Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Medical Center Groningen | OTHER |
Not provided
Not provided
Not provided
Not provided
The goal of this observational study is to learn whether extended criteria donor livers can be safely transplanted after sequential hypo- and normothermic machine perfusion in recipients requiring a liver transplant for end-stage liver disease, including a long-term follow-up. The main questions it aims to answer are:
With the increasing shortage of suitable donor livers for transplantation, extended criteria donor (ECD) livers may bridge the gap between available donor organs and donor livers needed. However, these ECD livers are associated with a higher risk of posttransplant complications. With the development of machine perfusion (MP) strategies over the recent years, (dual) hypothermic oxygenated perfusion ((D)HOPE) is established as a safe and effective way to reduce ischemia reperfusion injury. This leads to a decrease in early allograft dysfunction and non-anastomotic biliary strictures (NAS). On the other hand, normothermic machine perfusion (NMP) is mainly used for hepatobiliary functional assessment of liver grafts prior to transplantation. Combining both perfusion techniques through 1 hour of controlled oxygenated rewarming (COR), enables safe selection and transplantation of ECD livers after DHOPE-COR-NMP. Long-term outcomes are now available from two centers.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Adult patients (>18 years) who underwent liver transplantation of donor livers that required resuscitation and viability assessment through the previously published protocol for sequential hypo- and normothermic liver machine perfusion with controlled oxygenated rewarming (DHOPE-COR-NMP) based on a blood-based perfusate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DHOPE-COR-NMP | Procedure | Resuscitation and viability assessment through the previously published protocol of sequential hypo- and normothermic liver machine perfusion with controlled oxygenated rewarming (DHOPE-COR-NMP) based on a blood-based perfusate. |
| Measure | Description | Time Frame |
|---|---|---|
| Death-censored graft survival | Time from liver transplantation until re-transplantation or death due to graft dysfunction, with censoring of subjects who died with a functioning graft. | 1 year post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Overall patient survival | Time from liver transplantation until all-cause death | 1 year post-transplant |
| • Overall graft survival | Time from liver transplantation until re-transplantation or all-cause death. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of post-transplant incidence of biliary interventions | The occurrence and frequency of the composite of one of the following biliary interventions (reported as one single outcome measure): Endoscopic Retrograde Cholangio- and Pancreaticography, drainage performed by percutaneous transhepatic cholangiography and re-interventions for biliary complications (e.g. bile leaks) | Until 6 months after liver transplantation |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Adult patients (>18 years) undergoing liver transplantation of extended criteria donor livers, which therefore required resuscitation and viability assessment through the previously published DHOPE-COR-NMP protocol based on a blood-based perfusate.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Groningen | Provincie Groningen | 9713GZ | Netherlands | ||
| Erasmus Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31420387 | Background | de Vries Y, Berendsen TA, Fujiyoshi M, van den Berg AP, Blokzijl H, de Boer MT, van der Heide F, de Kleine RHJ, van Leeuwen OB, Matton APM, Werner MJM, Lisman T, de Meijer VE, Porte R. Transplantation of high-risk donor livers after resuscitation and viability assessment using a combined protocol of oxygenated hypothermic, rewarming and normothermic machine perfusion: study protocol for a prospective, single-arm study (DHOPE-COR-NMP trial). BMJ Open. 2019 Aug 15;9(8):e028596. doi: 10.1136/bmjopen-2018-028596. | |
| 31633615 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 year post-transplant |
| Number of participants with primary non function | Livers failing to sustain their primary function, leading to death or re-transplantation within 7 days of the primary procedure, in the presence of patent blood supply and outflow (8). | From transplantation until 7 days post-transplant |
| Occurrence of hepatic arterial thrombosis | Radiologically or surgically proven thrombosis of the hepatic artery. | 1 year post-transplant |
| Occurrence of portal vein thrombosis | Radiologically or surgically proven thrombosis of the portal vein. | 1 year post-transplant |
| Occurrence of venous outflow tract obstruction | Radiologically or surgically proven thrombosis of the main hepatic veins or the inferior vena cava. | 1 year post-transplant |
| Occurrence of non-anastomotic biliary strictures | Any irregularity or narrowing of the lumen of the intrahepatic or extrahepatic donor bile ducts, excluding the biliary anastomosis, diagnosed with the use of cholangiography in combination with clinical symptoms (e.g., jaundice or cholangitis) or an elevation of cholestatic laboratory variables, in the presence of a patent hepatic artery (5). | 1 year post-transplant |
| Occurrence of anastomotic biliary strictures | Strictures occurring at the anastomosis of donor choledochal duct and recipient choledochal duct or jejunal Roux-limb. | 1 year post-transplant |
| Occurrence of biliary leakage | Fluid with an elevated (>3x serum) bilirubin level in the abdominal drain or intra-abdominal fluid on or after post-operative day 3 or the need for radiological intervention (i.e. interventional drainage) owing to biliary collections or re-laparotomy due to biliary peritonitis (9). | From 3 days after transplantation until the the first year post-transplant |
| Biliary complications: as a composite | A composite of individually studied outcome measures (reported as one single outcome measure), composed of: non-anastomotic biliary strictures, anastomotic biliary strictures and biliary leakage. | 1 year post-transplant |
| Intensive care stay | Intensive care stay post-transplantation | From transplantation until discharge from the Intensive care unit to the ward after transplantation or date of death from any cause during initial admission, whichever came first, assessed up to 6 months |
| Total hospital stay | Defined as total hospital stay from transplantation until discharge, including intensive care unit stay | From transplantation until discharge after transplantation, or date of death from any cause during initial admission, whichever came first, assessed up to 6 months |
| Rotterdam |
| South Holland |
| 3015GD |
| Netherlands |
| Background |
| van Leeuwen OB, de Vries Y, Fujiyoshi M, Nijsten MWN, Ubbink R, Pelgrim GJ, Werner MJM, Reyntjens KMEM, van den Berg AP, de Boer MT, de Kleine RHJ, Lisman T, de Meijer VE, Porte RJ. Transplantation of High-risk Donor Livers After Ex Situ Resuscitation and Assessment Using Combined Hypo- and Normothermic Machine Perfusion: A Prospective Clinical Trial. Ann Surg. 2019 Nov;270(5):906-914. doi: 10.1097/SLA.0000000000003540. |
| 33626248 | Background | van Rijn R, Schurink IJ, de Vries Y, van den Berg AP, Cortes Cerisuelo M, Darwish Murad S, Erdmann JI, Gilbo N, de Haas RJ, Heaton N, van Hoek B, Huurman VAL, Jochmans I, van Leeuwen OB, de Meijer VE, Monbaliu D, Polak WG, Slangen JJG, Troisi RI, Vanlander A, de Jonge J, Porte RJ; DHOPE-DCD Trial Investigators. Hypothermic Machine Perfusion in Liver Transplantation - A Randomized Trial. N Engl J Med. 2021 Apr 15;384(15):1391-1401. doi: 10.1056/NEJMoa2031532. Epub 2021 Feb 24. |
| 38969242 | Background | Eden J, Bruggenwirth IMA, Berlakovich G, Buchholz BM, Botea F, Camagni S, Cescon M, Cillo U, Colli F, Compagnon P, De Carlis LG, De Carlis R, Di Benedetto F, Dingfelder J, Diogo D, Dondossola D, Drefs M, Fronek J, Germinario G, Gringeri E, Gyori G, Kocik M, Kucukerbil EH, Koliogiannis D, Lam HD, Lurje G, Magistri P, Monbaliu D, Moumni ME, Patrono D, Polak WG, Ravaioli M, Rayar M, Romagnoli R, Sorensen G, Uluk D, Schlegel A, Porte RJ, Dutkowski P, de Meijer VE. Long-term outcomes after hypothermic oxygenated machine perfusion and transplantation of 1,202 donor livers in a real-world setting (HOPE-REAL study). J Hepatol. 2025 Jan;82(1):97-106. doi: 10.1016/j.jhep.2024.06.035. Epub 2024 Jul 3. |
| 35589254 | Background | Schlegel A, Porte R, Dutkowski P. Protective mechanisms and current clinical evidence of hypothermic oxygenated machine perfusion (HOPE) in preventing post-transplant cholangiopathy. J Hepatol. 2022 Jun;76(6):1330-1347. doi: 10.1016/j.jhep.2022.01.024. |
| 21475025 | Background | Foley DP, Fernandez LA, Leverson G, Anderson M, Mezrich J, Sollinger HW, D'Alessandro A. Biliary complications after liver transplantation from donation after cardiac death donors: an analysis of risk factors and long-term outcomes from a single center. Ann Surg. 2011 Apr;253(4):817-25. doi: 10.1097/SLA.0b013e3182104784. |
| 26831547 | 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. |