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CompletedNCT04665427Updated Jun 25, 2024

Factors Influencing Occurrence of Bile Leaks in Surgery

An interventional study of bilioenteric anastomosis i in Bile Leak, Anastomotic Leak Biliary and Biliary Tract Fistula, sponsored by University of Oran 1. Completed at 1 site in Algeria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-25.

Sponsored by University of Oran 1 · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bile Leak
  • Anastomotic Leak Biliary
  • Biliary Tract Fistula

Keywords

  • hepatobiliary surgery
  • Morbidity
  • leak
  • anastomosis
03

In context

Lead sponsor

University of Oran 1 is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Any patient who has undergone a surgical bilioenteric anastomosis for any etiology.

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
108 participants (actual)

Study arms

  • Other
    Patient in whom a bilioenteric anastomosis is performed for any etiology.

    Patient in whom a bilioenteric anastomosis is performed for any etiology..

    Other: bilioenteric anastomosis i

Interventions

  • Otherbilioenteric 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,

    Also known as: hepatico duodenostomy, hepaticojejunostomy

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From (day 0) of surgery to (day 90)

Secondary outcomes

  1. Postoperative hospital stay

    length of postoperative hospital stay

    Time frame: From (day 0) of surgery to (day 90)

  2. Mortality

    Mortality after surgery

    Time frame: From day 0 to day 90

07

Study locations

1 site
  • Departmenet of hepatobiliary surgery, EHU-1st November 1954, Oran.
    Oran, 31000, Algeria
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2020 to primary completion in Jul 2022, 20 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 29, 2020
First posted
Dec 11, 2020
StartActual
Nov 18, 2020
Primary completionActual
Jul 18, 2022
CompletionActual
Aug 1, 2022
Last update
Jun 25, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04665427
Lead sponsor
University of Oran 1
Responsible party
Anisse Tidjane (Associate Professor, University of Oran 1) — Principal investigator
First posted
Dec 11, 2020
Start date
Nov 18, 2020
Primary completion
Jul 18, 2022
Completion
Aug 1, 2022
Last update
Jun 25, 2024

Study contacts

Benali Tabeti, Pr
study chair · University Oran1

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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