The Effect of Remote Ischemic Preconditioning in Living Donor Hepatectomy
NCT ID: NCT03386435
Last Updated: 2019-08-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
160 participants
INTERVENTIONAL
2016-08-22
2017-10-30
Brief Summary
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Detailed Description
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IRI occurs when the blood supply to an organ or tissue is temporarily cut-off and then restored, and it is well-known as an underlying cause of primary non-function, biliary complications, and eventual graft loss after LT. Despite many attempts to ameliorate hepatic IRI, no definitive therapies have been established. In addition, the mechanisms of IRI remain largely unclear.
Remote ischemic preconditioning (RIPC) is a novel and simple therapeutic method to lessen the harmful effects of IRI. RIPC indicate that brief episodes of ischemia with intermittent reperfusion are introduced at a remote site, leading to systemic protection against subsequent insults as evinced on kidney, heart, liver, and other tissues. While RIPC has been shown to reduce hepatic IRI in several small animal studies, the beneficial effects of RIPC in hepatic IRI have been inconsistent. By far, the majority of RIPC studies on hepatic IRI have been animal studies; hence, there are limitations relating to the lack of human clinical trials.
Therefore, our aim was to assess the effects of RIPC on postoperative liver function in living donor hepatectomy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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RIPC
intervention: RIPC groups receive remote ischaemic preconditioning after anaesthesia induction and before surgery started.
remote ischemic preconditioning
Remote ischemic preconditioning was performed following anesthesia induction in donors. The protocol involves 3 cycles of 5-minute inflation of a blood pressure cuff to 200 mm Hg to one upper arm, followed by 5-minute reperfusion with the cuff deflated
Control
In the control group, the same maneuver was applied but without cuff inflation.
No interventions assigned to this group
Interventions
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remote ischemic preconditioning
Remote ischemic preconditioning was performed following anesthesia induction in donors. The protocol involves 3 cycles of 5-minute inflation of a blood pressure cuff to 200 mm Hg to one upper arm, followed by 5-minute reperfusion with the cuff deflated
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age : between 18 to 60 years.
Exclusion Criteria
* donors who plan to have laparoscopic right hepatectomy
* donors who cannot proceed remote ischemic preconditioning
18 Years
60 Years
ALL
No
Sponsors
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Asan Medical Center
OTHER
Responsible Party
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Jun-Gol Song
Associate Professor
Principal Investigators
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Jun-Gol Song, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Asan medical center
Seoul, Songpa-gu, South Korea
Countries
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References
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Foley DP, Fernandez LA, Leverson G, Chin LT, Krieger N, Cooper JT, Shames BD, Becker YT, Odorico JS, Knechtle SJ, Sollinger HW, Kalayoglu M, D'Alessandro AM. Donation after cardiac death: the University of Wisconsin experience with liver transplantation. Ann Surg. 2005 Nov;242(5):724-31. doi: 10.1097/01.sla.0000186178.07110.92.
Karp SJ, Johnson S, Evenson A, Curry MP, Manning D, Malik R, Lake-Bakaar G, Lai M, Hanto D. Minimising cold ischaemic time is essential in cardiac death donor-associated liver transplantation. HPB (Oxford). 2011 Jun;13(6):411-6. doi: 10.1111/j.1477-2574.2011.00307.x. Epub 2011 Apr 4.
Halladin NL. Oxidative and inflammatory biomarkers of ischemia and reperfusion injuries. Dan Med J. 2015 Apr;62(4):B5054.
Abu-Amara M, Yang SY, Quaglia A, Rowley P, Tapuria N, Seifalian AM, Fuller BJ, Davidson BR. Effect of remote ischemic preconditioning on liver ischemia/reperfusion injury using a new mouse model. Liver Transpl. 2011 Jan;17(1):70-82. doi: 10.1002/lt.22204.
Abu-Amara M, Yang SY, Quaglia A, Rowley P, de Mel A, Tapuria N, Seifalian A, Davidson B, Fuller B. Nitric oxide is an essential mediator of the protective effects of remote ischaemic preconditioning in a mouse model of liver ischaemia/reperfusion injury. Clin Sci (Lond). 2011 Sep;121(6):257-66. doi: 10.1042/CS20100598.
Gill R, Kuriakose R, Gertz ZM, Salloum FN, Xi L, Kukreja RC. Remote ischemic preconditioning for myocardial protection: update on mechanisms and clinical relevance. Mol Cell Biochem. 2015 Apr;402(1-2):41-9. doi: 10.1007/s11010-014-2312-z. Epub 2015 Jan 1.
Bjornsson B, Winbladh A, Bojmar L, Sundqvist T, Gullstrand P, Sandstrom P. Conventional, but not remote ischemic preconditioning, reduces iNOS transcription in liver ischemia/reperfusion. World J Gastroenterol. 2014 Jul 28;20(28):9506-12. doi: 10.3748/wjg.v20.i28.9506.
Hwang S, Lee SG, Lee YJ, Sung KB, Park KM, Kim KH, Ahn CS, Moon DB, Hwang GS, Kim KM, Ha TY, Kim DS, Jung JP, Song GW. Lessons learned from 1,000 living donor liver transplantations in a single center: how to make living donations safe. Liver Transpl. 2006 Jun;12(6):920-7. doi: 10.1002/lt.20734.
Jung KW, Kim WJ, Jeong HW, Kwon HM, Moon YJ, Jun IG, Song JG, Hwang GS. Impact of Inhalational Anesthetics on Liver Regeneration After Living Donor Hepatectomy: A Propensity Score-Matched Analysis. Anesth Analg. 2018 Mar;126(3):796-804. doi: 10.1213/ANE.0000000000002756.
Kim YK, Shin WJ, Song JG, Jun IG, Kim HY, Seong SH, Huh IY, Hwang GS. Effect of right ventricular dysfunction on dynamic preload indices to predict a decrease in cardiac output after inferior vena cava clamping during liver transplantation. Transplant Proc. 2010 Sep;42(7):2585-9. doi: 10.1016/j.transproceed.2010.04.041.
Rahbari NN, Garden OJ, Padbury R, Brooke-Smith M, Crawford M, Adam R, Koch M, Makuuchi M, Dematteo RP, Christophi C, Banting S, Usatoff V, Nagino M, Maddern G, Hugh TJ, Vauthey JN, Greig P, Rees M, Yokoyama Y, Fan ST, Nimura Y, Figueras J, Capussotti L, Buchler MW, Weitz J. Posthepatectomy liver failure: a definition and grading by the International Study Group of Liver Surgery (ISGLS). Surgery. 2011 May;149(5):713-24. doi: 10.1016/j.surg.2010.10.001. Epub 2011 Jan 14.
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Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.
Przyklenk K, Bauer B, Ovize M, Kloner RA, Whittaker P. Regional ischemic 'preconditioning' protects remote virgin myocardium from subsequent sustained coronary occlusion. Circulation. 1993 Mar;87(3):893-9. doi: 10.1161/01.cir.87.3.893.
Hausenloy DJ, Erik Botker H, Condorelli G, Ferdinandy P, Garcia-Dorado D, Heusch G, Lecour S, van Laake LW, Madonna R, Ruiz-Meana M, Schulz R, Sluijter JP, Yellon DM, Ovize M. Translating cardioprotection for patient benefit: position paper from the Working Group of Cellular Biology of the Heart of the European Society of Cardiology. Cardiovasc Res. 2013 Apr 1;98(1):7-27. doi: 10.1093/cvr/cvt004. Epub 2013 Jan 19.
Robertson FP, Magill LJ, Wright GP, Fuller B, Davidson BR. A systematic review and meta-analysis of donor ischaemic preconditioning in liver transplantation. Transpl Int. 2016 Nov;29(11):1147-1154. doi: 10.1111/tri.12849. Epub 2016 Sep 20.
Imamura H, Kokudo N, Sugawara Y, Sano K, Kaneko J, Takayama T, Makuuchi M. Pringle's maneuver and selective inflow occlusion in living donor liver hepatectomy. Liver Transpl. 2004 Jun;10(6):771-8. doi: 10.1002/lt.20158.
Man K, Fan ST, Ng IO, Lo CM, Liu CL, Yu WC, Wong J. Tolerance of the liver to intermittent pringle maneuver in hepatectomy for liver tumors. Arch Surg. 1999 May;134(5):533-9. doi: 10.1001/archsurg.134.5.533.
Robertson FP, Fuller BJ, Davidson BR. An Evaluation of Ischaemic Preconditioning as a Method of Reducing Ischaemia Reperfusion Injury in Liver Surgery and Transplantation. J Clin Med. 2017 Jul 14;6(7):69. doi: 10.3390/jcm6070069.
Kanoria S, Jalan R, Seifalian AM, Williams R, Davidson BR. Protocols and mechanisms for remote ischemic preconditioning: a novel method for reducing ischemia reperfusion injury. Transplantation. 2007 Aug 27;84(4):445-58. doi: 10.1097/01.tp.0000228235.55419.e8.
Kanoria S, Robertson FP, Mehta NN, Fusai G, Sharma D, Davidson BR. Effect of Remote Ischaemic Preconditioning on Liver Injury in Patients Undergoing Major Hepatectomy for Colorectal Liver Metastasis: A Pilot Randomised Controlled Feasibility Trial. World J Surg. 2017 May;41(5):1322-1330. doi: 10.1007/s00268-016-3823-4.
Amador A, Grande L, Marti J, Deulofeu R, Miquel R, Sola A, Rodriguez-Laiz G, Ferrer J, Fondevila C, Charco R, Fuster J, Hotter G, Garcia-Valdecasas JC. Ischemic pre-conditioning in deceased donor liver transplantation: a prospective randomized clinical trial. Am J Transplant. 2007 Sep;7(9):2180-9. doi: 10.1111/j.1600-6143.2007.01914.x.
Franchello A, Gilbo N, David E, Ricchiuti A, Romagnoli R, Cerutti E, Salizzoni M. Ischemic preconditioning (IP) of the liver as a safe and protective technique against ischemia/reperfusion injury (IRI). Am J Transplant. 2009 Jul;9(7):1629-39. doi: 10.1111/j.1600-6143.2009.02680.x. Epub 2009 Jun 10.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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RIPC_donor
Identifier Type: -
Identifier Source: org_study_id
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