Research and European Liver Transplant Registry Projects

Research and European Liver Transplant Registry Projects

ELTR-based studies and endorsement of a research project by ELITA

How to apply for endorsement of a research project by ELITA

1. A request should be addressed to the Secretary of ELITA, together with the study protocol.
2. The study should have a multinational and multicenter character.
3. The study should focus on the patients undergoing liver or intestine transplantation.
4. The principal investigator must be a member of ELITA.
5. The study protocol should be approved by all ELITA Board members.

Once the request has been approved by the ELITA Board, the project will be endorsed under the following conditions:

1. In the official correspondence it is stated that "This study is endorsed by the European Liver and Intestine Transplant Association (ELITA)". This should be accompanied by the official logo of ELITA.
2. The ELITA Board is regularly updated about the results of the study (see below). In scientific publications arising from the study, it will be acknowledged that the study was endorsed by the European Liver and Intestine Transplant Association (ELITA).
3. The initiator (the principal investigator) of the study remains fully responsible and accountable for the study. ELITA bears no direct or indirect responsibility for the study.

Regulations for ELTR-based Studies and Publications

1. ELTR data are available to ELITA members whose centres are 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. Requests from third parties: Third parties will be asked to pay a fee for the collection of requested data depending on the extent of dataset and/or for statistical evaluation of the work. An ELITA Board member should be involved in a study concerning clinical issues.

3. To obtain data, a written request should be addressed to the ELITA Secretary with copy to the ELTR General Manager.
The request should contain:
- Title and description of the study;
- Supporting letter by the program director;
- Names and affiliations of the investigators (depending on the type of the study,max. 
2 or 3);
- A disclosure statement regarding potential conflicts of interest (such as financial 
affiliations with pharmaceutical companies);

4. At least one of the authors should be a recognized specialist in the subject.

5. The ELITA Secretary sends the request to the ELTR Scientific Committee, who reviews 
the request and gives its recommendation to the ELITA Board.

6. The ELITA Board decides upon acceptance of the study and assigns one Board member 
who is the liaison person for the conductance of the study and represents ELITA as a 
co-author of the study.

7. A fee of € 1000 per dataset for ELITA members from the centers contributing to the ELTR 
and € 2,000 for members from the centers not contributing to the ELTR will be transferred to ELITA account. If the statistic is requested from ELTR, additional statistical handling will be charged at an hourly rate. For the request from third parties (i.e. industry) a different fee applies.

8. An official notification of the decision of the ELITA Board is sent to the investigator from ELITA Secretary. If the study has been accepted the investigators are requested to sign an agreement with the ELITA regarding the study conduction and publication policy.  

9. Authorship of any publication based on ELTR data (abstracts or full papers) is regulated as follows:
- First, second and last authorship for researchers performing the study;
- the third and the fourth position will be reserved for ELTR member and ELITA liaison person (persons who proofreads the paper, controls adequate conductance, takes care of communication) and it will be defined by the ELITA Board according to the extent of involvement by the ELTR);
- As many authors as possible (as allowed by the journal), one per centre, 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 centres that have participated in the study with patients should be listed in a footnote or appendix, mentioning the program director and one of the collaborators;
- A paragraph entitled “Acknowledgments” containing the text below should be added at the end of each ELTR manuscript: The ELTR is supported by a grant from Astellas, Novartis, Institut Georges Lopez, Bridge to Life and logistic support from the Paul Brousse Hospital (Assistance Publique – Hôpitaux de Paris). The Organ Sharing Organizations: the French ABM (Sami Djabbour and Alain Jolly), the Dutch NTS (Cynthia Konijn), the Eurotransplant Foundation (Marieke Van Meel and Erwin de Vries), the Spanish ONT (Gloria de la Rosa), the UK-Ireland NHSBT (Mike Chilton and Julia Micciche) are acknowledged for the data cross-check and sharing with the ELTR.”

These rules also apply when only a part of the published data is available in the ELTR database.

10. ELITA requires an update on study activities every 6 months beginning from the date of approval of the study, which has to be sent to the Secretary, to the assigned Board member and to the ELTR.

11. ELITA suggests the following timeline for conducting a ELTR-based study:
- Data collection from ELTR: 3 months from the date of study acceptance by ELITA
- Additional data collection from the centres (if necessary): 6 months
- Data evaluation and analysis: 6 months
- Preparation of the manuscript: 5 months

12. If no progress has been made with the study for 2 years, the ELITA Board has the right to cancel the study.

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

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

15. In case the requested data is not (completely) available in the ELTR database, it is allowed to approach ELTR centres for additional data. A request to the centres should be presented on ELITA/ELTR letterhead and should be co-signed by one of the ELITA Board members and by the ELTR General Manager.

16. Similar rules apply when abstracts are presented to congresses.

***PLEASE CLICK HERE TO DOWNLOAD THE REGULATIONS***

***PLEASE CLICK HERE TO DOWNLOAD THE ELITA/ELTR STUDY AGREEMENT***

How to apply for an ELTR-based study

1.  Data from the ELTR data are available to ELITA members who’s center is regularly providing data to the ELTR. Data should preferably be used for research and results of analyses of ELTR data can be published. To obtain data from the ELTR, a written request should be addressed to the Secretary of ELITA with copy to the ELTR custodian.
​2.  This request should contain:
-  Title and description of the project
-  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)
-  Disclosure statement regarding potential conflicts of interest (such as financial affiliations with pharmaceutical companies)
3.  In case the investigator needs to collect additional data from the centers, it is possible to apply for an ELITA-ELTR scholarship. 

ELTR Publications:  

1- Hepatic transplantation in Europe: first report of the European Liver Transplant Registry. Bismuth H et al. Lancet 1987

2- Liver Transplant Registry Report. Gordon RD, Bismuth H. Transplant Proceedings 1991

3- Normalised intrinsic mortality risk in liver transplantation: European Liver Transplant Registry study. Adam R, Cailliez V, Majno P et al. Lancet 2000. Erratum in: Lancet 2001

4-  European Liver Transplant Association. Quality control of the European Liver Transplant Registry: results of audit visits to the contributing centers. Karam V, Gunson B, Roggen F et al. Transplantation 2003

5- Assessing the quality of data in a transplant registry: The European Liver Transplant Registry. Van der Meulen JH1, Jacob M, Copley L. Transplantation 2003

6- European Liver Transplant Association. Evolution of liver transplantation in Europe: report of the European Liver Transplant Registry. Adam R, McMaster P, O'Grady JG et al. Liver Transplantation 2003

7- Liver transplantation in Europe: is there a room for improvement? Adam R, Lucidi V, Karam V. Journal of Hepatology 2005

8- Liver transplantation for Budd-Chiari syndrome: A European study on 248 patients from 51 centres. Mentha G, Giostra E, Majno PE et al. Journal of Hepatology 2006

9- European Liver Transplant Association. Liver Transplantation for Hereditary Hemorrhagic Telangiectasia: Report of the European Liver Transplant Registry. Lerut J, Orlando G, Adam R et al. Annals of Surgery 2006

10- Impact of donor age and year of transplantation on graft and patient survival following liver transplantation for hepatitis C virus. Mutimer DJ, Gunson B, Chen J et al. Transplantation 2006

11- European Liver Transplant Association. 3-month and 12-month mortality after first liver transplant in adults in Europe: predictive models for outcome. Burroughs AK, Sabin CA, Rolles K et al. Lancet 2006

12- The place of liver transplantation in Caroli's disease and syndrome. De Kerckhove L, De Meyer M, Verbaandert C  et al. Transplant International 2006

13- Liver transplant in cystic fibrosis: a poll among European centers. A study from the European Liver Transplant Registry. Melzi ML1, Kelly DA, Colombo C et al. Transplant International 2006

14- Living liver donor mortality: where do we stand? Bramstedt KA. American Journal of Gastroenterology 200615- Documented deaths of hepatic lobe donors for living donor liver transplantation. Trotter JF, Adam R, Lo CM, Kenison J. Liver Transplantation 2006

16- Towards a better liver transplant allocation system. Burroughs AK, Marelli L, Cholongitas E. Liver Transplantation 2007

17- European Liver Transplant Registry. The place of liver transplantation in the treatment of hepatic epitheloid hemangioendothelioma: report of the European liver transplant registry. Lerut JP, Orlando G, Adam R et al. Annals of Surgery 2007

18- Liver transplantation for primary and metastatic liver cancers. Hoti E, Adam R. Transplant International 2008

19- Liver transplantation: the current situation. Adam R, Hoti E. Seminars in Liver Disease 2009

20- Liver transplantation for alcoholic liver disease in Europe: a study from the ELTR (European Liver Transplant Registry). Burra P, Senzolo M, Adam R et al. American Journal of Transplantation 2010

21- European Liver Intestine Transplant Association. Primary liver transplantation for autoimmune hepatitis: a comparative analysis of the European Liver Transplant Registry. Schramm C, Bubenheim M, Adam R et al. Liver Transplantation 2010

22- Liver transplantation for unresectable hepatocellular carcinoma in patients without liver cirrhosis. Mergental H, Porte RJ. Transplant International 2010

23- Liver transplantation for colorectal liver metastases: revisiting the concept. Foss A, Adam R, Dueland S. Transplant International 2010

24- Liver transplantation and vascular tumours. Bonaccorsi-Riani E, Lerut JP. Transplant Internatonal 2010

25- European Liver and Intestine Transplant Association. Excellent survival after liver transplantation for isolated polycystic liver disease: A European Liver Transplant Registry study. Van Keimpema L1, Nevens F, Adam R et al. Transplant International 2011

26- Liver transplantation for erythropoietic protoporphyria in Europe. Wahlin S, Stal P, Adam R et al. Liver Transplantation 2011

27- Validation of the donor risk index in orthotopic liver transplantation within the Eurotransplant region. Blok JJ, Braat AE, Adam R et al. Liver Transplantation 2012

28- Liver transplantation for acute liver failure in Europe: outcomes over 20 years from the ELTR database. Germani G, Theocharidou E, Adam R et al. Journal of Hepatology 2012

29- Evolution of indications and results of liver transplantation in Europe. A report from the European Liver Transplant Registry (ELTR). Adam R, Karam V, Delvart V et al. Journal of Hepatology 2012

30- The Eurotransplant donor risk index in liver transplantation: ET-DRI. Braat AE, Blok JJ, Putter H et al. American Journal of Transplantation 2012

31- The use of fatty liver grafts in modern allocation systems: risk assessment by the balance of risk (BAR) score. Dutkowski P1, Schlegel A, Slankamenac K et al. Annals of Surgery 2012

32- Liver transplantation for unresectable hepatocellular carcinoma in normal livers. Mergental H, Adam R, Ericzon BG et al. Journal of Hepatology 2012

33- Liver transplantation for HBV-related cirrhosis in Europe: an ELTR study on evolution and outcomes. Burra P, Germani G, Adam R et al. Journal of Hepatology 2013

34- Focus. Daniel Shouval. Journal of Hepatology 2013

35- Hepatic hemangiosarcoma: an absolute contraindication to liver transplantation--the European Liver Transplant Registry experience. Orlando G, Adam R, Mirza D et al. Transplantation 2013

36- Incorporation of donor risk into liver allocation algorithms. Braat AE, Blok JJ, Rahmel AO et al. American Journal of Transplantation 2013

37- Liver transplantation for neuroendocrine tumors in Europe-results and trends in patient selection: a 213-case European liver transplant registry study. Le Treut YP, Grégoire E, Klempnauer J et al. Annals of Surgery 2013

38- The difficulty in defining extended donor criteria for liver grafts: the Eurotransplant experience. Silberhumer GR, Rahmel A, Karam V et al. Transplant International 2013

39- A preliminary European Liver and Intestine Transplant Association-European Liver Transplant Registry study on informed recipient consent and extended criteria liver donation. Bruzzone P, Giannarelli D, Adam R  et al. Transplant Proceedings 2013

40- Is liver transplantation justified in septuagenarians? Karam V, Delvart V and Adam R. Le Courrier de la Transplantation 2013

41- Compared efficacy of preservation solutions in liver transplantation: a long-term graft outcome study from the European Liver Transplant Registry. Adam R, Delvart V, Karam V et al. American Journal of Transplantation 2015

42- Regarding ‘‘Compared efficacy of preservation solutions in liver transplantation: A long-term graft outcome study from the European Liver Transplant Registry.’’ Nashan B, Spetzler V, Schemmer P et al. American Journal of Transplantation 2015

43- Reply to Letter Regarding "Compared Efficacy of Preservation Solutions in Liver Transplantation: A Long-Term Graft Outcome Study From the European Liver Transplant Registry". Adam R, Delvart V, Karam V. American Journal of Transplantation 2015

44- Improved survival in liver transplant recipients receiving prolonged-release tacrolimus in the European Liver Transplant Registry. Adam R, Karam V, Delvart V et al. American Journal of Transplantation 2015

45- Liver transplantation for adenomatosis: European experience. Chiche L, David A, Adam R et al. Liver Transplantation 2016

46- Comparison of Two Questionnaires on Informed Consent in "Marginal" Donor Liver. Bruzzone P, Balla A, Quaresima S et al. Transplant Proceedings 2016

47- Strict Selection Alone of Patients Undergoing Liver Transplantation for Hilar Cholangiocarcinoma Is Associated with Improved Survival. Mantel HT, Westerkamp AC, Adam R et al. PLoS One 2016

48- Liver Transplantation for Hepatic Trauma: A Study From the European Liver Transplant Registry. Krawczyk M, Grąt M, Adam R et al. Transplantation 2016

49- Early and Late Factors Impacting Patient and Graft Outcome in Pediatric Liver Transplantation: Summary of an ESPGHAN Monothematic Conference. McLin VA, Allen U, Boyer O et al. Journal of Pediatric Gastroenterology and Nutrition 2017

50- Hepatic Epithelioid Hemangioendothelioma and Adult Liver Transplantation: Proposal for a Prognostic Score Based on the Analysis of the ELTR-ELITA Registry. Lai Q, Feys E, Karam V, Adam R et al. Transplantation 2017

51- More is less: Calling for joining forces for rare pediatric liver tumors research. De Ville de Goyet J, Morland B, Czauderna P. Liver Transplantation 2017

52- Evaluation of HTK Preservation Solutions in Liver Transplantation: A Long-Term Propensity-Based Analysis of Outcome From the European Liver Transplant Registry. Adam R, Cailliez V and Karam V. American Journal of Transplantation 2017

53- Survival of children after liver transplantation for hepatocellular carcinoma. Baumann U, Adam R, Duvoux C et al. Liver Transplantation 2018

54- Locoregional treatments before liver transplantation for hepatocellular carcinoma: a study from the European Liver Transplant Registry. Pommergaard HC, Rostved AA, Adam R et al. Transplant International 2018

55- Outcomes of left split graft transplantation in Europe: report from the European Liver Transplant Registry. Angelico R, Nardi A, Adam R et al. Transplant International 2018

56- Vascular invasion and survival after liver transplantation for hepatocellular carcinoma: a study from the European Liver Transplant Registry. Pommergaard HC, Rostved AA, Adam R et al. HPB (Oxford) 2018

57- A Systematic Review and Meta-Analysis of Cold In Situ Perfusion and Preservation of the Hepatic Allograft: Working Toward a Unified Approach. Adam R, Cailliez V, Segev D, Karam V. Liver Transplantation 2018

58- Impact of DAAs on liver transplantation: Major effects on the evolution of indications and results. An ELITA study based on the ELTR registry. Belli LS, Perricone G, Adam R et al. Journal of Hepatology 2018

59- A changing landscape of liver transplantation: King HCV is dethroned, ALD and NAFLD take over! Terrault NA, Pageaux GP. Journal of Hepatology 2018
60- Predictive Factors for Survival in Children Receiving Liver Transplants for Wilson's Disease: A Cohort Study Using European Liver Transplant Registry Data. Pfister ED, Karch A, Adam R et al. Liver Transplantation 2018

61- 2018 Annual Report of the European Liver Transplant Registry (ELTR) - 50-year evolution of liver transplantation. Adam R, Karam V, Cailliez V et al. Transplant International 2018

62- Trends in liver transplantation for primary biliary cholangitis in Europe over the past three decades. Harms MH, Janssen QP, Adam R et al. Alimentary Pharmacology & Therapeutics 2019

63- Heterogeneity of Bile Duct Management in the Development of Ischemic Cholangiopathy After Liver Transplantation: Results of a European Liver and Intestine Transplant Association Survey. Meurisse N, Monbaliu D, Berlakovich G. et al. Transplant Proceedings 2019

64- Outcomes of liver transplantation for non-alcoholic steatohepatitis: A European Liver Transplant Registry study. Haldar D, Kern B, Hodson J et al. Journal of Hepatology 2019

65- Liver transplantation for non-alcoholic steatohepatitis in Europe: Where do we stand? Durand F, Pavesi M, Cheung R. Journal of Hepatology 2019

66- Improved Survival in Liver Transplant Patients Receiving Prolonged-release Tacrolimus-based Immunosuppression in the European Liver Transplant Registry (ELTR): An Extension Study. Adam R, Karam V, Cailliez V et al. Transplantation 2019