Laparoscopic Versus Open Hemihepatectomy:Interpretation of the ORANGE Ⅱ PLUS Multicenter Randomized Controlled Trial
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 Novem-ber 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,RO 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 hemihepate-ctomy,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.
laparoscopy surgeryhemihepatectomyfunctional recovery timequality of liferandomized con-trolled studyliver neoplasms
NETL
NSTL
万方数据
