In patients undergoing major liver resection, portal vein embolization (PVE) has been widely used to induce hypertrophy of the non-embolized liver in order to prevent post-hepatectomy liver failure. PVE is a safe and effective procedure, but does not always lead to sufficient hypertrophy of the future liver remnant (FLR). Hepatic vein(s) embolization has been proposed to improve FLR regeneration when insufficient after PVE. The sequential right hepatic vein embolization (HVE) after right PVE demonstrated an incremental effect on the FLR but it implies two different procedures with no time gain as compared to PVE alone. We have developed the so-called liver venous deprivation (LVD), a combination of PVE and HVE during the same intervention, to optimize the phase of liver preparation before surgery. The main objective of this randomized phase II trial is to compare the percentage of change in FLR volume at 3 weeks after LVD or PVE. Patients eligible to this multicenter prospective randomized phase II study are subjects aged from 18 years old suffering from colo-rectal liver metastases considered as resectable and with non-cirrhotic liver parenchyma. The primary objective is the percentage of change in FLR volume at 3 weeks after LVD or PVE using MRI or CT-Scan. Secondary objectives are assessment of tolerance, post-operative morbidity and mortality, post-hepatectomy liver failure, rate of non-respectability due to insufficient FLR or tumor progression, per-operative difficulties, blood loss, R0 resection rate, post-operative liver volume and overall survival. Objectives of translational research studies are evaluation of pre- and post-operative liver function and determination of biomarkers predictive of liver hypertrophy. Sixty-four patients will be included (randomization ratio 1:1) to detect a difference of 12% at 21 days in FLR volumes between PVE and LVD. Adding HVE to PVE during the same procedure is an innovative and promising approach that may lead to a rapid and major increase in volume and function of the FLR, thereby increasing the rate of resectable patients and limiting the risk of patient’s drop-out. This study was registered on on 15th February 2019 (NCT03841305).

中文翻译：

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HYPER-LIV01 试验的研究方案：一项多中心 II 期前瞻性随机研究，比较同时门静脉和肝静脉栓塞与门静脉栓塞治疗结直肠肝转移的主要肝切除术前未来肝脏残余肥大的情况。


在接受主要肝切除术的患者中，门静脉栓塞（PVE）已被广泛用于诱导非栓塞肝脏肥大，以预防肝切除术后肝功能衰竭。 PVE 是一种安全有效的手术，但并不总能导致未来肝脏残余物 (FLR) 充分肥大。当 PVE 后 FLR 再生不足时，已提出肝静脉栓塞以改善 FLR 再生。右 PVE 后序贯右肝静脉栓塞 (HVE) 证明对 FLR 具有增量作用，但它意味着与单独 PVE 相比，两种不同的手术没有时间增益。我们开发了所谓的肝静脉剥夺 (LVD)，即在同一干预期间结合 PVE 和 HVE，以优化手术前的肝脏准备阶段。这项随机 II 期试验的主要目的是比较 LVD 或 PVE 后 3 周时 FLR 体积的变化百分比。符合这项多中心前瞻性随机 II 期研究资格的患者是 18 岁以上患有结直肠肝转移且被认为可切除且肝实质非肝硬化的受试者。主要目标是 LVD 或 PVE 后 3 周时使用 MRI 或 CT 扫描得出的 FLR 体积变化百分比。次要目标是评估耐受性、术后发病率和死亡率、肝切除术后肝功能衰竭、由于 FLR 不足或肿瘤进展而导致的不尊重率、术中困难、失血量、R0 切除率、术后肝脏体积和总体生存率。转化研究的目的是评估术前和术后肝功能以及确定预测肝肥大的生物标志物。 将纳入 64 名患者（随机化比例 1:1），以检测 PVE 和 LVD 之间 21 天时 FLR 体积的 12% 差异。在同一手术中将 HVE 添加到 PVE 是一种创新且有前途的方法，可能会导致 FLR 的体积和功能快速大幅增加，从而提高患者的可切除率并限制患者退出的风险。这项研究于 2019 年 2 月 15 日注册（NCT03841305）。