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 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.
- Requests from non-ELITA members: Becoming an ELITA member is strongly recommended. Non-members will be asked to pay a fee for the statistical work and an ELITA Board member should be involved in the study.

2. An ELTR centre must be involved in the study.
Requests from third parties: Third parties will be asked to pay a fee for the collection of requested data 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 Custodian.
The request should contain:
- Title and description of the study;
- Supporting letter by the programme 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 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.

6. 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

7. 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 programme director and one of the collaborators;
- These rules also apply when only a part of the published data is available in the ELTR database.

8. 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.

9. 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

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

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

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

13. 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 Custodian.

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

 

***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 Proc 1991

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

4- Quality control of the European Liver Transplant Registry : results of audit visits. Karam V et al. Transplantation 2003

5- Quality control of transplant registries. Morris P, Monaco A. Transplantation 2003

6- Assessing the quality of data in a transplant registry : The European Liver Transplant Registry. Van der Meulen J et al. Transplantation 2003

7- 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

8- Liver transplantation in Europe : is there a room for improvement ? Adam R., Luccidi V., Karam V. et al. J Hepatology 2005

9- Liver transplantation for Budd-Chiari syndrome : A European study on 248 patients from 51 centres. Mentha G et al. J Hepatology 2006

10- Liver Transplantation for Hereditary Hemorrhagic Telangiectasia : Report of the European Liver Transplant Registry. Lerut J et al. Annals of Surgery 2006

11- Impact of donor age and year of transplantation on graft and patient survival following liver transplantation for hepatitis C virus. Mutimer DJ et al. Transplantation 2006

12- 3-month and 12-month mortality after first liver transplant in adults in Europe : predictive models for outcome. Burroughs AK, Sabin CA, Rolles K, Delvart V, Karam V et al. Lancet 2006

13- The place of liver transplantation in Caroli’s disease and syndrome. De Kerckhove L et al. Transplant International 2006

14- Liver transplant in cystic fibrosis : a poll among European centers. A study from the European Liver Transplant Registry. Melzi ML et al. Transplant International 2006

15- Living liver donor mortality : where do we stand ? Bramstedt KA et al. Am J Gastroenterology 2006

16- Documented deaths of hepatic lobe donors for living donor liver transplantation. Trotter JF et al. Liver Transplantation 2006

17- The place of liver transplantation in the treatment of hepatic epitheloid hemangioendothelioma : report of the European liver transplant registry. Lerut J et al. Annals of Surgery 2007

18- Towards a better liver transplant allocation system. Burroughs AK et al. Liver Transplantation 2007

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

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

21- Primary liver transplantation for autoimmune hepatitis : a comparative analysis of the European Liver Transplant Registry. Schramm C et al. Liver Transpl. 2010

22- Liver transplantation for alcoholic liver disease in Europe : a study from the ELTR (European Liver Transplant Registry). Burra P, Senzolo M, Adam R, Delvart V, Karam V et al. Am J Transplant. 2010

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

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

25- Liver transplantation and vascular tumours. Bonaccorsi-Riani E, Lerut JP. Transplant International 2010

26- Excellent survival after liver transplantation for isolated polycystic liver disease : A European Liver Transplant Registry study. van Keimpema L et al. Transplant International 2010

27- Validation of the donor risk index in orthotopic liver transplantation within the Eurotransplant region. Blok JJ et al. Liver Transpl. 2012

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

29- Evolution of indications and results of liver transplantation in Europe. A report from the ELTR. Adam R, Karam V, Delvart V et al. J Hepatol. 2012

30- The Eurotransplant donor risk index in liver transplantation : ET-DRI. Braat AE et al. Am J Transplant. 2012

31- The use of fatty liver grafts in modern allocation systems : risk assessment by the balance of risk (BAR) score. Dutkowski P et al. Ann Surg. 2012

32- Liver transplantation for unresectable hepatocellular carcinoma in normal livers. Mergental H et al. J Hepatol. 2012

33- Hepatic hemangiosarcoma : an absolute contraindication to liver transplantation—the ELTR experience. Orlando G et al. Transplantation. 2013

34- Liver transplantation for HBV-related cirrhosis in Europe : an ELTR study on evolution and outcomes. Burra P et al. J Hepatol. 2013

35- Incorporation of donor risk into liver allocation algorithms. Braat AE et al. Am J Transplant. 2013

36- Liver transplantation for neuroendocrine tumors in Europe-results and trends in patient selection : a 213-case European liver transplant registry study. Le Treut YP et al. Ann Surg. 2013

37- The difficulty in defining extended donor criteria for liver grafts : the Eurotransplant experience. Silberhumer GR et al. Transpl Int. 2013

38- A preliminary European Liver and Intestine Transplant Association-European Liver Transplant Registry study on informed recipient consent and extended criteria liver donation. Bruzzone P et al. Transplant Proc. 2013

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

40- 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. Am J Transplant. 2015

41- Improved survival in liver transplant recipients receiving prolonged-release tacrolimus in the European Liver Transplant Registry. Adam R, Karam V, Delvart V et al. Am J Transplant. 2015

42- 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. Am J Transplant. 2015

43- Liver transplantation for adenomatosis: European experience. Chiche L. et al. Liver transplantation 2016

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