European Liver Transplant Registry (E.L.T.R)

A service of The European Liver and Intestine Transplant Association (E.L.I.T.A)

Data of more than 130,000 LT performed in Europe since 1968

168 centers - 32 Countries

What is the role of scientific registries?

The role of scientific registries

- Highly selected patient populations (often low immunological risk) due to stringent inclusion and exclusion criteria:

• Not always representative of real-world population

• Findings may not extrapolate to other populations

- Patient management dictated by study protocol:

• May not reflect real-world clinical practice

- Limited duration & long time before the analysis of results (risk to become obsolete)

- Barriers to clinician and patient participation:

• Time constraints, staff and training, consent procedures

Randomized Clinical Trials

- Representative of real-world clinical practice and outcomes

• Management of patients not determined by protocol

- Larger and more diverse group of patients

• Includes those not typically included in RCTs

• Outcome results applicable to wide range of patients

- Prospective and retrospective long-term data

- A tool for ‘daily’ use and immediate results

However:

– Challenge of potential bias and confounding

– Potential for missing data

Registries

Conclusion: Randomised controlled trials (RCTs) and registry studies have

complementary roles in evaluating outcomes in liver transplantation

ELTR Audit visits

OSOs data cross-check

Background

The European Liver Transplant Registry (ELTR)

• Objectives:

– Registry of all liver transplantation procedures in Europe

– Link between European liver transplant centres

– Scientific use and publications

• One of the largest and most robust registries of its kind:

– Service of ELITA (a section of ESOT)

– Liver transplant data prospectively collected since 1968

– Represents >97% of the overall European liver transplant data

– Up to December 2015: up to 130,000 liver transplants, 168 centres, 32 Countries

R. CALNE

UK

H. BISMUTH

France

R. PICHLMAYR

Germany

Key opinion leaders and Pioneers of liver transplantation in Europe

Data Management & Quality Control

Data management

• Standardised questionnaire to capture information on:

EDC* Platform

Real time Better outcome for everyone

Quality & Innovation

• Capture of data on line

• Quickly roll out questionnaire amendments

• Queries & corrections

• Statistics (pre-programed + personnalised), PP

presentation and website figures

• Possibility of real time export data for ELTR studies

• Audit trail traceability of all data modification

* Electronic Data Capture

Data management

• Voluntary participation

• Standard computerised online database

• ELTR Expert Committee:

– Periodic meetings to review questionnaire

• Workshops every 2 years: – Transplant coordinators, data managers, organ sharing

organisation representatives

10th ELTR Workshop Held in Paris, December 2014.

10th ELTR Workshop Held in Paris, December 2014.

10th ELTR Workshop Held in Paris, December 2014.

10th ELTR Workshop Held in Paris, December 2014.

Data quality

• Data checked for completeness and consistency:

– Intra- and inter-updates routinely performed

– Agreements with European organ sharing organisations to exchange data and cross-check common data

• Annual auditing process:

– 5 randomly conducted audit visits/yr

– 120 centres audited since 1988

• Newsletter every year:

– Overview of all the events and projects

New ELTR Platform

Public Professionals

Schema of the cycle of data entry

ELTRWeb

Listing queries

Real time calculation of scores

ELTRWeb platform

ELTRWeb platform Real time European and Center specific results

ELTRWeb platform

data exporting

Studies and Publications

Impact on clinical practice?

Development of risk models for liver transplantation mortality according to characteristics of donor and recipient, and the transplant procedure.

Regulations for ELTR-based studies and publications

1. The ELTR data are available to ELITA members who’s center is regularly contributing data to the ELTR. Data can be used to perform scientific studies which should preferably lead to a publication in a peer-reviewed journal

2. To obtain the data, a written request should be addressed to the ELITA

Secretary with copy to the ELTR custodian. The request should contain: - Title and description of the study - Specification of the data that should be obtained from the ELTR - Supporting letter by the program director - Names and affiliations of the investigators (max. 3) - A disclosure statement regarding potential conflicts of interest

3. One of the authors should be a recognised specialist in the subject

Regulations for ELTR-based studies and publications

4. Authorship of any publication based on ELTR data (abstracts or full papers) is regulated as follows:

- First, second and last authorship for those performing the study - Third authorship to the custodian of ELTR - Fourth authorship to be decided by the ELITA board (person who proofreads

the paper) - As many authors as possible (this means as allowed by the journal), one per

center, according to the number of patients included in the study - After the last author the statement 'for the European Liver and Intestine

Transplant Association (ELITA)' - All centers that have participated with patients in the study, should be listed in

a footnote or appendix, mentioning the program director and one of the collaborators

5. Manuscripts should always be presented to the ELITA Board for approval prior to submission

6. The choice for a journal is made in agreement with the Board of ELITA

Similar rules account for abstracts to congresses.

First publication of ELTR 1987

Example of ELTR Publications

Example of ELTR publications Overall risk factors

Example of ELTR publications Overall risk factors

Example of ELTR publications Allocation systems

Example of ELTR publications Allocation systems

Example of ELTR publications Allocation systems

Example of ELTR publications General review

Example of ELTR publications General review

Example of ELTR publications Evolution and results

Example of ELTR publications Data Management & Quality Control

Example of ELTR publications Data Management & Quality Control

Example of ELTR publications Disease specific: Alcoholic Liver Disease

Example of ELTR publications Disease specific: Acute Liver Failure

Example of ELTR publications Disease specific: Autoimmune Hepatitis

Example of ELTR publications Disease specific: Hepatic Hemangiosarcoma

Example of ELTR publications Disease specific: HBV-Related Cirrhosis

Example of ELTR publications Disease specific: Hepatic Epitheloid Hemangioendothelioma

Example of ELTR publications Disease specific: Caroli’s Disease

Example of ELTR publications Disease specific: Hereditary Hemorrhagic Telangiectasia

Example of ELTR publications Disease specific: Erythropoietic Protoporphyria

Example of ELTR publications Disease specific: Hepatocellular Carcinoma

Example of ELTR publications Disease specific: Neuroendocrine Tumors

Example of ELTR publications Disease specific: Preservation Solutions

Example of ELTR publications Disease specific: Prolonged-Release Tacrolimus

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94

142 152 159 159

204 186

208

256 234 238

302

267

324 342

250

Academic Citations of ELTR Tracked by Google Scholar

> 250 citations/yr since 2011 August

A model of European scientific collaboration since 1986

Organ Sharing

Organisations

Organ Exchange

Organisations

Scientific

Societies

ELTR Team

René Adam MD, PhD, Chairman

Vincent H Karam PhD Data management and quality control

Valérie Delvart Biostatistics

Anne-Marie Lamerant Secretary

the support of:

The ELTR continue to evolve thanks to the participation of the 168 centers and to

the colaboration with: