Tachezy, Michael
Chon, Seung-Hun http://orcid.org/0000-0002-8923-6428
Rieck, Isabel
Kantowski, Marcus
Christ, Hildegard
Karstens, Karl
Gebauer, Florian
Goeser, Tobias
Rösch, Thomas
Izbicki, Jakob R.
Bruns, Christiane J.
Funding for this research was provided by:
Universitätsklinikum Köln
Article History
Received: 23 October 2020
Accepted: 6 May 2021
First Online: 2 June 2021
Declarations
:
: The ESOLEAK trial is conducted in accordance with the Declaration of Helsinki. The study protocol, informed consent, and patient information have been approved by the ethics committee of the University of Cologne on 2 July 2019, 19-1201. We confirm that informed consent will be obtained from all study participants.Any modification of the protocol which may impact the conduct of the study and potential benefit for the patient or may affect the patient’s safety, including changes of study objectives, study design, patient population, sample sizes, study procedures, or significant administrative aspects, will require a formal amendment to the protocol.Administrative changes of the protocol are minor corrections and/or clarifications that have no effect on the way the study will be conducted. These administrative changes will be agreed upon by the study group and will be documented in a memorandum. The Ethics Committee may be notified in case of administrative changes.
: The final manuscript will be circulated between the PIs. The PIs suggest and justify the names for authors. Disputes regarding authorship will be settled by the participating chairs of the departments. The right of senior authorship will fall to the study center with the higher number of included and competed study participants. Vice versa, the (shared) first author will be placed by the study center with the lesser number of patients. Professional writing assistance will be mentioned in the Acknowledgements.
: The authors declare that they have no competing interests.