Biliary Strictur After Hepatojejunostomy (HJ)NCT01447030
Long Time Follow up After HJ Following Iatrogenic Bile Duct Injuries
An observational study of Biliary Strictur After Hepatojejunostomy (HJ) and Morbidity and Mortality After and Around HJ, run by Odense University Hospital.
Trial summary
Introduction: Bile duct injury (BDI) after cholecystectomy remains a serious complication with major implications for patient outcome. For most major BDIs, the recommended method of repair is a hepaticojejunostomy (HJ). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Biliary Strictur After Hepatojejunostomy (HJ), Morbidity and Mortality After and Around HJ
- How many people
- 139 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Oct 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with iatrogenic bile duct injury (BDI) after cholecystectomy reconstructed with hepatojejunostomia. Collecting data from 5 Danish tertiary hepato-biliary centres from january 1995 to may 2009.
Who may be able to join
- All patients with iatrogenic Bile duct injury (BDI) after cholecystectomy reconstructed with hepatojejunostomy/choledochojejunostomy.
Who cannot join
- Patients with non-cholecystectomy-related BDI or with cholecystectomy-related BDI that had been definitively managed by other techniques.
About this study
Official title: Langtidsopfølgning Efter Kirurgisk Behandling af Iatrogene galdevejslæsioner opstået i Forbindelse Med Cholecystektomi
Introduction: Bile duct injury (BDI) after cholecystectomy remains a serious complication with major implications for patient outcome. For most major BDIs, the recommended method of repair is a hepaticojejunostomy (HJ). We conducted a retrospective review from 5 Danish hepatobiliary centres aiming to examine the perioperative and the long-term outcome after reconstructive HJ.
- Conditions
- Biliary Strictur After Hepatojejunostomy (HJ), Morbidity and Mortality After and Around HJ
- Keywords
- Biliary strictur, Hepatojejunostomy, Iatrogenic major bile duct injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Stricture of HJ
Stricture of hepaticojejunostomy after reconstruction
Measured: days to years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Strictur After Hepatojejunostomy (HJ)Studies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University Hospital, Aarhus University Hospital, Herlev Hospital, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Nicolaj Markus Stilling, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447030
- Sponsor's protocol ID
- NMS1
- Status last verified
- Mar 2020
- First submitted
- 2 Oct 2011
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Langtidsopfølgning Efter Kirurgisk Behandling af Iatrogene galdevejslæsioner opstået i Forbindelse Med Cholecystektomi
- ClinicalTrials.gov ID
- NCT01447030
- Acronym / sponsor ID
- NMS1
- Conditions
- Biliary Strictur After Hepatojejunostomy (HJ), Morbidity and Mortality After and Around HJ
- Keywords
- Biliary strictur, Hepatojejunostomy, Iatrogenic major bile duct injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Aalborg University Hospital, Aarhus University Hospital, Herlev Hospital, Copenhagen University Hospital, Rigshospitalet
- Study start
- Oct 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 5 Oct 2011 (estimated)
- 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.
Introduction: Bile duct injury (BDI) after cholecystectomy remains a serious complication with major implications for patient outcome. For most major BDIs, the recommended method of repair is a hepaticojejunostomy (HJ). We conducted a retrospective review from 5 Danish hepatobiliary centres aiming to examine the perioperative and the long-term outcome after reconstructive HJ.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with iatrogenic bile duct injury (BDI) after cholecystectomy reconstructed with hepatojejunostomia. Collecting data from 5 Danish tertiary hepato-biliary centres from january 1995 to may 2009.
Key inclusion criteria (1 listed)
- All patients with iatrogenic Bile duct injury (BDI) after cholecystectomy reconstructed with hepatojejunostomy/choledochojejunostomy.
Key exclusion criteria (1 listed)
- Patients with non-cholecystectomy-related BDI or with cholecystectomy-related BDI that had been definitively managed by other techniques.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stricture of HJ
Time frame: days to years
Stricture of hepaticojejunostomy after reconstruction
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 9 Mar 2020.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Strictur After Hepatojejunostomy (HJ) and Morbidity and Mortality After and Around HJ, run by Odense University Hospital.
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 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Stricture of HJ (time frame: days to years). 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 9 Mar 2020.