Randomized trial of laparoscopic-assisted resection of colorectal carcinoma: 3-year results of the UK MRC CLASICC trial group
Randomized trial of laparoscopic-assisted resection of colorectal carcinoma: 3-year results of the UK MRC CLASICC trial group
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DOI：
10.1200/jco.2006.09.7758
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发表时间：
2007-07-20
影响因子：
45.3
通讯作者：
Brown, Julia M.
中科院分区：
文献类型：
--
作者：
Jayne, David G.;Guillou, Pierre J.;Brown, Julia M.
在英国MRC CLASICC试验的背景下，本研究的目的是报告腹腔镜辅助手术与传统开放手术后的长期结果。随机试验的结果表明，腹腔镜手术治疗结肠癌在短期内与开放手术一样有效。关于直肠癌的数据很少，现在需要关于生存和复发的长期数据。方法英国医学研究委员会（UK Medical Research Council, MRC CLASICC，临床试验编号ISRCTN 74883561）对结直肠癌患者进行常规与腹腔镜辅助手术的比较研究。随机化比例为2:1，支持腹腔镜手术。长期结局（3年总生存期[OS]、无病生存期[DFS]、局部复发和生活质量[QoL]）现在已经在意向治疗的基础上确定。结果共纳入794例患者，其中腹腔镜526例，开放268例。总的来说，长期结果没有差异。生存率的差异为OS为1.8% (95% CI, -5.2%至8.8%,P = 0.55)， DFS为-1.4% (95% CI, -9.5%至6.7%,P = 0.70)，局部复发率为-0.8% (95% CI, -5.7%至4.2%,P = 0.76), QoL（所有量表P = 0.01）。据报道，腹腔镜前切除术（AR）后，环切缘的阳性反应较高，但这并不意味着局部复发率增加。结论成功的腹腔镜辅助结肠癌手术在肿瘤预后和生活质量保存方面与开放手术一样有效。直肠癌患者的长期预后与腹会阴切除术和AR患者相似，支持在这些患者中继续使用腹腔镜手术。
Purpose The aim of the current study is to report the long-term outcomes after laparoscopic-assisted surgery compared with conventional open surgery within the context of the UK MRC CLASICC trial. Results from randomized trials have indicated that laparoscopic surgery for colon cancer is as effective as open surgery in the short term. Few data are available on rectal cancer, and long-term data on survival and recurrence are now required. Methods The United Kingdom Medical Research Council Conventional versus Laparoscopic-Assisted Surgery in Colorectal Cancer ( UK MRC CLASICC; clinical trials number ISRCTN 74883561) trial study comparing conventional versus laparoscopic-assisted surgery in patients with cancer of the colon and rectum. The randomization ratio was 2: 1 in favor of laparoscopic surgery. Long-term outcomes ( 3-year overall survival [ OS], disease-free survival [ DFS], local recurrence, and quality of life [ QoL]) have now been determined on an intention-to-treat basis. Results Seven hundred ninety-four patients were recruited ( 526 laparoscopic and 268 open). Overall, there were no differences in the long-term outcomes. The differences in survival rates were OS of 1.8% ( 95% CI, -5.2% to 8.8%; P = .55), DFS of -1.4% ( 95% CI, -9.5% to 6.7%; P = .70), local recurrence of -0.8% ( 95% CI, -5.7% to 4.2%; P = .76), and QoL ( P = .01 for all scales). Higher positivity of the circumferential resection margin was reported after laparoscopic anterior resection ( AR), but it did not translate into an increased incidence of local recurrence. Conclusion Successful laparoscopic-assisted surgery for colon cancer is as effective as open surgery in terms of oncological outcomes and preservation of QoL. Long-term outcomes for patients with rectal cancer were similar in those undergoing abdominoperineal resection and AR, and support the continued use of laparoscopic surgery in these patients.