Liver FailureNCT06767553
Biliary Complication Rates in Living Donor Liver Transplantation: a Retrospective Comparative Study of Stent Versus Non-Stent Groups
An observational study of Liver Failure and Living Donor Liver Transplantation, run by Chungnam National University Hospital at 1 site in South Korea.
Trial summary
Despite technological advancements in living donor liver transplantation (LDLT), biliary complications (BC), including biliary anastomotic stricture (BAS) and bile leak (BL), remain unresolved issues that significantly affect patient outcomes. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Liver Failure, Living Donor Liver Transplantation, Biliary Complications
- How many people
- 160 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2011to 30 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study includes adult patients aged 19 to 80 years who underwent liver transplantation for liver disease at Chungnam National University Hospital. The study population consists of patients who received either biliary stent placement or no stent placement during the liver transplantation surgery. Data will be retrospectively reviewed to compare biliary complications between the two groups.
Who may be able to join
- Adults aged between 19 and 80 years at the time of liver transplantation.
- Patients who underwent liver transplantation surgery for liver disease performed by the Department of Surgery at Chungnam National University Hospital under the supervision of the principal investigator.
- Patients who signed the informed consent form before study registration (for future participants).
Who cannot join
- Patients who have not signed the informed consent form or have insufficient understanding of the clinical trial protocol, making it difficult to accurately express their intention to participate.
- Patients deemed unsuitable for participation in this clinical study by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Non-stenting Method with Mucosal Eversion on Biliary Complications Post-LDLT in a Mid-volume Center: a Propensity Score-Matching Analysis of Case-Control Study
Despite technological advancements in living donor liver transplantation (LDLT), biliary complications (BC), including biliary anastomotic stricture (BAS) and bile leak (BL), remain unresolved issues that significantly affect patient outcomes. Biliary stenting has emerged as a potential method for reducing BC in LDLT procedures; however, their necessity remains debated. This study aimed to assess the necessity of biliary stenting by retrospectively comparing the bile duct complication rates in LDLT using duct-to-duct anastomosis with or without biliary stenting.
- Medical subject headings
- Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stented | Patients who received biliary stent placement during liver transplantation. | |
| Non-stented | Patients who did not receive biliary stent placement during liver transplantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Biliary Complications
The primary outcome measure is the incidence of biliary complications, including bile leaks and biliary anastomotic strictures, within 10 years post-liver transplantation. Measurment is done by electronic medical record review of post-operative imaging and clinical diagnosis during follow up period.
Measured: Within 10 years after liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start1 Nov 2011
- Primary completion31 Oct 2024
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FailureStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chungnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767553
- Sponsor's protocol ID
- 2023-11-063
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will not be shared publicly due to the retrospective nature of the study and privacy protection concerns.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Non-stenting Method with Mucosal Eversion on Biliary Complications Post-LDLT in a Mid-volume Center: a Propensity Score-Matching Analysis of Case-Control Study
- ClinicalTrials.gov ID
- NCT06767553
- Acronym / sponsor ID
- 2023-11-063
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Chungnam National University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2011 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 10 Jan 2025 (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.
Despite technological advancements in living donor liver transplantation (LDLT), biliary complications (BC), including biliary anastomotic stricture (BAS) and bile leak (BL), remain unresolved issues that significantly affect patient outcomes. Biliary stenting has emerged as a potential method for reducing BC in LDLT procedures; however, their necessity remains debated. This study aimed to assess the necessity of biliary stenting by retrospectively comparing the bile duct complication rates in LDLT using duct-to-duct anastomosis with or without biliary stenting.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stented | – | –Patients who received biliary stent placement during liver transplantation. |
| Non-stented | – | –Patients who did not receive biliary stent placement during liver transplantation. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes adult patients aged 19 to 80 years who underwent liver transplantation for liver disease at Chungnam National University Hospital. The study population consists of patients who received either biliary stent placement or no stent placement during the liver transplantation surgery. Data will be retrospectively reviewed to compare biliary complications between the two groups.
Key inclusion criteria (3 listed)
- Adults aged between 19 and 80 years at the time of liver transplantation.
- Patients who underwent liver transplantation surgery for liver disease performed by the Department of Surgery at Chungnam National University Hospital under the supervision of the principal investigator.
- Patients who signed the informed consent form before study registration (for future participants).
Key exclusion criteria (2 listed)
- Patients who have not signed the informed consent form or have insufficient understanding of the clinical trial protocol, making it difficult to accurately express their intention to participate.
- Patients deemed unsuitable for participation in this clinical study by the investigator.
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
Incidence of Biliary Complications
Time frame: Within 10 years after liver transplantation
The primary outcome measure is the incidence of biliary complications, including bile leaks and biliary anastomotic strictures, within 10 years post-liver transplantation. Measurment is done by electronic medical record review of post-operative imaging and clinical diagnosis during follow up period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Individual participant dataSharing planned: No. The data will not be shared publicly due to the retrospective nature of the study and privacy protection concerns.
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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.
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 Liver Failure and Living Donor Liver Transplantation, run by Chungnam National University Hospital at 1 site in South Korea.
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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 10 Jan 2025. 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
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 Biliary Complications (time frame: Within 10 years after liver transplantation). 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 10 Jan 2025.