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

NCT ID: NCT03723317

Last Updated: 2018-10-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1782 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-15
• Study Completion Date: 2018-10-15

Brief 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. 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.

Conditions

Liver Cirrhosis; Liver Failure; Liver Diseases; Transplant Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Training liver transplantation

Patients consecutively transplanted in four European collaborative LT Centres (Ancona, Brussels, Rome Sapienza, and Padua) (N=1,262)

Liver transplantation

Intervention Type: PROCEDURE

First deceased-donor liver transplantation

Validation liver transplantation

Patients consecutively transplanted in the Karolinska Institute (N=520)

Liver transplantation

Intervention Type: PROCEDURE

First deceased-donor liver transplantation

Interventions

Liver transplantation

First deceased-donor liver transplantation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• First transplant
• adult (>18 years)

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Hepatocellular Cancer Liver Transplant Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Quirino Lai, MD PhD

Role: PRINCIPAL_INVESTIGATOR

UCL Brussels

Locations

UCL

Brussels, , Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 32892294 (View on PubMed)

Other Identifiers

#0003

Identifier Type: -

Identifier Source: org_study_id