Aortohepatic ConduitNCT03275883
Arterial Patency in Liver Transplantation
An observational study of Aortohepatic Conduit and Patency Rate, run by University of Zurich at 1 site in Switzerland.
Trial summary
The aim of this study is to determine the risk profile of hepatic artery occlusion in liver transplant recipients who received an aortohepatic conduits, analyzing all consecutive cadaveric liver transplantations from July 2007 to 31st December 2016. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortohepatic Conduit, Patency Rate, Liver Transplantation
- What is being tested?
- Aortohepatic Conduit
- Type of treatment
- Surgery or procedure
- How many people
- 567 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2017to 1 Dec 2019
- How long will I take part?
- 1 Year
- 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: Patients who recieved an aorto-hepatic conduit during liver transplantation
Who may be able to join
- Liver transplantation requiring aorto-hepatic or iliac-hepatic conduits
- Deceased donor after brain death (DBD) or deceased donor after circulatory death (DCD)
- Whole organ as well as split allografts
- Primary liver transplantation as well as liver retransplantation
- Recipient age ≥18 years
Who cannot join
- Living donor liver transplantation
- Pediatric liver transplantation (recipient age <18 years)
- Arterial reconstruction other than aorto-hepatic or iliac-hepatic conduits
- Multivisceral transplantations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Analysis to Identify Independent Predictive Risk Factors for Early and Late Arterial Occlusion in Liver Transplantation and Compare Short and Long-term Outcomes for Aorto-hepatic Conduits in Liver Transplantation
The aim of this study is to determine the risk profile of hepatic artery occlusion in liver transplant recipients who received an aortohepatic conduits, analyzing all consecutive cadaveric liver transplantations from July 2007 to 31st December 2016. Medical records will be examined and adverse events will be analyzed and categorized using the Clavien-Dindo classification and Comprehensive Complication Index.
Read the detailed description
BACKGROUND
Arterial conduits in liver transplantation are almost as old as the procedure itself. First described by Starzl in 1984, the knowledge remains superficial. Although rarely performed, there is no doubt that thousands of patients' lives were saved because of the use of arterial grafts. However, arterial grafts are known to be associated with a higher rate of occlusion and a lower patient and graft survival when compared to conventional end-to-end anastomosis. In our recent retrospective study, the investigators showed that retransplantation procedure and aspirin in patients' medication are independent risk factors for the need of an arterial conduit. The investigators assume that aspirin could be a surrogate marker for vascular and metabolic status. Furthermore, in a meta-analysis the investigators found a four times higher occlusion rate compared to non-conduits.
Whether the site of conduit placement or certain types of material have an impact on occlusion and graft survival remains unknown. In addition, several studies discuss that antiaggregation or anticoagulation might be protective for occlusion of arterial conduits. Currently, there is no study that investigated this problem, most probably because of low case numbers.
STUDY OBJECTIVES
The primary goal of this study is to conduct a multicenter cohort analysis to define the outcome of different types of conduits and to investigate whether antiplatelet / anticoagulantion has an impact on patency rates.
- Specific aim #1: To identify independent risk factors for early and late occlusion of arterial conduits in liver transplantation.
- Specific aim #2: To compare different placement sites (infrarenal, supraceliac, iliacal, etc.) of arterial conduits in terms of occlusion rates and graft survival.
- Specific aim #3: To investigate whether antiplatelet therapy is protective in terms of arterial patency.
STUDY DESIGN
This will be a multicenter single cohort study including only cases of deceased donor liver transplantation that required an aorto-hepatic or iliac-hepatic conduit for arterial reconstruction. Primary endpoint is 30-day conduit patency. Secondary endpoints include postoperative complications, death, late conduit occlusion, graft and patient survival.
SETTING
This multicenter cohort study will include several high-volume centers worldwide. Each participating center requires a prospective database from that data can be extracted. All consecutive cases of deceased donor liver transplantation requiring an arterial conduit from 1st of January 2007 until 31st of December 2016 are included allowing a minimum follow-up time of 6 months. Data collection at conduit4olt.org will be prospective, structured, anonymized, and encrypted.
INSTITUTIONAL REVIEW POLICY / ETHICAL POLICY
Each participating center is responsible to contact their local ethics committee and receive approval for participation, if applicable. For example, this project is considered as an audit in some countries and thus there is no need for formal approval in the form of a protocol submission.
ELIGIBILITY CRITERIA
Inclusion criteria:
- Liver transplantation requiring aorto-hepatic or iliac-hepatic conduits
- Deceased donor after brain death (DBD) or deceased donor after circulatory death (DCD)
- Whole organ as well as split allografts
- Primary liver transplantation as well as liver retransplantation
- Recipient age ≥18 years
Exclusion criteria:
- Living donor liver transplantation
- Pediatric liver transplantation (recipient age <18 years)
- Arterial reconstruction other than aorto-hepatic or iliac-hepatic conduits
- Multivisceral transplantations
ESTIMATED SAMPLE SIZE
Each center should provide at least 30 cases that meet the inclusion criteria to allow adequate event rates for each outcome.
Statistical methods
The primary and secondary endpoints will be compared with patient and operation characteristics with univariate analysis. ROC Curve analysis will be performed to dichotomize continuous variables. Multivariable analysis (binary logistic and Cox regression) will be performed to identify independent risk factors. Statistical analysis will be performed using R Studio version 1.0.44 (RStudio, Inc. GNU Affero General Public License v3, Boston, MA, 2016) with the graphical user interface rBiostatistics.com beta version (rBiostatistics.com, Zurich, Switzerland, 2016, GNU License).
Christian E. Oberkofler Tim Reese Dimitri A. Raptis Henrik Petrowsky
On behalf of the conduit4olt.org team Swiss HPB Center, Department of Surgery and Transplantation, University Hospital Zurich, Switzerland
- Conditions
- Aortohepatic Conduit, Patency Rate, Liver Transplantation
- Being tested
- Aortohepatic Conduit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortohepatic ConduitProcedure or surgery
Placement of an interposition graft between hepatic artery and aorta during liver transplantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Independent risk factors
To identify independent risk factors for early and late occlusion of arterial conduits in liver transplantation.
Measured: June 2007 til 31st December 2016
Placement sites
To compare different placement sites (infrarenal, supraceliac, iliacal, etc.) of arterial conduits in terms of occlusion rates and graft survival
Measured: June 2007 til 31st December 2016
Patency Rates
To investigate whether antiplatelet therapy is protective in terms of arterial patency.
Measured: June 2007 til 31st December 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start1 Sep 2017
- Primary completion5 Sep 2018
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortohepatic ConduitStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Cohort
- Time perspective
- Other
- Enrolment
- 567 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Birmingham NHS Foundation Trust, Medical University Innsbruck, University of Bologna, The Leeds Teaching Hospitals NHS Trust, University of California, Los Angeles, Johannes Gutenberg University Mainz, Rennes University Hospital, University of Lyon, University of Rochester, University of Southern California
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275883
- Sponsor's protocol ID
- 2016-01889
- Other IDs
- 2016
- Status last verified
- Mar 2020
- First submitted
- 5 Sep 2017
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis to Identify Independent Predictive Risk Factors for Early and Late Arterial Occlusion in Liver Transplantation and Compare Short and Long-term Outcomes for Aorto-hepatic Conduits in Liver Transplantation
- ClinicalTrials.gov ID
- NCT03275883
- Acronym / sponsor ID
- 2016-01889
- Conditions
- Aortohepatic Conduit, Patency Rate, Liver Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 567 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- University Hospital Birmingham NHS Foundation Trust, Medical University Innsbruck, University of Bologna, The Leeds Teaching Hospitals NHS Trust, University of California, Los Angeles, Johannes Gutenberg University Mainz, Rennes University Hospital, University of Lyon, University of Rochester, University of Southern California
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 5 Sep 2018 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 8 Sep 2017 (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 study is to determine the risk profile of hepatic artery occlusion in liver transplant recipients who received an aortohepatic conduits, analyzing all consecutive cadaveric liver transplantations from July 2007 to 31st December 2016. Medical records will be examined and adverse events will be analyzed and categorized using the Clavien-Dindo classification and Comprehensive Complication Index.
Detailed description
BACKGROUND
Arterial conduits in liver transplantation are almost as old as the procedure itself. First described by Starzl in 1984, the knowledge remains superficial. Although rarely performed, there is no doubt that thousands of patients' lives were saved because of the use of arterial grafts. However, arterial grafts are known to be associated with a higher rate of occlusion and a lower patient and graft survival when compared to conventional end-to-end anastomosis. In our recent retrospective study, the investigators showed that retransplantation procedure and aspirin in patients' medication are independent risk factors for the need of an arterial conduit. The investigators assume that aspirin could be a surrogate marker for vascular and metabolic status. Furthermore, in a meta-analysis the investigators found a four times higher occlusion rate compared to non-conduits.
Whether the site of conduit placement or certain types of material have an impact on occlusion and graft survival remains unknown. In addition, several studies discuss that antiaggregation or anticoagulation might be protective for occlusion of arterial conduits. Currently, there is no study that investigated this problem, most probably because of low case numbers.
STUDY OBJECTIVES
The primary goal of this study is to conduct a multicenter cohort analysis to define the outcome of different types of conduits and to investigate whether antiplatelet / anticoagulantion has an impact on patency rates.
- Specific aim #1: To identify independent risk factors for early and late occlusion of arterial conduits in liver transplantation.
- Specific aim #2: To compare different placement sites (infrarenal, supraceliac, iliacal, etc.) of arterial conduits in terms of occlusion rates and graft survival.
- Specific aim #3: To investigate whether antiplatelet therapy is protective in terms of arterial patency.
STUDY DESIGN
This will be a multicenter single cohort study including only cases of deceased donor liver transplantation that required an aorto-hepatic or iliac-hepatic conduit for arterial reconstruction. Primary endpoint is 30-day conduit patency. Secondary endpoints include postoperative complications, death, late conduit occlusion, graft and patient survival.
SETTING
This multicenter cohort study will include several high-volume centers worldwide. Each participating center requires a prospective database from that data can be extracted. All consecutive cases of deceased donor liver transplantation requiring an arterial conduit from 1st of January 2007 until 31st of December 2016 are included allowing a minimum follow-up time of 6 months. Data collection at conduit4olt.org will be prospective, structured, anonymized, and encrypted.
INSTITUTIONAL REVIEW POLICY / ETHICAL POLICY
Each participating center is responsible to contact their local ethics committee and receive approval for participation, if applicable. For example, this project is considered as an audit in some countries and thus there is no need for formal approval in the form of a protocol submission.
ELIGIBILITY CRITERIA
Inclusion criteria:
- Liver transplantation requiring aorto-hepatic or iliac-hepatic conduits
- Deceased donor after brain death (DBD) or deceased donor after circulatory death (DCD)
- Whole organ as well as split allografts
- Primary liver transplantation as well as liver retransplantation
- Recipient age ≥18 years
Exclusion criteria:
- Living donor liver transplantation
- Pediatric liver transplantation (recipient age <18 years)
- Arterial reconstruction other than aorto-hepatic or iliac-hepatic conduits
- Multivisceral transplantations
ESTIMATED SAMPLE SIZE
Each center should provide at least 30 cases that meet the inclusion criteria to allow adequate event rates for each outcome.
Statistical methods
The primary and secondary endpoints will be compared with patient and operation characteristics with univariate analysis. ROC Curve analysis will be performed to dichotomize continuous variables. Multivariable analysis (binary logistic and Cox regression) will be performed to identify independent risk factors. Statistical analysis will be performed using R Studio version 1.0.44 (RStudio, Inc. GNU Affero General Public License v3, Boston, MA, 2016) with the graphical user interface rBiostatistics.com beta version (rBiostatistics.com, Zurich, Switzerland, 2016, GNU License).
Christian E. Oberkofler Tim Reese Dimitri A. Raptis Henrik Petrowsky
On behalf of the conduit4olt.org team Swiss HPB Center, Department of Surgery and Transplantation, University Hospital Zurich, Switzerland
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who recieved an aorto-hepatic conduit during liver transplantation
Key inclusion criteria (5 listed)
- Liver transplantation requiring aorto-hepatic or iliac-hepatic conduits
- Deceased donor after brain death (DBD) or deceased donor after circulatory death (DCD)
- Whole organ as well as split allografts
- Primary liver transplantation as well as liver retransplantation
- Recipient age ≥18 years
Key exclusion criteria (4 listed)
- Living donor liver transplantation
- Pediatric liver transplantation (recipient age <18 years)
- Arterial reconstruction other than aorto-hepatic or iliac-hepatic conduits
- Multivisceral transplantations
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 |
|---|---|---|
| Aortohepatic ConduitPlacement of an interposition graft between hepatic artery and aorta during liver transplantation | Procedure or surgery | – |
Primary outcome
Independent risk factors
Time frame: June 2007 til 31st December 2016
To identify independent risk factors for early and late occlusion of arterial conduits in liver transplantation.
Placement sites
Time frame: June 2007 til 31st December 2016
To compare different placement sites (infrarenal, supraceliac, iliacal, etc.) of arterial conduits in terms of occlusion rates and graft survival
Patency Rates
Time frame: June 2007 til 31st December 2016
To investigate whether antiplatelet therapy is protective in terms of arterial patency.
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 18 Mar 2020.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication
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 Aortohepatic Conduit and Patency Rate, run by University of Zurich at 1 site in Switzerland.
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 4 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 18 Mar 2020. 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 Switzerland. 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?
Independent risk factors (time frame: June 2007 til 31st December 2016). The study lists 3 primary outcomes in all. 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 18 Mar 2020.