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Article History

Received: 28 March 2023

Accepted: 22 August 2023

First Online: 21 September 2023

Declarations

:

: The authors declare no competing interests.

: The study protocol was approved by the central Ethics Committee through CTIS procedure (Reference N°2022-501181-22-01 - Date: November 9th, 2022). The study is approved by each participating institution’s Institutional Review Board. This study will be conducted according to the principles of the Declaration of Helsinki (version October 2013) and in accordance with the Medical Research Involving Human Subjects Act (WMO). The patients treating physicians, local investigator, or research nurse of the participating centers follow Good Clinical Practice (GCP) and other applicable regulations in informing the patient and obtaining consent. Before informed consent may be obtained, the investigator should provide the patient ample time and opportunity to inquire about details of the trial and to decide whether or not to participate in the trial. All questions about the trial should be answered to the satisfaction of the patient. Patients are well informed that participation in voluntary and that they may withdraw at any point during the study. Additional informed consent for the biological collateral study includes consent for collection and use of biological specimens (i.e. blood and tissue). Written informed consent of patients is required before enrolment in the trial or study related procedures take place. All data provided to the sponsor will be handled with strict confidentiality, assuring anonymity of patients. To guarantee the security of data, and to ensure compliance with the GDPR and to ensure that the principles of confidentiality, integrity and availability of data are respected, several measures have been put in place, in particular:•The anonymized participant information will be stored in locked file cabinets in areas with limited access with key or batch control.•All databases will be secured with encrypted and password-protected access systems and audit trail.This protocol is endorsed by the Belgian Group of Digestive Oncology (BGDO) and supported by the pancreatic national cooperative network. The sponsor encourages acknowledgement of all individuals/organizations involved in the funding or conduct of the study, including medical writers or statisticians subject to the consent of each individual and entity concerned, including acknowledgement of the sponsor. The results of this study may be published or communicated to scientific meetings by the investigators involved in the study.The sponsor has a liability insurance which will be annually renewed in the event of any indemnity and compensation related to the trial.

: Not applicable.

: CUB Hôpital Erasme (ULB).Department of Gastroenterology, Hepato-Pancreatology and Digestive Oncology.Route de Lennik 808, 1070 Brussels.Belgium.jl.vanlaethem@erasme.ulb.ac.be.Phone: +32 2 555 3714t.The sponsor has ultimate authority over all the activities related to this study and will have access to the final trial dataset.

: <u>Steering Committee</u>.From ULB: C. Bouchart, J. Navez, L. Moretti, M. Paesmans, P. Demetter, N. D’haene, J. Closset, JL. Van Laethem.Form other Belgian universities: I. Borbath, C. Hubert, G. Van Ooteghem, T. Vandamme, G. Roeyen, K. Geboes, F. Berrevoets.<u>Patients’ group overseeing the trial</u> : PISARO group (Institut Jules Bordet).<u>Statistician</u>: Mrs Marianne Paesmans, MSc, Institut Jules Bordet - Data Centre.<u>Data management team</u>: BGDO trial office: Ine De Bruyne (i.debruyne@bgdo.org) and Lina Dewever (lina.dewever@bgdo.org).<u>Administrative coordination</u>: Mia Persoons, Clinical Research Unit, Department of Gastroenterology and Digestive Oncology, CUB Hôpital Erasme (mia.persoons@ hubruxelles.be ).<u>Study coordinators at sponsor’s site</u>: Axelle Ghilain (Axelle.ghilain@ hubruxelles.be) and/or Camilla Previtali (Camilla.previtali@ hubruxelles.be), Clinical Research Unit, Department of Gastroenterology and Digestive Oncology, CUB Hôpital Erasme.