Bile Leaks After Biliary Surgery

Bile Leak Clinical Trial

Official title:

Factors That Influence the Occurrence of Bile Leaks After Biliary Anastomosis Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04665427
• Other study ID #: UOran1_surgery_Bile_leak
• Status: Recruiting
• Phase: N/A
• Start date: November 18, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2020
• Source: University of Oran 1
• Contact: Anisse Tidjane, Dr
• Phone: 0561806152
• Email: tidjane.anisse[@]univ-oran1.dz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2021
• Est. primary completion date: November 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anastomotic Leak
• Anastomotic Leak Biliary
• Bile Leak
• Biliary Fistula
• Biliary Tract Fistula
• Fistula

Intervention

Other:
• bilioenteric anastomosis i
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,

Locations

Country	Name	City	State
Algeria	Departmenet of hepatobiliary surgery, EHU-1st November 1954, Oran.	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	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.	From (day 0) of surgery to (day 90)
Secondary	Postoperative hospital stay	length of postoperative hospital stay	From (day 0) of surgery to (day 90)
Secondary	Mortality	Mortality after surgery	From day 0 to day 90