| 刘海东,楼丽姝,张宇华.腹腔镜下半肝切除术与开腹半肝切除术多中心随机对照研究——ORANGE Ⅱ PLUS研究解读[J].肿瘤学杂志,2024,30(6):523-529. |
| 腹腔镜下半肝切除术与开腹半肝切除术多中心随机对照研究——ORANGE Ⅱ PLUS研究解读 |
| Laparoscopic Versus Open Hemihepatectomy： Interpretation of the ORANGE Ⅱ PLUS Multicenter Randomized Controlled Trial |
| 投稿时间：2024-06-06 |
| DOI：10.11735/j.issn.1671-170X.2024.06.B012 |
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| 中文关键词: 腹腔镜手术 半肝切除术 功能恢复时间 生活质量 随机对照研究 肝肿瘤 |
| 英文关键词:laparoscopy surgery hemihepatectomy functional recovery time quality of life randomized controlled study liver neoplasms |
| 基金项目: |
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| 中文摘要: |
| 摘 要：肝切除是治疗原发性和转移性肝脏恶性肿瘤的关键治疗方法。既往随机研究已经证实腹腔镜（微创）手术在小范围肝脏切除中的优势，但没有一级证据支持技术更复杂的腹腔镜下半肝切除术的优劣。ORANGE Ⅱ PLUS研究是一项对接受半肝切除的成年患者进行的多中心、随机对照、双盲、优效性临床研究，旨在比较腹腔镜下半肝切除术（腹腔镜组）与开腹半肝切除术（开腹组）对原发性或转移性肝癌的治疗效果。2013年11月至2018年12月，该研究共入组欧洲16家中心的352例患者，其中332例（94.3%）接受了手术（腹腔镜组166例，开腹组166例）。入组条件：年龄≥18岁、体质指数 18～35 kg/m2、美国麻醉医师协会分级<Ⅳ级、有左半肝或右半肝切除指征、同时适合腹腔镜/开腹手术。主要研究终点为功能恢复时间，次要终点包括手术时间、生活质量、手术切缘状况、辅助治疗时间等。两组间主要研究终点功能恢复时间差异有统计学意义（P<0.001），腹腔镜组中位功能恢复时间4天，开腹组中位功能恢复时间5天。两组严重并发症发生率差异无统计学意义（腹腔镜组14.5% vs 开腹组16.9%，P=0.58）。生活质量方面，腹腔镜组的整体健康状况（P<0.001）和身体形象（P<0.001）得分均显著高于开腹组。对于281例（84.6%）癌症患者，两组R0切缘率相似（77.9% vs 84.1%，P=0.14)，腹腔镜组开始辅助治疗时间间隔较短（46.5天 vs 62.0天，P=0.009)。在接受半肝切除术的患者中，与开腹手术相比，腹腔镜组患者术后功能恢复的时间更短；此外，其与更好的生活质量相关。在癌症患者中，腹腔镜组开始接受辅助治疗的时间间隔更短，且没有观察到对癌症预后的不利影响。 |
| 英文摘要: |
| Abstract： Liver resection is a key treatment for primary and metastatic hepatic malignancy. Randomized studies have confirmed the benefit of laparoscopic partial hepatectomy (minimally invasive surgery) ， but there is no high grade evidence to support the use of laparoscopic major hepatectomy. The ORANGE Ⅱ PLUS was a multicenter， randomized controlled， patient-blinded， superiority trial on adult patients undergoing hemihepatectomy， aiming to compare the therapeutic effects of laparoscopic hemihepatectomy (laparoscopic group) and open hemihepatectomy (open group) on primary or metastatic liver cancer. Patients were recruited from 16 hospitals in Europe from November 2013 to December 2018. Of the 352 randomly assigned patients， 332 patients (94.3%) underwent surgery (laparoscopic： n=166， open： n=166) and comprised the analysis population. Eligible patients were adults aged 18 years or older， with a BMI between 18 and 35 kg/m2， an American Society of Anesthesiologists status of <Ⅳ， and an indication for a left or right hemihepatectomy， suitable for both laparoscopic and open approach as decided at the local multidisciplinary tumor board meeting. The primary outcome measure was time to functional recovery. Secondary outcomes included operation time， quality of life (QoL)， and for those with cancer， resection margin status and time to adjuvant systemic therapy. The median time to functional recovery was 4 days for laparoscopic group versus 5 days for open group (P<0.001). There was no difference in major complications (≥grade 3A) between 2 groups (laparoscopic 14.5% vs open 16.9%， P=0.58). Regarding QoL， both global health status (P<0.001) and body image (P<0.001) scored significantly higher in the laparoscopic group. For the 281 (84.6%) cancer patients， R0 resection margin status was similar (laparoscopic 77.9% vs open 84.1%， P=0.14) with a shorter time to adjuvant systemic therapy in the laparoscopic group (46.5 days vs 62.0 days， P=0.009). Among patients undergoing hemihepatectomy， the laparoscopic approach resulted in a shorter time to functional recovery compared with open surgery. In addition， it was associated with a better QoL， and in patients with cancer， a shorter time to adjuvant systemic therapy with no adverse impact on cancer outcomes observed. |
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