结直肠癌患者传统手术与腹腔镜辅助手术的短期终点（MRC CLASICC试验）：多中心随机对照试验

Short-term endpoints of conventional versus laparoscopic-assisted surgery in patients with colorectal cancer (MRC CLASICC trial): multicentre, randomised controlled trial.

作者信息

Guillou Pierre J, Quirke Philip, Thorpe Helen, Walker Joanne, Jayne David G, Smith Adrian M H, Heath Richard M, Brown Julia M

机构信息

Academic Unit of Surgery, St James's University Hospital, Leeds, UK.

出版信息

Lancet. 2005;365(9472):1718-26. doi: 10.1016/S0140-6736(05)66545-2.

DOI:10.1016/S0140-6736(05)66545-2

PMID:15894098

Abstract

BACKGROUND

Laparoscopic-assisted surgery for colorectal cancer has been widely adopted without data from large-scale randomised trials to support its use. We compared short-term endpoints of conventional versus laparoscopic-assisted surgery in patients with colorectal cancer to predict long-term outcomes.

METHODS

Between July, 1996, and July, 2002, we undertook a multicentre, randomised clinical trial in 794 patients with colorectal cancer from 27 UK centres. Patients were allocated to receive laparoscopic-assisted (n=526) or open surgery (n=268). Primary short-term endpoints were positivity rates of circumferential and longitudinal resection margins, proportion of Dukes' C2 tumours, and in-hospital mortality. Analysis was by intention to treat. This trial has been assigned the International Standard Randomised Controlled Trial Number ISRCTN74883561.

FINDINGS

Six patients (two [open], four [laparoscopic]) had no surgery, and 23 had missing surgical data (nine, 14). 253 and 484 patients actually received open and laparoscopic-assisted treatment, respectively. 143 (29%) patients underwent conversion from laparoscopic to open surgery. Proportion of Dukes' C2 tumours did not differ between treatments (18 [7%] patients, open vs 34 [6%], laparoscopic; difference -0.3%, 95% CI -3.9 to 3.4%, p=0.89), and neither did in-hospital mortality (13 [5%] vs 21 [4%]; -0.9%, -3.9 to 2.2%, p=0.57). Apart from patients undergoing laparoscopic anterior resection for rectal cancer, rates of positive resection margins were similar between treatment groups. Patients with converted treatment had raised complication rates.

INTERPRETATION

Laparoscopic-assisted surgery for cancer of the colon is as effective as open surgery in the short term and is likely to produce similar long-term outcomes. However, impaired short-term outcomes after laparoscopic-assisted anterior resection for cancer of the rectum do not yet justify its routine use.

摘要

背景

腹腔镜辅助结直肠癌手术已被广泛采用，但缺乏大规模随机试验数据支持。我们比较了结直肠癌患者传统手术与腹腔镜辅助手术的短期终点，以预测长期预后。

方法

1996年7月至2002年7月，我们在英国27个中心对794例结直肠癌患者进行了一项多中心随机临床试验。患者被分配接受腹腔镜辅助手术（n = 526）或开放手术（n = 268）。主要短期终点为环周和纵向切缘阳性率、Dukes' C2期肿瘤比例及住院死亡率。分析采用意向性治疗。该试验已被分配国际标准随机对照试验编号ISRCTN74883561。

结果

6例患者（2例[开放手术组]，4例[腹腔镜辅助手术组]）未接受手术，23例患者手术数据缺失（9例，14例）。实际分别有253例和484例患者接受了开放手术和腹腔镜辅助手术治疗。143例（29%）患者由腹腔镜手术转为开放手术。Dukes' C2期肿瘤比例在两种治疗方法间无差异（开放手术组18例[7%]，腹腔镜辅助手术组34例[6%]；差异-0.3%；95%可信区间-3.9至3.4%，p = 0.89），住院死亡率也无差异（13例[5%]对21例[4%]；-0.9%，-3.9至2.2%，p = 0.57）。除直肠癌接受腹腔镜前切除术的患者外，各治疗组切缘阳性率相似。转为其他治疗方式的患者并发症发生率较高。