Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.
Collaborative Innovation Center for Cancer Medicine, State Key Laboratory of Oncology in South China, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China; Department of Anesthesiology, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, P.R. China.
Surgery. 2020 Jun;167(6):933-941. doi: 10.1016/j.surg.2020.02.004. Epub 2020 Mar 23.
Excessive intraoperative hemorrhage is a critical factor of poor prognoses after hepatectomy. Low central venous pressure during parenchymal transection is recognized to effectively reduce intraoperative hemorrhage in open procedures. However, the role of controlled low central venous pressure in laparoscopic hepatectomy is still controversial.
In the present randomized clinical trial, we set up a standard boundary of low central venous pressure according to our Pilot Study, then enrolled patients scheduled for elective laparoscopic hepatectomy and allocated them randomly to a group undergoing central venous pressure reduction by anesthesiologic interventions or a control group. The primary efficacy endpoint was total intraoperative blood loss and perioperative adverse events. Analyses were performed following the intention-to-treat principle, and patients and surgeons were blinded (ClinicalTrials.gov, Number: NCT03422913).
Between January 2017 and October 2018, 146 out of 469 patients were randomized and eligible for inclusion in the final analyses. Based on the retrospective training cohort, we set a central venous pressure of 5 cm HO as a cutoff value (standard low central venous pressure). Compared with patients in the control group, those in the controlled low central venous pressure group had a significantly lower central venous pressure during resection (4.83 ± 3.41 cm HO vs 9.26 ± 3.38 cm HO; P < .001) and significantly reduced total intraoperative blood loss (188.00 ± 162.00 mL vs 346.00 ± 336.00 mL; P < .001). The perioperative adverse events were comparable in both study groups (P = .313).
The safety and efficacy of controlled low central venous pressure were demonstrated in complex laparoscopic hepatectomy for the first time by our study, and this technique is recommended to be applied routinely in laparoscopic hepatectomy.
术中大量出血是肝切除术后预后不良的关键因素。肝实质离断时采用较低的中心静脉压被认为可有效减少开腹手术中的术中出血。然而，在腹腔镜肝切除术中控制较低中心静脉压的作用仍存在争议。
在本随机临床试验中，我们根据预试验设定了一个标准的低中心静脉压边界，然后招募了择期行腹腔镜肝切除术的患者，并将其随机分配到接受麻醉干预降低中心静脉压的组或对照组。主要疗效终点是总术中失血量和围手术期不良事件。分析采用意向治疗原则，患者和外科医生均设盲（ClinicalTrials.gov，编号：NCT03422913）。
2017 年 1 月至 2018 年 10 月，469 例患者中有 146 例被随机分组且符合最终分析纳入标准。基于回顾性训练队列，我们将中心静脉压 5cmH2O 设定为截断值（标准低中心静脉压）。与对照组患者相比，控制性低中心静脉压组在切除期间的中心静脉压显著降低（4.83±3.41cmH2O 比 9.26±3.38cmH2O；P<0.001），总术中失血量也显著减少（188.00±162.00mL 比 346.00±336.00mL；P<0.001）。两组的围手术期不良事件发生率无差异（P=0.313）。
本研究首次证明了控制性低中心静脉压在复杂腹腔镜肝切除术中的安全性和有效性，建议将该技术常规应用于腹腔镜肝切除术。
