Back to resultsBile Leaks After Biliary Surgery
Primary Purpose
Bile Leak, Anastomotic Leak Biliary, Biliary Tract Fistula
Status
Unknown status
Phase
Not Applicable
Locations
Algeria
Study Type
Interventional
Intervention
bilioenteric anastomosis i
Sponsored by
About this trial
This is an interventional prevention trial for Bile Leak focused on measuring hepatobiliary surgery, Morbidity, leak, anastomosis
Eligibility Criteria
Inclusion Criteria:
- Any patient who has undergone a surgical bilioenteric anastomosis for any etiology.
Exclusion Criteria:
- Any patient who has undergone a nonsurgical (endoscopic / radiological) bilioenteric anastomosis.
- Subjects under the age of 18. Years.
- Subjects who refused to participate in this study.
- Cases of biliary and pancreatic anastomoses performed during the same surgery.
Sites / Locations
- Departmenet of hepatobiliary surgery, EHU-1st November 1954, Oran.Recruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patient in whom a bilioenteric anastomosis is performed for any etiology.
Arm Description
Patient in whom a bilioenteric anastomosis is performed for any etiology..
Outcomes
Primary Outcome Measures
The occurrence of a bile leak in the postoperative period (Day 0 to Day 90).
Occurrence of a bile leak visible through a drain, through the wound, visible on the control radiology, or after the occurrence of a peritoneal collection or biliary peritonitis.
Secondary Outcome Measures
Postoperative hospital stay
length of postoperative hospital stay
Mortality
Mortality after surgery
Full Information
NCT ID
NCT04665427
First Posted
November 29, 2020
Last Updated
December 10, 2020
Sponsor
University of Oran 1
1. Study Identification
Unique Protocol Identification Number
NCT04665427
Brief Title
Bile Leaks After Biliary Surgery
Official Title
Factors That Influence the Occurrence of Bile Leaks After Biliary Anastomosis Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 18, 2020 (Actual)
Primary Completion Date
November 18, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oran 1
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of our study is to identify the factors influencing the occurrence of a biliary leak after performing surgery leading to the creation of a biliary anastomosis to any segment of the digestive tract.
Detailed Description
The objective of our study is to identify the factors influencing the occurrence postoperative of biliary leaks, Sex, Age, BMI, Bilirubin level, Protein level, and surgical technique (And other factors)are analyzed to study their influence on occurrence of postoperative biliary leak.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bile Leak, Anastomotic Leak Biliary, Biliary Tract Fistula
Keywords
hepatobiliary surgery, Morbidity, leak, anastomosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient in whom a bilioenteric anastomosis is performed for any etiology.
Arm Type
Other
Arm Description
Patient in whom a bilioenteric anastomosis is performed for any etiology..
Intervention Type
Other
Intervention Name(s)
bilioenteric anastomosis i
Other Intervention Name(s)
hepatico duodenostomy, hepaticojejunostomy
Intervention Description
The creation of communication between a bile duct and a segment of the digestive tract, often to restore a flow of bile in the digestive tract,
Primary Outcome Measure Information:
Title
The occurrence of a bile leak in the postoperative period (Day 0 to Day 90).
Description
Occurrence of a bile leak visible through a drain, through the wound, visible on the control radiology, or after the occurrence of a peritoneal collection or biliary peritonitis.
Time Frame
From (day 0) of surgery to (day 90)
Secondary Outcome Measure Information:
Title
Postoperative hospital stay
Description
length of postoperative hospital stay
Time Frame
From (day 0) of surgery to (day 90)
Title
Mortality
Description
Mortality after surgery
Time Frame
From day 0 to day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any patient who has undergone a surgical bilioenteric anastomosis for any etiology.
Exclusion Criteria:
Any patient who has undergone a nonsurgical (endoscopic / radiological) bilioenteric anastomosis.
Subjects under the age of 18. Years.
Subjects who refused to participate in this study.
Cases of biliary and pancreatic anastomoses performed during the same surgery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anisse Tidjane, Dr
Phone
0561806152
Email
tidjane.anisse@univ-oran1.dz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benali Tabeti, Pr
Organizational Affiliation
University Oran1
Official's Role
Study Chair
Facility Information:
Facility Name
Departmenet of hepatobiliary surgery, EHU-1st November 1954, Oran.
City
Oran
ZIP/Postal Code
31000
Country
Algeria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anisse Tidjane, MCA
Phone
00213561806152
Email
tidjane.anisse@univ-oran1.dz
First Name & Middle Initial & Last Name & Degree
Amel Laredj, Dr
Email
ameldj81@yahoo.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Bile Leaks After Biliary Surgery
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