The efficacy and safety of ischemia-free liver transplantation versus conventional liver transplantation in the treatment of end-stage liver diseases: A single-centre randomised controlled trial

Conditions

End-stage liver disease

Guo Z, Zhao Q, Jia Z, Huang C, Wang D, Ju W, Zhang J, Yang L, Huang S, Chen M, Zhu X, Hu A, Ma Y, Wu L, Chen Y, Han M, Tang Y, Wang G, Wang L, Li L, Xiong W, Zhang Z, Shen Y, Tang Z, Zhu C, Chen X, Hu X, Guo Y, Chen H, Ma Y, Zhang T, Huang S, Zeng P, Lai S, Wang T, Chen Z, Gong J, Yu J, Sun C, Li C, Tan H, Liu Y, Dong Y, Sun C, Liao B, Ren J, Zhou Z, Andrea S, Björn N, Cai C, Gong F, Rong J, Huang W, Guan X, Clavien PA, Stefan TG, Huang J, He X.

2023-04-2076 citations

10.1016/j.jhep.2023.04.010

Prospective, single-centre, randomised controlled trial to evaluate the efficacy and safety of ischaemia-free liver transplantation (IFLT) in the treatment of end-stage liver disease

Changjun Huang, Shanzhou� Huang, Yunhua Tang, Qiang Zhao, Dongping Wang et al. (26 authors)

BMJ Open2020-05-0118 citations

10.1136/bmjopen-2019-035374

Interventions

Experimental group:Ischemia-free liver transplantation

Control group:Conventional liver transplantation

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Donor Inclusion Criteria 1. Liver allografts from donation after brain death (DBD); 2. Donors over the age of 18 years , or over the age of 14 years with body weight > 50kg; 3. Donor livers allocated to the recipients at the same center. Recipient Inclusion Criteria: 1.Adult patients (18-75 years old ) 2.Active on the waiting list for liver transplantation 3.Receive liver allografts from deceased donors 4.Able to give informed consent 5.Willing to follow the study protocol

Exclusion criteria

Exclusion criteria: Donor Exclusion Criteria: 1. Liver intended for split transplant; 2. With high-risk infectious disease such as human immunodeficiency virus infection and active tuberculosis; 3. Diagnosed of cancers with risk of transmission higher than 10% according to DTAC recommendation. Recipient Exclusion Criteria: 1.Transplantation of more than one organ (e.g. combined liver and kidney transplantation) 2.ABO blood group incompatible 3.With liver cancer beyond the UCSF criteria 4.With fulminant liver failure 5.Women during pregnancy 6.History of organ transplantation 7.With contraindications according to AASLD guideline (Except MELD score <15)

Design outcomes

Primary

Measure	Time frame
Early allograft dysfunction;	—

Secondary

Measure	Time frame
Peak alanine aminotransferase(ALT) post-transplantation;Peak aspartate transaminase(AST) post-transplantation;Total Bilirubin on day 7 post-transplantation;International Normalized Ratio (INR) on day 7 post-transplantation;Serum bilirubin, ALT, AST, gamma-glutamyl transpeptidase (GGT), alkaline phosphatase (ALP) and INR;Arterial lactate after reperfusion;Primary non-function (PNF);Post-reperfusion syndrome;Biliary complication and ischemic-type biliary lesion post-transplantation;Patient survival;Graft survival;Length of stay in Intensive Care Unit (ICU);Length of hospital stay;Allograft rejection;Vascular complications;Acute kidney injury;Estimated glomerular filtration rate (eGFR);Need for renal replacement therapy;Recipient infection;Cumulative postoperative complications;Adverse event and serious adverse event incidence;Positive microbial culture of perfusate;Organ discard rate;	—

Measure

Time frame

Peak alanine aminotransferase(ALT) post-transplantation;Peak aspartate transaminase(AST) post-transplantation;Total Bilirubin on day 7 post-transplantation;International Normalized Ratio (INR) on day 7 post-transplantation;Serum bilirubin, ALT, AST, gamma-glutamyl transpeptidase (GGT), alkaline phosphatase (ALP) and INR;Arterial lactate after reperfusion;Primary non-function (PNF);Post-reperfusion syndrome;Biliary complication and ischemic-type biliary lesion post-transplantation;Patient survival;Graft survival;Length of stay in Intensive Care Unit (ICU);Length of hospital stay;Allograft rejection;Vascular complications;Acute kidney injury;Estimated glomerular filtration rate (eGFR);Need for renal replacement therapy;Recipient infection;Cumulative postoperative complications;Adverse event and serious adverse event incidence;Positive microbial culture of perfusate;Organ discard rate;

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Countries

China

Contacts

Public ContactXiaoshun He

The First Affiliated Hospital, Sun Yat-sen University

gdtrc@163.com+86 13802510799

Outcome results

None listed