Non-alcoholic steatohepatitis in liver transplant recipients diagnosed by serum cytokeratin 18 and transient elastography: A prospective study
Alshaima Alhinai, Experimental Medicine, McGill University, Montreal H4A3J1, Canada
Afsheen Qayyum-Khan, Patrick Samaha, Marc Deschenes, Philip Wong, Tian-Yan Chen, Giada Sebastiani, Medicine, McGill University Health Centre, Montreal H4A3J1, Canada
Xun Zhang, Departments of Pediatrics and Epidemiology, McGill University, Montreal H4A3J1, Canada
Peter Metrakos, Cancer Research Program, The Research Institute of McGill University and The Research Institute of McGill University Health Center, Montreal H4A3J1, Canada
Peter Ghali, Medicine, University of Florida, Jacksonville, Florida 32218, United States
Author contributions: Alhinai A and Sebastiani G contributed to study design and first draft of the article; Alhinai A, Qayyum-Khan A, Samaha P, Metrakos P, Deschenes M, Wong P, Ghali P, Chen TY and Sebastiani G contributed to data and interpretation of data; Zhang X contributed to statistical analysis; Sebastiani G contributed to conception and statistical analysis; and all authors approved the final version of the article.
Supported by the Canadian Donation and Transplantation Research Program of the Canadian Society of Transplantation (grant competition 2014); Sebastiani G is supported by a Senior Salary Award from Fonds de la Recherche en Santé du Quebéc (FRQS) (No. #296306).
Institutional review board statement: The study was approved by the Research Ethics Board of the Research Institute of MUHC (code 15-002-MUHC). The study was conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines.
Clinical trial registration statement: The study was registered at ClinicalTrials.gov (NCT03128918).
Informed consent statement: All patients provided their informed written consent prior to participation.
Conflict-of-interest statement: Deschenes M has served as an advisory board member for Merck, Janssen, Gilead; Wong P has acted as consultant for BMS, Gilead, Merck, Novartis; Sebastiani G has acted as speaker for Pfizer, Merck, Novonordisk, Novartis, Gilead and AbbVie, served as an advisory board member for Merck, Gilead, Pfizer, Allergan, Novonordisk, Intercept and Novartis and has received research funding from Merck and Theratec. All other authors have no conflicts of interest to declare.
Data sharing statement: According to stipulations of the patient consent form signed by all study participants, ethical restrictions imposed by our Institutional Ethics review boards (Institutional Ethics Review Board Biomedical B Research Ethics Board of the McGill University Health Centre), and legal restrictions imposed by Canadian law regarding clinical trials, anonymized data are available upon request. Please send data access requests to Sheldon Levy, Biomedical B (BMB) Research Ethics Board (REB) Coordinator Centre for Applied Ethics, 5100, boul. de Maisonneuve Ouest, 5th floor, Office 576, Montréal, Québec, H4A 3T2, Canada.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Giada Sebastiani, MD, Associate Professor, Medicine, McGill University Health Centre, 1001 boulevard Decarie, Montreal H4A3J1, Canada. firstname.lastname@example.org
Received: July 1, 2021
Peer-review started: July 1, 2021
First decision: July 13, 2021
Revised: July 25, 2021
Accepted: November 14, 2021
Article in press: November 14, 2021
Published online: December 27, 2021