September 30, 2018
• Last Updated: February 27, 2020

Record last verified: 2020-02

Locations

AL (1)