Jia Xuehai, Liao Anque, Huang Yang, Du Xiangyu, Jiang Li
Division of Liver Surgery, Department of General Surgery, West China Hospital of Sichuan University, Chengdu, Sichuan Province, 610041, China.
Department of Operation Center, West China Hospital/West China School of Nursing, Sichuan University, Chengdu, China.
Trials. 2025 Jun 4;26(1):194. doi: 10.1186/s13063-025-08897-5.
Among various blood flow control techniques, the intermittent Pringle's maneuver (IPM) remains the most convenient and widely used method for reducing bleeding during hepatic resection (HR). However, the impact of IPM on human hepatocellular carcinoma (HCC) recurrence is still unclear. To date, no randomized controlled trial (RCT) has directly evaluated the impact of IPM on the tumor recurrence in HCC patients undergoing HR. Since 2019, our team has been investigating the effects of 25-min IPM on liver function and post-hepatectomy safety in HCC patients. To date, we have published two RCTs that confirm the safety and feasibility of 25-min IPM for HCC patients with Child-Pugh grade A liver function. However, these studies focused exclusively on short-term outcomes and did not assess tumor recurrence. Therefore, we are designing this RCT to compare the effects of 15-min IPM with 25-min IPM on early tumor recurrence in HCC patients undergoing HR.
This will be a single-center, parallel, double-blind, randomized controlled trial. A total of 334 consecutive patients who meet the inclusion and exclusion criteria will be enrolled and randomized into either the 15-min IPM group or the 25-min IPM group in a 1:1 ratio using a randomization protocol. Patients will be followed for 2 years after surgery.
We designed this protocol to compare the effects of two different IPM methods on tumor recurrence in HCC patients undergoing HR, which will provide significant guidance for surgeons. Firstly, this study design is practical and feasible in clinical practice. Secondly, this RCT will encompass various types of HR procedures (including laparoscopic or open HR, as well as minor or major hepatectomy), ensuring a representative clinical application. Thirdly, to our knowledge, this is the first RCT to compare the effects of 15- and 25-min IPM on early recurrence of HCC.
This trial was registered on April 29, 2024, in the Chinese Clinical Trial Registry ( http://www.chictr.org.cn ), under the registration number ChiCTR2400083647. The protocol version is V1.0 (20,240,429).
在各种血流控制技术中，间歇性普林格尔手法（IPM）仍然是肝切除术中减少出血最方便且应用最广泛的方法。然而，IPM对人类肝细胞癌（HCC）复发的影响仍不清楚。迄今为止，尚无随机对照试验（RCT）直接评估IPM对接受肝切除术的HCC患者肿瘤复发的影响。自2019年以来，我们团队一直在研究25分钟IPM对HCC患者肝功能及肝切除术后安全性的影响。迄今为止，我们已发表两项RCT，证实了25分钟IPM对Child-Pugh A级肝功能的HCC患者的安全性和可行性。然而，这些研究仅关注短期结果，未评估肿瘤复发情况。因此，我们正在设计这项RCT，以比较15分钟IPM与25分钟IPM对接受肝切除术的HCC患者早期肿瘤复发的影响。
这将是一项单中心、平行、双盲、随机对照试验。总共334名符合纳入和排除标准的连续患者将被纳入研究，并使用随机化方案以1:1的比例随机分为15分钟IPM组或25分钟IPM组。患者术后将接受2年的随访。
我们设计该方案以比较两种不同的IPM方法对接受肝切除术的HCC患者肿瘤复发的影响，这将为外科医生提供重要指导。首先，本研究设计在临床实践中切实可行。其次，该RCT将涵盖各种类型的肝切除手术（包括腹腔镜或开放肝切除术，以及小范围或大范围肝切除术），确保具有代表性的临床应用。第三，据我们所知，这是第一项比较15分钟和25分钟IPM对HCC早期复发影响的RCT。
本试验于2024年4月29日在中国临床试验注册中心（http://www.chictr.org.cn）注册，注册号为ChiCTR2400083647。方案版本为V1.0（20,240,429）。
