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

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

doi:10.1186/s12876-019-0956-6

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

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^*

^*Corresponding author for this work

Groningen Institute for Organ Transplantation (GIOT)

Research output: Contribution to journal › Article › Academic › peer-review

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Abstract

BackgroundThe 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.MethodsThis is an international multicenter randomized controlled trial. Adult patients (18yrs. 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.DiscussionDHOPE 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 registrationThe trial was registered in Clinicaltrials.gov in September 2015 with the identifier NCT02584283.

Original language	English
Article number	40
Number of pages	12
Journal	Bmc gastroenterology
Volume	19
DOIs	https://doi.org/10.1186/s12876-019-0956-6
Publication status	Published - 12-Mar-2019

Keywords

Donation after circulatory death
Adult
Incidence
Ischemic type biliary lesions
Survival
Cost
CARDIAC DEATH
BILE-DUCTS
RAT-LIVER
PRESERVATION
COMPLICATIONS
DONORS
DYSFUNCTION
CRITERIA
OUTCOMES
INJURY

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van Rijn, R., van den Berg, A. P., Erdmann, J. I., Heaton, N., van Hoek, B., de Jonge, J., Leuvenink, H. G. D., Mahesh, S. V. K., Mertens, S., Monbaliu, D., Muiesan, P., Perera, M. T. P. R., Polak, W. G., Rogiers, X., Troisi, R. I., de Vries, Y., & Porte, R. J. (2019). 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, 19, Article 40. https://doi.org/10.1186/s12876-019-0956-6

van Rijn, Rianne ; van den Berg, Aad P. ; Erdmann, Joris I. et al. / 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. In: Bmc gastroenterology. 2019 ; Vol. 19.

@article{15318fc82fbf4d719f3a233ff3d387c0,

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",

abstract = "BackgroundThe 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.MethodsThis is an international multicenter randomized controlled trial. Adult patients (18yrs. 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.DiscussionDHOPE 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 registrationThe trial was registered in Clinicaltrials.gov in September 2015 with the identifier NCT02584283.",

keywords = "Donation after circulatory death, Adult, Incidence, Ischemic type biliary lesions, Survival, Cost, CARDIAC DEATH, BILE-DUCTS, RAT-LIVER, PRESERVATION, COMPLICATIONS, DONORS, DYSFUNCTION, CRITERIA, OUTCOMES, INJURY",

author = "{van Rijn}, Rianne and {van den Berg}, {Aad P.} and Erdmann, {Joris I.} and Nigel Heaton and {van Hoek}, Bart and {de Jonge}, Jeroen and Leuvenink, {Henri G. D.} and Mahesh, {Shekar V. K.} and Sarah Mertens and Diethard Monbaliu and Paolo Muiesan and Perera, {M. Thamara P. R.} and Polak, {Wojciech G.} and Xavier Rogiers and Troisi, {Roberto I.} and {de Vries}, Yvonne and Porte, {Robert J.}",

year = "2019",

month = mar,

day = "12",

doi = "10.1186/s12876-019-0956-6",

language = "English",

volume = "19",

journal = "Bmc gastroenterology",

issn = "1471-230X",

publisher = "BMC",

}

van Rijn, R, van den Berg, AP, Erdmann, JI, Heaton, N, van Hoek, B, de Jonge, J, Leuvenink, HGD , Mahesh, SVK, Mertens, S, Monbaliu, D, Muiesan, P, Perera, MTPR, Polak, WG, Rogiers, X, Troisi, RI, de Vries, Y & Porte, RJ 2019, '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, vol. 19, 40. https://doi.org/10.1186/s12876-019-0956-6

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. / van Rijn, Rianne; van den Berg, Aad P.; Erdmann, Joris I. et al.
In: Bmc gastroenterology, Vol. 19, 40, 12.03.2019.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - 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

T2 - DHOPE-DCD trial

AU - van Rijn, Rianne

AU - van den Berg, Aad P.

AU - Erdmann, Joris I.

AU - Heaton, Nigel

AU - van Hoek, Bart

AU - de Jonge, Jeroen

AU - Leuvenink, Henri G. D.

AU - Mahesh, Shekar V. K.

AU - Mertens, Sarah

AU - Monbaliu, Diethard

AU - Muiesan, Paolo

AU - Perera, M. Thamara P. R.

AU - Polak, Wojciech G.

AU - Rogiers, Xavier

AU - Troisi, Roberto I.

AU - de Vries, Yvonne

AU - Porte, Robert J.

PY - 2019/3/12

Y1 - 2019/3/12

N2 - BackgroundThe 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.MethodsThis is an international multicenter randomized controlled trial. Adult patients (18yrs. 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.DiscussionDHOPE 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 registrationThe trial was registered in Clinicaltrials.gov in September 2015 with the identifier NCT02584283.

AB - BackgroundThe 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.MethodsThis is an international multicenter randomized controlled trial. Adult patients (18yrs. 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.DiscussionDHOPE 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 registrationThe trial was registered in Clinicaltrials.gov in September 2015 with the identifier NCT02584283.

KW - Donation after circulatory death

KW - Adult

KW - Incidence

KW - Ischemic type biliary lesions

KW - Survival

KW - Cost

KW - CARDIAC DEATH

KW - BILE-DUCTS

KW - RAT-LIVER

KW - PRESERVATION

KW - COMPLICATIONS

KW - DONORS

KW - DYSFUNCTION

KW - CRITERIA

KW - OUTCOMES

KW - INJURY

U2 - 10.1186/s12876-019-0956-6

DO - 10.1186/s12876-019-0956-6

M3 - Article

SN - 1471-230X

VL - 19

JO - Bmc gastroenterology

JF - Bmc gastroenterology

M1 - 40

ER -

van Rijn R, van den Berg AP, Erdmann JI, Heaton N, van Hoek B, de Jonge J et al. 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. 2019 Mar 12;19:40. doi: 10.1186/s12876-019-0956-6