Study protocol for a multicenter randomized controlled trial to compare the efficacy of end-ischemic dual hypothermic oxygenated machine perfusion with static cold storage in preventing non-anastomotic biliary strictures after transplantation of liver grafts donated after circulatory death: DHOPE-DCD trial
Abstract Background The major concern in liver transplantation of grafts from donation after circulatory death (DCD) donors remains the high incidence of non-anastomotic biliary strictures (NAS). Machine perfusion has been proposed as an alternative strategy for organ preservation which reduces isch...
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| Format: | Article |
| Language: | English |
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BMC
2019-03-01
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| Series: | BMC Gastroenterology |
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| Online Access: | http://link.springer.com/article/10.1186/s12876-019-0956-6 |
| _version_ | 1819073296513105920 |
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| author | Rianne van Rijn Aad P. van den Berg Joris I. Erdmann Nigel Heaton Bart van Hoek Jeroen de Jonge Henri G. D. Leuvenink Shekar V. K. Mahesh Sarah Mertens Diethard Monbaliu Paolo Muiesan M. Thamara P. R. Perera Wojciech G. Polak Xavier Rogiers Roberto I. Troisi Yvonne de Vries Robert J. Porte |
| author_facet | Rianne van Rijn Aad P. van den Berg Joris I. Erdmann Nigel Heaton Bart van Hoek Jeroen de Jonge Henri G. D. Leuvenink Shekar V. K. Mahesh Sarah Mertens Diethard Monbaliu Paolo Muiesan M. Thamara P. R. Perera Wojciech G. Polak Xavier Rogiers Roberto I. Troisi Yvonne de Vries Robert J. Porte |
| author_sort | Rianne van Rijn |
| collection | DOAJ |
| description | Abstract Background The major concern in liver transplantation of grafts from donation after circulatory death (DCD) donors remains the high incidence of non-anastomotic biliary strictures (NAS). Machine perfusion has been proposed as an alternative strategy for organ preservation which reduces ischemia-reperfusion injury (IRI). Experimental studies have shown that dual hypothermic oxygenated machine perfusion (DHOPE) is associated with less IRI, improved hepatocellular function, and better preserved mitochondrial and endothelial function compared to conventional static cold storage (SCS). Moreover, DHOPE was safely applied with promising results in a recently performed phase-1 study. The aim of the current study is to determine the efficacy of DHOPE in reducing the incidence of NAS after DCD liver transplantation. Methods This is an international multicenter randomized controlled trial. Adult patients (≥18 yrs. old) undergoing transplantation of a DCD donor liver (Maastricht category III) will be randomized between the intervention and control group. In the intervention group, livers will be subjected to two hours of end-ischemic DHOPE after SCS and before implantation. In the control group, livers will be subjected to care as usual with conventional SCS only. Primary outcome is the incidence of symptomatic NAS diagnosed by a blinded adjudication committee. In all patients, magnetic resonance cholangiography will be obtained at six months after transplantation. Discussion DHOPE is associated with reduced IRI of the bile ducts. Whether reduced IRI of the bile ducts leads to lower incidence of NAS after DCD liver transplantation can only be examined in a randomized controlled trial. Trial registration The trial was registered in Clinicaltrials.gov in September 2015 with the identifier NCT02584283. |
| first_indexed | 2024-12-21T17:51:22Z |
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| id | doaj.art-ce1fbf6016ea4904aaf37ee5f903dffe |
| institution | Directory Open Access Journal |
| issn | 1471-230X |
| language | English |
| last_indexed | 2024-12-21T17:51:22Z |
| publishDate | 2019-03-01 |
| publisher | BMC |
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| series | BMC Gastroenterology |
| spelling | doaj.art-ce1fbf6016ea4904aaf37ee5f903dffe2022-12-21T18:55:21ZengBMCBMC Gastroenterology1471-230X2019-03-0119111210.1186/s12876-019-0956-6Study protocol for a multicenter randomized controlled trial to compare the efficacy of end-ischemic dual hypothermic oxygenated machine perfusion with static cold storage in preventing non-anastomotic biliary strictures after transplantation of liver grafts donated after circulatory death: DHOPE-DCD trialRianne van Rijn0Aad P. van den Berg1Joris I. Erdmann2Nigel Heaton3Bart van Hoek4Jeroen de Jonge5Henri G. D. Leuvenink6Shekar V. K. Mahesh7Sarah Mertens8Diethard Monbaliu9Paolo Muiesan10M. Thamara P. R. Perera11Wojciech G. Polak12Xavier Rogiers13Roberto I. Troisi14Yvonne de Vries15Robert J. Porte16Section Hepatobiliary Surgery and Liver Transplantation, Department of Surgery, University Medical Center GroningenDepartment of Gastroenterology and Hepatology, University Medical Center GroningenDepartment of Surgery, Leiden University Medical CenterInstitute of Liver Studies, Kings College Hospital NHS Foundation TrustDepartment of Gastroenterology and Hepatology, Leiden University Medical CenterDepartment of Surgery, Erasmus University Medical CenterSurgical Research Laboratory, Department of Surgery, University Medical Center GroningenDepartment of Radiology, University Medical Center GroningenDepartment of Abdominal Transplantation Surgery, University Hospitals of LeuvenDepartment of Abdominal Transplantation Surgery, University Hospitals of LeuvenLiver Unit, Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation TrustLiver Unit, Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation TrustDepartment of Surgery, Erasmus University Medical CenterDepartment of Transplant Surgery, Ghent University HospitalDepartment of Transplant Surgery, Ghent University HospitalSection Hepatobiliary Surgery and Liver Transplantation, Department of Surgery, University Medical Center GroningenSection Hepatobiliary Surgery and Liver Transplantation, Department of Surgery, University Medical Center GroningenAbstract Background The major concern in liver transplantation of grafts from donation after circulatory death (DCD) donors remains the high incidence of non-anastomotic biliary strictures (NAS). Machine perfusion has been proposed as an alternative strategy for organ preservation which reduces ischemia-reperfusion injury (IRI). Experimental studies have shown that dual hypothermic oxygenated machine perfusion (DHOPE) is associated with less IRI, improved hepatocellular function, and better preserved mitochondrial and endothelial function compared to conventional static cold storage (SCS). Moreover, DHOPE was safely applied with promising results in a recently performed phase-1 study. The aim of the current study is to determine the efficacy of DHOPE in reducing the incidence of NAS after DCD liver transplantation. Methods This is an international multicenter randomized controlled trial. Adult patients (≥18 yrs. old) undergoing transplantation of a DCD donor liver (Maastricht category III) will be randomized between the intervention and control group. In the intervention group, livers will be subjected to two hours of end-ischemic DHOPE after SCS and before implantation. In the control group, livers will be subjected to care as usual with conventional SCS only. Primary outcome is the incidence of symptomatic NAS diagnosed by a blinded adjudication committee. In all patients, magnetic resonance cholangiography will be obtained at six months after transplantation. Discussion DHOPE is associated with reduced IRI of the bile ducts. Whether reduced IRI of the bile ducts leads to lower incidence of NAS after DCD liver transplantation can only be examined in a randomized controlled trial. Trial registration The trial was registered in Clinicaltrials.gov in September 2015 with the identifier NCT02584283.http://link.springer.com/article/10.1186/s12876-019-0956-6Donation after circulatory deathAdultIncidenceIschemic type biliary lesionsSurvivalCost |
| spellingShingle | Rianne van Rijn Aad P. van den Berg Joris I. Erdmann Nigel Heaton Bart van Hoek Jeroen de Jonge Henri G. D. Leuvenink Shekar V. K. Mahesh Sarah Mertens Diethard Monbaliu Paolo Muiesan M. Thamara P. R. Perera Wojciech G. Polak Xavier Rogiers Roberto I. Troisi Yvonne de Vries Robert J. Porte Study protocol for a multicenter randomized controlled trial to compare the efficacy of end-ischemic dual hypothermic oxygenated machine perfusion with static cold storage in preventing non-anastomotic biliary strictures after transplantation of liver grafts donated after circulatory death: DHOPE-DCD trial BMC Gastroenterology Donation after circulatory death Adult Incidence Ischemic type biliary lesions Survival Cost |
| title | Study protocol for a multicenter randomized controlled trial to compare the efficacy of end-ischemic dual hypothermic oxygenated machine perfusion with static cold storage in preventing non-anastomotic biliary strictures after transplantation of liver grafts donated after circulatory death: DHOPE-DCD trial |
| title_full | Study protocol for a multicenter randomized controlled trial to compare the efficacy of end-ischemic dual hypothermic oxygenated machine perfusion with static cold storage in preventing non-anastomotic biliary strictures after transplantation of liver grafts donated after circulatory death: DHOPE-DCD trial |
| title_fullStr | Study protocol for a multicenter randomized controlled trial to compare the efficacy of end-ischemic dual hypothermic oxygenated machine perfusion with static cold storage in preventing non-anastomotic biliary strictures after transplantation of liver grafts donated after circulatory death: DHOPE-DCD trial |
| title_full_unstemmed | Study protocol for a multicenter randomized controlled trial to compare the efficacy of end-ischemic dual hypothermic oxygenated machine perfusion with static cold storage in preventing non-anastomotic biliary strictures after transplantation of liver grafts donated after circulatory death: DHOPE-DCD trial |
| title_short | Study protocol for a multicenter randomized controlled trial to compare the efficacy of end-ischemic dual hypothermic oxygenated machine perfusion with static cold storage in preventing non-anastomotic biliary strictures after transplantation of liver grafts donated after circulatory death: DHOPE-DCD trial |
| title_sort | study protocol for a multicenter randomized controlled trial to compare the efficacy of end ischemic dual hypothermic oxygenated machine perfusion with static cold storage in preventing non anastomotic biliary strictures after transplantation of liver grafts donated after circulatory death dhope dcd trial |
| topic | Donation after circulatory death Adult Incidence Ischemic type biliary lesions Survival Cost |
| url | http://link.springer.com/article/10.1186/s12876-019-0956-6 |
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