General and Liver Transplant Surgery, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy.
General Surgery, Fondazione Policlinico Universitario Campus Bio-Medico, Rome, Italy.
BMJ Open. 2022 Aug 1;12(8):e063081. doi: 10.1136/bmjopen-2022-063081.
Viability assessment of the graft is essential to lower the risk of liver transplantation (LT) failure and need for emergency retransplantation, however, this still relies mainly on surgeon's experience. Post-LT graft function recovery assessment is also essential to aid physicians in the management of LT recipients and guide them through challenging decision making.This study aims to trial the use of indocyanine green clearance test (IGT) in the donor as an objective tool to assess graft viability and in the recipient to assess graft function recovery after LT.
This is an observational prospective single-centre study on consecutive liver transplant donors and recipients.
To determine the capability of IGT of predicting graft viability at the time of organ retrieval. Indocyanine green will be administered to the donor and the plasma disappearance rate (PDR) measured using the pulsidensitometric method. Some 162 IGT donor procedures will be required (α, 5%; β, 20%) using an IGT-PDR cut-off value of 13% to achieve a significant discrimination between viable and non-viable grafts.
IGT-PDR will be measured at different time-points in the LT recipient: during the anhepatic phase, after graft reperfusion, at 24 hours, on day 3 and day 7 after LT. The slope of IGT values from the donor to the recipient will be evaluated for correlation with the development of early allograft dysfunction.
This research protocol was approved by Fondazione Policlinico Universitario Agostino Gemelli IRCCS Ethics Committee (reference number: 0048466/20, study ID: 3656) and by the Italian National Transplant Center (CNT) (reference number: Prot.11/CNT2021). Liver recipients will be required to provide written informed consent. Results will be published in international peer-reviewed scientific journals and presented in congresses.
NCT05228587.
评估移植物的活力对于降低肝移植（LT）失败和需要紧急再次移植的风险至关重要，但这仍然主要依赖于外科医生的经验。LT 后移植物功能恢复的评估对于帮助医生管理 LT 受者以及指导他们进行具有挑战性的决策也很重要。本研究旨在尝试使用吲哚菁绿清除试验（IGT）在供体中作为评估供体移植物活力的客观工具，并在受体中评估 LT 后移植物功能恢复。
这是一项连续肝移植供体和受体的观察性前瞻性单中心研究。
确定 IGT 在器官获取时预测移植物活力的能力。将吲哚菁绿施用于供体，并使用脉冲密度法测量血浆消失率（PDR）。需要进行大约 162 次 IGT 供体程序（α，5%；β，20%），使用 IGT-PDR 截止值 13%来实现对有活力和无活力移植物的显著区分。
在 LT 受者的不同时间点测量 IGT-PDR：在无肝期、移植物再灌注后、24 小时、LT 后 3 天和 7 天。将从供体到受体的 IGT 值的斜率评估与早期同种异体移植功能障碍的发展相关。
本研究方案已获得 Fondazione Policlinico Universitario Agostino Gemelli IRCCS 伦理委员会（参考编号：0048466/20，研究 ID：3656）和意大利国家移植中心（CNT）（参考编号：Prot.11/CNT2021）的批准。肝受体将需要提供书面知情同意书。结果将发表在国际同行评议的科学期刊上，并在会议上展示。
NCT05228587。
