Associated Balance of Risk Score - Comprehensive Complication Index for the Prediction of Post-transplant Survival

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.

Study Overview

• Status: Completed
• Conditions: Liver Diseases; Liver Failure; Liver Cirrhosis; Transplant Failure
• Intervention / Treatment: Procedure: Liver transplantation

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 Type: Observational
• Enrollment (Actual): 1782

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
    • UCL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients transplanted for any liver pathology undergoing a first transplant.

Description

Inclusion Criteria:

• First transplant
• adult (>18 years)

Exclusion Criteria:

• living donation
• re-transplant
• combined transplant
• domino transplant
• paediatric transplant

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Training liver transplantation; Patients consecutively transplanted in four European collaborative LT Centres (Ancona, Brussels, Rome Sapienza, and Padua) (N=1,262)	Procedure: Liver transplantation; First deceased-donor liver transplantation
Validation liver transplantation; Patients consecutively transplanted in the Karolinska Institute (N=520)	Procedure: Liver transplantation; First deceased-donor liver transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Five-year post-transplant graft survival	Number of participants experiencing a graft loss for any reason	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-transplant rate	Number of participants experiencing a re-transplant for any reason	5 years

Collaborators and Investigators

• Sponsor: European Hepatocellular Cancer Liver Transplant Group
• Investigators: Principal Investigator: Quirino Lai, MD PhD, UCL Brussels

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): October 15, 2018
• Study Completion (Actual): October 15, 2018

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: October 26, 2018
• First Posted (Actual): October 29, 2018

Study Record Updates

• Last Update Posted (Actual): October 29, 2018
• Last Update Submitted That Met QC Criteria: October 26, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Hepatic Insufficiency; Pathologic Processes; Fibrosis; Liver Diseases; Liver Failure; Liver Cirrhosis
• Other Study ID Numbers: #0003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No