Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05479227
Other study ID # AR
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2019
Est. completion date June 5, 2022

Study information

Verified date July 2022
Source North Estonia Medical Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this retrospective study is to review the annual incidence, management, and outcomes of bile duct injuries (BDI) during laparoscopic cholecystectomy (LC) in a population-based cohort during 2008-2018 in Estonia.


Description:

The aim of this retrospective study is to review the annual incidence, management, and outcomes of bile duct injuries (BDI) during laparoscopic cholecystectomy (LC) in a population-based cohort during 2008-2018 in Estonia. Background Data: Iatrogenic bile duct injuries (BDI) following laparoscopic cholecystectomy (LC) result in major morbidity and incidental mortality. There is a lack of unselected population-based cross-sectional studies on the incidence, management, and outcomes of BDI. We hypothesised that due to improved imaging capabilities and collective laparoscopic experience, the BDI incidence will decrease over the study period and compare favourably with contemporary literature. After IRB approval, all cholecystectomies performed at national public healthcare facilities between 2008 and 2018 were retrospectively reviewed. BDIs were classified according to the Strasberg classification. We hypothesized that due to improved imaging capabilities and collective laparoscopic experience the BDI incidence will decrease over the study period and compare favourably to contemporary literature.


Recruitment information / eligibility

Status Completed
Enrollment 241
Est. completion date June 5, 2022
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - all patients with BDI during laparoscopic cholecystectomy (LC) Exclusion Criteria: - The sole exclusion criterion in the case selection was cholecystectomy performed primarily using the open method

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Management of bile duct injury
There are different options for BDI management, we analyzed their utilization and results

Locations

Country Name City State
Estonia Arvo Reinsoo Tallin

Sponsors (2)

Lead Sponsor Collaborator
North Estonia Medical Centre University of Tartu

Country where clinical trial is conducted

Estonia, 

Outcome

Type Measure Description Time frame Safety issue
Primary incidence of bile duct injuries We aimed to review the annual incidence of bile duct injuries in a population-based cohort in Estonia. During the years 2008-2018
See also
  Status Clinical Trial Phase
Recruiting NCT05169073 - Virtual Reality Training for Laparoscopic Cholecystectomy N/A
Recruiting NCT05709548 - Use of Indocyanine Green in Acute Cholecystitis Phase 4
Completed NCT03673033 - Biliary Complications in Live Donor Liver Transplantation
Not yet recruiting NCT05243225 - Laparoscopic Versus Open Surgical Management of Post Cholecystectomy Bile Duct Injury
Active, not recruiting NCT06223061 - Global Evaluation of Cholecystectomy Knowledge and Outcomes
Recruiting NCT03716232 - Kaffes Stent in the Management of Post-surgical Biliary Strictures Phase 3
Recruiting NCT02801500 - Superior Bilioenteric Anastomosis by Magnetic Compressive Technique N/A
Recruiting NCT04908826 - Comparison of Icg's Route of Administration During Laparoscopic Cholecystectomy N/A
Recruiting NCT03386201 - FLuorescence Cholangiography Using Methylene Blue N/A
Completed NCT04286763 - Factors Influencing Occurrence Of Hilar Biliary Stricture In Case of Bile Duct Injury
Completed NCT04582240 - Bile Duct Injury Digestif
Recruiting NCT03774589 - Bilioenteric Anastomosis by Magnetic Compressive Technique N/A
Completed NCT05556668 - Percutaneous Biodegradable Biliary Stents for the Treatment of Benign Biliary Strictures.