Liver CirrhosisNCT03723317
Associated Balance of Risk Score - Comprehensive Complication Index for the Prediction of Post-transplant Survival
An observational study of Liver Cirrhosis and Liver Failure, run by European Hepatocellular Cancer Liver Transplant Group at 1 site in Belgium.
Trial summary
In recent years, several scoring systems have been developed aimed at predicting early post-LT graft function. However, many of them showed poor efficacy when long-term survivals were tested. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Cirrhosis, Liver Failure, Liver Diseases
- What is being tested?
- Liver transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 1,782 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Jan 2018to 15 Oct 2018
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients transplanted for any liver pathology undergoing a first transplant.
Who may be able to join
- First transplant
- adult (>18 years)
Who cannot join
- living donation
- re-transplant
- combined transplant
- domino transplant
- paediatric transplant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Associated Balance of Risk Score - Comprehensive Complication Index for the Prediction of Long-term Survival After Liver Transplantation
In recent years, several scoring systems have been developed aimed at predicting early post-LT graft function. However, many of them showed poor efficacy when long-term survivals were tested. Moreover, the necessity to find an easy-to-use score represents another obstacle, with several scores composed by numerous, difficult to find, variables. Recently, the pre-LT Balance of Risk (BAR) and the post-LT Comprehensive Complication Index (CCI) have been created, but their external validation and integration in this setting is lacking.
This study aims at constructing an easy-to-use score system based on the combination of a small number of pre- and immediately post-liver transplant (LT) independent variables, in order to accurately predict long-term graft survival after LT.
Read the detailed description
In the last years, several scoring systems have been developed with the intent to predict waiting-list mortality or early allograft dysfunction (EAD) after liver transplantation (LT). The Model for End-stage Liver Disease (MELD) is recognised as the most accurate liver allograft allocation model by prioritising patients according to the severity of their disease. However, several studies showed that MELD alone failed to predict early and late post-transplant clinical course. Consequently, other scoring systems based on pre-LT or post-LT variables have been developed, with the intent to identify high-risk cases for death, graft loss or re-transplantation (re-LT). Among them, two pre-LT scores, namely the D-MELD and Balance of Risk (BAR), showed to well predict early post-LT survival. Similarly, some post-LT scores were able to estimate EAD, and, thereby, to predict the probabilities of early re-LT and patient death. Interestingly, all of these scores, especially those based on pre-LT variables, resulted in a scarce prediction of long-term (five-year) survivals.
Recently, the Comprehensive Complication Index (CCI) has been developed in order to better capture complication rates after surgery. Some reports reported its excellent prognostic ability in different fields. However, up to now, no studies investigated the role of CCI concerning long-term prognostication of graft loss in LT.
This study aims at constructing an easy-to-use score system based on the combination of a small number of pre- and immediately post-LT independent variables, in order to accurately predict five-year post-LT graft survival. Both external and internal validations of the score were performed.
- Conditions
- Liver Cirrhosis, Liver Failure, Liver Diseases, Transplant Failure
- Being tested
- Liver transplantation
- Medical subject headings
- Liver Cirrhosis, Liver Failure, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver transplantationProcedure or surgery
First deceased-donor liver transplantation
| Study group | Role | What they receive |
|---|---|---|
| Training liver transplantation | Patients consecutively transplanted in four European collaborative LT Centres (Ancona, Brussels, Rome Sapienza, and Padua) (N=1,262) Receives: Procedure: Liver transplantation | |
| Validation liver transplantation | Patients consecutively transplanted in the Karolinska Institute (N=520) Receives: Procedure: Liver transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Five-year post-transplant graft survival
Number of participants experiencing a graft loss for any reason
Measured: 5 years
Secondary outcomes (1)
Re-transplant rate
Number of participants experiencing a re-transplant for any reason
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start15 Jan 2018
- Primary completion15 Oct 2018
- Study completion15 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies 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
- 1,782 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Hepatocellular Cancer Liver Transplant Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Quirino Lai, MD PhD, Principal investigator, UCL Brussels
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723317
- Sponsor's protocol ID
- #0003
- Status last verified
- Oct 2018
- First submitted
- 25 Oct 2018
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lai Q, Melandro F, Nowak G, Nicolini D, Iesari S, Fasolo E, Mennini G, Romano A, Mocchegiani F, Ackenine K, Polacco M, Marinelli L, Ciccarelli O, Zanus G, Vivarelli M, Cillo U, Rossi M, Ericzon BG, Lerut J. The role of the comprehensive complication index for the prediction of survival after liver transplantation. Updates Surg. 2021 Feb;73(1):209-221. doi: 10.1007/s13304-020-00878-4. Epub 2020 Sep 6.
PubMed 32892294
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associated Balance of Risk Score - Comprehensive Complication Index for the Prediction of Long-term Survival After Liver Transplantation
- ClinicalTrials.gov ID
- NCT03723317
- Acronym / sponsor ID
- #0003
- Conditions
- Liver Cirrhosis, Liver Failure, Liver Diseases, Transplant Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,782 participants (actual)
- Lead sponsor
- European Hepatocellular Cancer Liver Transplant GroupUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 29 Oct 2018 (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.
In recent years, several scoring systems have been developed aimed at predicting early post-LT graft function. However, many of them showed poor efficacy when long-term survivals were tested. Moreover, the necessity to find an easy-to-use score represents another obstacle, with several scores composed by numerous, difficult to find, variables. Recently, the pre-LT Balance of Risk (BAR) and the post-LT Comprehensive Complication Index (CCI) have been created, but their external validation and integration in this setting is lacking.
This study aims at constructing an easy-to-use score system based on the combination of a small number of pre- and immediately post-liver transplant (LT) independent variables, in order to accurately predict long-term graft survival after LT.
Detailed description
In the last years, several scoring systems have been developed with the intent to predict waiting-list mortality or early allograft dysfunction (EAD) after liver transplantation (LT). The Model for End-stage Liver Disease (MELD) is recognised as the most accurate liver allograft allocation model by prioritising patients according to the severity of their disease. However, several studies showed that MELD alone failed to predict early and late post-transplant clinical course. Consequently, other scoring systems based on pre-LT or post-LT variables have been developed, with the intent to identify high-risk cases for death, graft loss or re-transplantation (re-LT). Among them, two pre-LT scores, namely the D-MELD and Balance of Risk (BAR), showed to well predict early post-LT survival. Similarly, some post-LT scores were able to estimate EAD, and, thereby, to predict the probabilities of early re-LT and patient death. Interestingly, all of these scores, especially those based on pre-LT variables, resulted in a scarce prediction of long-term (five-year) survivals.
Recently, the Comprehensive Complication Index (CCI) has been developed in order to better capture complication rates after surgery. Some reports reported its excellent prognostic ability in different fields. However, up to now, no studies investigated the role of CCI concerning long-term prognostication of graft loss in LT.
This study aims at constructing an easy-to-use score system based on the combination of a small number of pre- and immediately post-LT independent variables, in order to accurately predict five-year post-LT graft survival. Both external and internal validations of the score were performed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training liver transplantation | – | Procedure: Liver transplantationPatients consecutively transplanted in four European collaborative LT Centres (Ancona, Brussels, Rome Sapienza, and Padua) (N=1,262) |
| Validation liver transplantation | – | Procedure: Liver transplantationPatients consecutively transplanted in the Karolinska Institute (N=520) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients transplanted for any liver pathology undergoing a first transplant.
Key inclusion criteria (2 listed)
- First transplant
- adult (>18 years)
Key exclusion criteria (5 listed)
- living donation
- re-transplant
- combined transplant
- domino transplant
- paediatric transplant
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 |
|---|---|---|
| Liver transplantationFirst deceased-donor liver transplantation | Procedure or surgery | Training liver transplantation, Validation liver transplantation |
Primary outcome
Five-year post-transplant graft survival
Time frame: 5 years
Number of participants experiencing a graft loss for any reason
1 secondary outcome
Re-transplant rate
Time frame: 5 years
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 Oct 2018.
- Derived from this study: PubMed 32892294Lai Q, Melandro F, Nowak G, Nicolini D, Iesari S, Fasolo E, Mennini G, Romano A, Mocchegiani F, Ackenine K, Polacco M, Marinelli L, Ciccarelli O, Zanus G, Vivarelli M, Cillo U, Rossi M, Ericzon BG, Lerut J. The role of the comprehensive complication index for the prediction of survival after liver transplantation. Updates Surg. 2021 Feb;73(1):209-221. doi: 10.1007/s13304-020-00878-4. Epub 2020 Sep 6.
- Individual participant dataSharing planned: No
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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.
Quirino Lai, MD PhD principal investigator
UCL Brussels
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 Cirrhosis and Liver Failure, run by European Hepatocellular Cancer Liver Transplant Group at 1 site in Belgium.
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 2 inclusion and 5 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 Oct 2018. 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 Belgium. 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?
Five-year post-transplant graft survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03723317, which also lists 1 linked publication.
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 Oct 2018.