The Intervention Center, Oslo University Hospital, Oslo, Norway.
Department of Hepato-Pancreato-Biliary Surgery, Oslo University Hospital, Oslo, Norway.
Ann Surg. 2018 Feb;267(2):199-207. doi: 10.1097/SLA.0000000000002353.
To perform the first randomized controlled trial to compare laparoscopic and open liver resection.
Laparoscopic liver resection is increasingly used for the surgical treatment of liver tumors. However, high-level evidence to conclude that laparoscopic liver resection is superior to open liver resection is lacking.
Explanatory, assessor-blinded, single center, randomized superiority trial recruiting patients from Oslo University Hospital, Oslo, Norway from February 2012 to January 2016. A total of 280 patients with resectable liver metastases from colorectal cancer were randomly assigned to undergo laparoscopic (n = 133) or open (n = 147) parenchyma-sparing liver resection. The primary outcome was postoperative complications within 30 days (Accordion grade 2 or higher). Secondary outcomes included cost-effectiveness, postoperative hospital stay, blood loss, operation time, and resection margins.
The postoperative complication rate was 19% in the laparoscopic-surgery group and 31% in the open-surgery group (12 percentage points difference [95% confidence interval 1.67-21.8; P = 0.021]). The postoperative hospital stay was shorter for laparoscopic surgery (53 vs 96 hours, P < 0.001), whereas there were no differences in blood loss, operation time, and resection margins. Mortality at 90 days did not differ significantly from the laparoscopic group (0 patients) to the open group (1 patient). In a 4-month perspective, the costs were equal, whereas patients in the laparoscopic-surgery group gained 0.011 quality-adjusted life years compared to patients in the open-surgery group (P = 0.001).
In patients undergoing parenchyma-sparing liver resection for colorectal metastases, laparoscopic surgery was associated with significantly less postoperative complications compared to open surgery. Laparoscopic resection was cost-effective compared to open resection with a 67% probability. The rate of free resection margins was the same in both groups. Our results support the continued implementation of laparoscopic liver resection.
进行首次随机对照试验以比较腹腔镜和开腹肝切除术。
腹腔镜肝切除术越来越多地用于肝肿瘤的外科治疗。然而，缺乏高级别的证据来得出腹腔镜肝切除术优于开腹肝切除术的结论。
解释性、评估者盲法、单中心、随机优势试验，于 2012 年 2 月至 2016 年 1 月在挪威奥斯陆大学医院招募患者。共有 280 例结直肠癌可切除肝转移患者被随机分配接受腹腔镜（n = 133）或开腹（n = 147）实质保留肝切除术。主要结局是术后 30 天内的并发症（Accordion 分级 2 级或更高）。次要结局包括成本效益、术后住院时间、失血量、手术时间和切缘。
腹腔镜手术组的术后并发症发生率为 19%，开腹手术组为 31%（12 个百分点差异[95%置信区间 1.67-21.8；P = 0.021]）。腹腔镜手术的术后住院时间更短（53 对 96 小时，P < 0.001），但失血量、手术时间和切缘无差异。90 天死亡率与腹腔镜组（0 例）与开腹组（1 例）无显著差异。从 4 个月的角度来看，成本相等，而腹腔镜手术组患者比开腹手术组患者获得 0.011 个质量调整生命年（P = 0.001）。
在接受结直肠癌肝转移实质保留肝切除术的患者中，与开腹手术相比，腹腔镜手术术后并发症明显减少。与开腹手术相比，腹腔镜切除术具有成本效益，概率为 67%。两组的无瘤切缘率相同。我们的结果支持继续实施腹腔镜肝切除术。
