Date: Saturday, May 30, 2020
Session Time: 3:15pm-4:45pm
Presentation Time: 4:15pm-4:27pm
*Purpose: We’ve established a novel procedure called ischemia-free liver transplantation (IFLT). The results from the pilot study suggest that IFLT might prevent ischemia-reperfusion injury (IRI) and yield better transplant outcomes in comparison to conventional liver transplantation (CLT). The purpose of this study was to further explore the efficacy and safety of IFLT in a prospective, randomized, controlled trial.
*Methods: This is an investigator initiated, open-label, phase-III, prospective, single-center randomized, controlled trial on the effects of IFLT in patients with end-stage liver disease. The primary endpoint is the incidence of early allograft dysfuncion (EAD) after liver transplantation. After 12-month follow-up of the last enrolled recipient, the outcomes will be analyzed to evaluate the safety and efficacy of IFLT versus CLT in patients with end-stage liver disease. We aimed to recruit 34 cases in each arm.
*Results: By December 1st, 2019, a total of 25 patients have been enrolled in the trial (12 in CLT group and 13 in IFLT group). The perfusion parameters and blood gas results showed that the perfusion remained stable and the livers functioned well during IFLT procedures. Of the 13 patients in the IFLT group, 1 (7.7%) suffered from EAD and 0 suffered from PNF, and compared with 3 (25%) suffered from EAD and 1 suffered from primary non-function (PNF) in the CLT group. No recipient died in the IFLT group, while one died from PNF in the CLT group. Besides, the IFLT group was associated with less liver graft injuries [peak aspartate aminotransferase levels, 532.92 (205-1484) versus 1382.55 (232-4260) U/L, P = 0.0283; peak alanine aminotransferase levels, 195.31 (93-437) versus 492.73 (105-1330) U/L, P = 0.0343]. The total bilirubin level on postoperative day 7 in the IFLT group was 2.64 (0.63-11.64) mg/dL compared with 4.90 (0.99-15.44) mg/dL in the CLT group (P= 0.1463). The pre-albumin level on postoperative day 7 in the IFLT group was 171.38 ± 39.81 mg/L compared with 148.91 ± 38.51 mg/L in the CLT group (P = 0.1758 ). The gamma-glutamyl transpeptidase level on postoperative day 7 in the IFLT group was 184.23 (29-465) U/L compared with 220.73 (59-476) U/L in the CLT group (P= 0.5068).
*Conclusions: The preliminary results of our trial suggests that IFLT is reliable and provides a novel approach to minimize graft IRI. The final results of this first randomized trial are pending.
To cite this abstract in AMA style:He X, Guo Z, Zhao Q, Huang C, Ju W, Wang D, Chen M, Wu L, Ma Y, Chen Y, Hu A, Zhu X. The Efficacy and Safety of Ischemia-Free Liver Transplantation (IFLT) in the Treatment of End-Stage Liver Disease in a Prospective, Randomized, Controlled Trial: A Report of the First 25 Cases [abstract]. Am J Transplant. 2020; 20 (suppl 3). https://atcmeetingabstracts.com/abstract/the-efficacy-and-safety-of-ischemia-free-liver-transplantation-iflt-in-the-treatment-of-end-stage-liver-disease-in-a-prospective-randomized-controlled-trial-a-report-of-the-first-25-cases/. Accessed October 22, 2020.
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