Bile Duct InjuryNCT05479227
Bile Duct Injuries During Laparoscopic Cholecystectomies: An 11-year Population-based Study
An observational study of Bile Duct Injury, run by North Estonia Medical Centre at 1 site in Estonia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bile Duct Injury
- What is being tested?
- Management of bile duct injury
- Type of treatment
- Surgery or procedure
- How many people
- 241 participants
- Where
- 1 siteEstonia
- Study dates
- 1 Jun 2019to 5 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population consists of patients who experienced a bile duct injury during laparoscopic cholecystectomy during 2008-2018 in Estonian national health care facilities. The data was obtained according to coding in National Health Insurance Fund electronic database. Data on readmissions related to BDIs and their subsequent complications were collected from the National Institute for Health Development repository.
Who may be able to join
- all patients with BDI during laparoscopic cholecystectomy (LC)
Who cannot join
- The sole exclusion criterion in the case selection was cholecystectomy performed primarily using the open method
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Bile Duct Injury
- Being tested
- Management of bile duct injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Management of bile duct injuryProcedure or surgery
There are different options for BDI management, we analyzed their utilization and results
| Study group | Role | What they receive |
|---|---|---|
| Patients with bile duct injuries during laparoscopic cholecystectomy | The data concerning 241 patients´ BDI emergence, severity, management, and outcomes was analyzed Receives: Procedure: Management of bile duct injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of bile duct injuries
We aimed to review the annual incidence of bile duct injuries in a population-based cohort in Estonia.
Measured: During the years 2008-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start1 Jun 2019
- Primary completion1 Jun 2021
- Study completion5 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile Duct InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Estonia Medical Centre
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tartu
- Responsible party
- Principal investigator, Arvo Reinsoo, North Estonia Medical Centre
- Investigators
- Arvo Reinsoo, MD, Principal investigator, North Estonia Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479227
- Sponsor's protocol ID
- AR
- Status last verified
- Jul 2022
- First submitted
- 26 Jul 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bile Duct Injuries During Laparoscopic Cholecystectomies: An 11-year Population-based Study
- ClinicalTrials.gov ID
- NCT05479227
- Acronym / sponsor ID
- AR
- Conditions
- Bile Duct Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- North Estonia Medical CentreUniversity, hospital or other
- Collaborators
- University of Tartu
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 5 Jun 2022 (actual)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with bile duct injuries during laparoscopic cholecystectomy | – | Procedure: Management of bile duct injuryThe data concerning 241 patients´ BDI emergence, severity, management, and outcomes was analyzed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population consists of patients who experienced a bile duct injury during laparoscopic cholecystectomy during 2008-2018 in Estonian national health care facilities. The data was obtained according to coding in National Health Insurance Fund electronic database. Data on readmissions related to BDIs and their subsequent complications were collected from the National Institute for Health Development repository.
Key inclusion criteria (1 listed)
- all patients with BDI during laparoscopic cholecystectomy (LC)
Key exclusion criteria (1 listed)
- The sole exclusion criterion in the case selection was cholecystectomy performed primarily using the open method
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Management of bile duct injuryThere are different options for BDI management, we analyzed their utilization and results | Procedure or surgery | Patients with bile duct injuries during laparoscopic cholecystectomy |
Primary outcome
incidence of bile duct injuries
Time frame: During the years 2008-2018
We aimed to review the annual incidence of bile duct injuries in a population-based cohort in Estonia.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Individual participant dataSharing planned: Undecided
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Recruiting
Virtual Reality Training for Laparoscopic Cholecystectomy
Virtual Reality, Gallbladder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arvo Reinsoo, MD principal investigator
North Estonia Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bile Duct Injury, run by North Estonia Medical Centre at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of bile duct injuries (time frame: During the years 2008-2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022; AzTrials last refreshed its copy on 7 Nov 2026.