肝移植中直接腹膜复苏的可行性和安全性的 I 期临床试验。
Phase I clinical trial of the feasibility and safety of direct peritoneal resuscitation in liver transplantation.
机构信息
Colorado Center for Transplantation Care, Research, and Education (CCTCARE), Department of Surgery, University of Colorado Anschutz Medical Campus, Aurora, CO, USA; Department of Surgery, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Department of Surgery, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
出版信息
Am J Surg. 2024 Dec;238:115815. doi: 10.1016/j.amjsurg.2024.115815. Epub 2024 Jul 2.
BACKGROUND
Direct peritoneal resuscitation (DPR) is associated with improved outcomes in trauma. Animal models suggest DPR has favorable effects on the liver. We sought to evaluate its safety and assess for improved outcomes in liver transplantation (LT).
METHODS
LT patients with renal dysfunction and/or obesity were enrolled in a phase-I clinical trial. DPR lasted 8-24 h depending on postoperative disposition. Primary outcome was percent of patients completing DPR. Secondary outcomes evaluated complications. Controls with either obesity (control-1) or both risk factors (obesity + renal dysfunction, control-2) were analyzed.
RESULTS
Fifteen patients were enrolled (seven with both criteria and eight with obesity alone). DPR was completed in 87 % of patients, with one meeting stopping criteria. Controls included 45 (control-1) and 24 (control-2) patients. Return to operating room, graft loss, and late infections were lower with DPR.
CONCLUSION
DPR appears to be safe in closed abdomens following LT, warranting a follow-up phase-II trial to assess efficacy.
背景
直接腹膜复苏（DPR）与创伤后改善结果相关。动物模型表明 DPR 对肝脏有有利影响。我们试图评估其安全性并评估在肝移植（LT）中的改善结果。
方法
LT 患者伴有肾功能障碍和/或肥胖症，参加了一项 I 期临床试验。DPR 的持续时间取决于术后处置，为 8-24 小时。主要结果是完成 DPR 的患者比例。次要结果评估并发症。分别分析仅肥胖（对照 1）或两个危险因素（肥胖症+肾功能障碍，对照 2）的对照患者。
结果
共纳入 15 例患者（7 例符合两项标准，8 例仅肥胖）。87%的患者完成了 DPR，有 1 例符合停止标准。对照组包括 45 例（对照 1）和 24 例（对照 2）患者。DPR 后返回手术室、移植物丢失和晚期感染的发生率较低。
结论
DPR 在 LT 后封闭腹部中似乎是安全的，值得进行后续 II 期试验以评估疗效。
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