Liver TransplantationPhase 4NCT00646685
Duct-to-duct vs Roux-en-y Hepaticojejunostomy for Biliary Reconstruction in Adult Living Donor Liver Transplantation
A Phase 4 study testing surgical technique: duct-to-duct biliary reconstruction and surgical technique: roux-en-y biliary reconstruction in people with Liver Transplantation, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to empirically determine whether one of 2 surgical techniques commonly used for bile duct reconstruction during living donor liver transplantation results in fewer biliary complications. Also, this study may identify patient group(s) that particularly benefit from a particular technique. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- surgical technique: duct-to-duct biliary reconstruction and surgical technique: roux-en-y biliary reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2008to Jul 2016
- Phase
- Phase 4
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient with end-stage liver disease
- living donor liver transplantation using right hemi-liver as graft
- duct anastomosis possible at time of surgery
- donor and recipient aged 18 yrs or older
- written informed consent obtained
Who cannot join
- duct anastomosis not possible
- acute fulminant liver failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Trial for Comparison of Duct-to-duct and Roux-en-y Hepaticojejunostomy for Biliary Reconstruction in Adult Living Donor Liver Transplantation
The purpose of this study is to empirically determine whether one of 2 surgical techniques commonly used for bile duct reconstruction during living donor liver transplantation results in fewer biliary complications. Also, this study may identify patient group(s) that particularly benefit from a particular technique.
Read the detailed description
The purpose of this study is to compare the incidence of biliary complications (bile leaks and strictures) following duct-to-duct and roux-en-y biliary reconstruction during right lobe living donor liver transplantation.
Biliary complications are much more common with right lobe living donor liver grafts than with whole organ grafts and are considered a major limitation of this surgery. Two surgical techniques are currently used for biliary reconstruction and each has its advantages/disadvantages. However, it is unclear which technique leads to fewer biliary complications. Retrospective studies which examine biliary complication rates may be hampered by such factors as a surgeon's bias or inexperience with a particular technique. Therefore a prospective randomized trial is needed.
- Conditions
- Liver Transplantation
- Being tested
- surgical technique: duct-to-duct biliary reconstruction, surgical technique: roux-en-y biliary reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical technique: duct-to-duct biliary reconstructionProcedure or surgery
surgical reconstruction
surgical technique: roux-en-y biliary reconstructionProcedure or surgery
surgical reconstruction
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Procedure: surgical technique: duct-to-duct biliary reconstruction |
| 2 | Other | Not described Receives: Procedure: surgical technique: roux-en-y biliary reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biliary complications defined as leaks and strictures within the first year post LDLT;
Measured: 1 year
Secondary outcomes (4)
Graft and patient survival
Measured: 1 year post-transplant
Length of hospital-stay and ICU-stay
Measured: within first 30 days after discharge
Any infection or rejection episodes
Measured: 1 year post- transplant
time to full oral nutrition
Measured: within 30 days of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionJul 2015 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus Selzner, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646685
- Sponsor's protocol ID
- 07-0498-B
- Status last verified
- Jun 2012
- First submitted
- 25 Mar 2008
- Last updated
- 25 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial for Comparison of Duct-to-duct and Roux-en-y Hepaticojejunostomy for Biliary Reconstruction in Adult Living Donor Liver Transplantation
- ClinicalTrials.gov ID
- NCT00646685
- Acronym / sponsor ID
- 07-0498-B
- Conditions
- Liver Transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 28 Mar 2008 (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.
The purpose of this study is to empirically determine whether one of 2 surgical techniques commonly used for bile duct reconstruction during living donor liver transplantation results in fewer biliary complications. Also, this study may identify patient group(s) that particularly benefit from a particular technique.
Detailed description
The purpose of this study is to compare the incidence of biliary complications (bile leaks and strictures) following duct-to-duct and roux-en-y biliary reconstruction during right lobe living donor liver transplantation.
Biliary complications are much more common with right lobe living donor liver grafts than with whole organ grafts and are considered a major limitation of this surgery. Two surgical techniques are currently used for biliary reconstruction and each has its advantages/disadvantages. However, it is unclear which technique leads to fewer biliary complications. Retrospective studies which examine biliary complication rates may be hampered by such factors as a surgeon's bias or inexperience with a particular technique. Therefore a prospective randomized trial is needed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: surgical technique: duct-to-duct biliary reconstruction |
| 2 | Other | Procedure: surgical technique: roux-en-y biliary reconstruction |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patient with end-stage liver disease
- living donor liver transplantation using right hemi-liver as graft
- duct anastomosis possible at time of surgery
- donor and recipient aged 18 yrs or older
- written informed consent obtained
Key exclusion criteria (2 listed)
- duct anastomosis not possible
- acute fulminant liver failure
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 |
|---|---|---|
| surgical technique: duct-to-duct biliary reconstructionsurgical reconstruction | Procedure or surgery | 1 |
| surgical technique: roux-en-y biliary reconstructionsurgical reconstruction | Procedure or surgery | 2 |
Primary outcome
Biliary complications defined as leaks and strictures within the first year post LDLT;
Time frame: 1 year
4 secondary outcomes
Graft and patient survival
Time frame: 1 year post-transplant
Length of hospital-stay and ICU-stay
Time frame: within first 30 days after discharge
Any infection or rejection episodes
Time frame: 1 year post- transplant
time to full oral nutrition
Time frame: within 30 days of discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2014.
Related trials for Liver Transplantation
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingPhase 2
Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
Liver Transplant
RecruitingObservational study
Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
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.
Markus Selzner, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing surgical technique: duct-to-duct biliary reconstruction and surgical technique: roux-en-y biliary reconstruction in people with Liver Transplantation, run by University Health Network, Toronto at 1 site in Canada.
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 5 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: status not confirmed, as of the sponsor's last update on 25 Jul 2014. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Biliary complications defined as leaks and strictures within the first year post LDLT; (time frame: 1 year). 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 25 Jul 2014.