Department of Surgery, The Chinese University of Hong Kong, Hong Kong.
Department of Surgery, Prince of Wales Hospital, Hong Kong.
BJS Open. 2023 Jan 6;7(1). doi: 10.1093/bjsopen/zrac166.
Hepatocellular carcinoma is the sixth most common malignancy in the world. Major hepatectomy (resection of greater than or equal to three liver segments) is needed if a tumour is large or close to major blood vessels. Despite low mortality, open major hepatectomy is associated with high rates of tumour recurrence that limits survival. Laparoscopic major hepatectomy has been proposed as an alternative approach with potential oncological benefits. This study compares laparoscopic major hepatectomy with open major hepatectomy for hepatocellular carcinoma in a randomized trial.
The Asia-Pacific multicentre randomized trial of laparoscopic versus open major hepatectomy for hepatocellular carcinoma (AP-LAPO trial) is an open-labelled multicentre randomized trial to be conducted in five centres in the Asia-Pacific region. The study will test the hypothesis that laparoscopic major hepatectomy for hepatocellular carcinoma is associated with less tumour recurrence and better survival compared with open major hepatectomy; the primary outcome being 2-year recurrence-free survival. Secondary outcomes include hospital mortality, postoperative complications according to the Clavien-Dindo classification, time to functional recovery, quality of life, long-term survival, and postoperative serum surgical stress-related cytokines.
The AP-LAPO trial will determine whether laparoscopic major hepatectomy offers oncological benefits to patients with hepatocellular carcinoma compared with open major hepatectomy.
NCT04852211 (http://www.clinicaltrials.gov) registered on 21 April 2021.
AP-LAPO trial version 01 (1 December 2021).
肝细胞癌是全球第六大常见恶性肿瘤。如果肿瘤较大或靠近主要血管，则需要进行大肝切除术（切除三个或以上肝段）。尽管死亡率较低，但开放性大肝切除术与高复发率相关，限制了生存。腹腔镜大肝切除术已被提出作为一种替代方法，具有潜在的肿瘤学益处。本研究在一项随机试验中比较了腹腔镜大肝切除术与开放性大肝切除术治疗肝细胞癌的效果。
亚太地区腹腔镜与开放性大肝切除术治疗肝细胞癌的多中心随机试验（AP-LAPO 试验）是一项在亚太地区五个中心进行的开放性标签多中心随机试验。该研究将检验假设，即与开放性大肝切除术相比，腹腔镜大肝切除术治疗肝细胞癌与更少的肿瘤复发和更好的生存相关；主要结局是 2 年无复发生存率。次要结局包括住院死亡率、根据 Clavien-Dindo 分类的术后并发症、功能恢复时间、生活质量、长期生存和术后血清手术应激相关细胞因子。
AP-LAPO 试验将确定与开放性大肝切除术相比，腹腔镜大肝切除术是否为肝细胞癌患者提供了肿瘤学益处。
NCT04852211（http://www.clinicaltrials.gov）于 2021 年 4 月 21 日登记。
AP-LAPO 试验版本 01（2021 年 12 月 1 日）。
