drugset / Trial / NCT07651748
Secretin in Ex-situ Liver Perfusion
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The main objective is to assess whether the use of human synthetic secretin in a clinical (COR-)NMP procedure can restore physiological HCO3- content of the bile during ex-situ NMP.
Timeline
- Start
- 2025-04-26
- Primary completion
- 2026-06
- Completion
- 2026-10
Publications
- Background de Jong IEM, Bodewes SB, van Leeuwen OB, Oosterhuis D, Lantinga VA, Thorne AM, Lascaris B, van den Heuvel MC, Wells RG, Olinga P, de Meijer VE, Porte RJ. Restoration of Bile Duct Injury of Donor Livers During Ex Situ Normothermic Machine Perfusion. Transplantation. 2023 Jun 1;107(6):e161-e172. doi: 10.1097/TP.0000000000004531. Epub 2023 May 23.
- Background Dutch Transplant Registry, Numbers about organ transplantation 2021-2022
- Background Eden J, Sousa Da Silva R, Cortes-Cerisuelo M, Croome K, De Carlis R, Hessheimer AJ, Muller X, de Goeij F, Banz V, Magini G, Compagnon P, Elmer A, Lauterio A, Panconesi R, Widmer J, Dondossola D, Muiesan P, Monbaliu D, de Rosner van Rosmalen M, Detry O, Fondevila C, Jochmans I, Pirenne J, Immer F, Oniscu GC, de Jonge J, Lesurtel M, De Carlis LG, Taner CB, Heaton N, Schlegel A, Dutkowski P. Utilization of livers donated after circulatory death for transplantation - An international comparison. J Hepatol. 2023 May;78(5):1007-1016. doi: 10.1016/j.jhep.2023.01.025. Epub 2023 Feb 4.
- Background Orman ES, Mayorga ME, Wheeler SB, Townsley RM, Toro-Diaz HH, Hayashi PH, Barritt AS 4th. Declining liver graft quality threatens the future of liver transplantation in the United States. Liver Transpl. 2015 Aug;21(8):1040-50. doi: 10.1002/lt.24160.
- Background Nemes B, Gaman G, Polak WG, Gelley F, Hara T, Ono S, Baimakhanov Z, Piros L, Eguchi S. Extended-criteria donors in liver transplantation Part II: reviewing the impact of extended-criteria donors on the complications and outcomes of liver transplantation. Expert Rev Gastroenterol Hepatol. 2016 Jul;10(7):841-59. doi: 10.1586/17474124.2016.1149062. Epub 2016 Mar 2.
- Background van Leeuwen OB, Bodewes SB, Lantinga VA, Haring MPD, Thorne AM, Bruggenwirth IMA, van den Berg AP, de Boer MT, de Jong IEM, de Kleine RHJ, Lascaris B, Nijsten MWN, Reyntjens KMEM, de Meijer VE, Porte RJ. Sequential hypothermic and normothermic machine perfusion enables safe transplantation of high-risk donor livers. Am J Transplant. 2022 Jun;22(6):1658-1670. doi: 10.1111/ajt.17022. Epub 2022 Apr 18.
- Background Tabibian JH, Masyuk AI, Masyuk TV, O'Hara SP, LaRusso NF. Physiology of cholangiocytes. Compr Physiol. 2013 Jan;3(1):541-65. doi: 10.1002/cphy.c120019.
- Background Hohenester S, Wenniger LM, Paulusma CC, van Vliet SJ, Jefferson DM, Elferink RP, Beuers U. A biliary HCO3- umbrella constitutes a protective mechanism against bile acid-induced injury in human cholangiocytes. Hepatology. 2012 Jan;55(1):173-83. doi: 10.1002/hep.24691.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Secretin | Other / unclassified | 16 ug | Other |
Indications
No indication recorded.