Abstract Background Colorectal cancer often presents with obstruction needing urgent, potentially life-saving decompression. The comparative efficacy and safety of endoluminal stenting versus emergency surgery as initial treatment for such patients is uncertain. Methods Patients with left-sided colonic obstruction and radiological features of carcinoma were randomized to endoluminal stenting using a combined endoscopic/fluoroscopic technique followed by elective surgery 1–4 weeks later, or surgical decompression with or without tumour resection. Treatment allocation was via a central randomization service using a minimization procedure stratified by curative intent, primary tumour site, and severity score (Acute Physiology And Chronic Health Evaluation). Co-primary outcome measures were duration of hospital stay and 30-day mortality. Secondary outcomes were stoma formation, stenting completion and complication rates, perioperative morbidity, 6-month survival, 3-year recurrence, resource use, adherence to chemotherapy, and quality of life. Analyses were undertaken by intention to treat. Results Between 23 April 2009 and 22 December 2014, 245 patients from 39 hospitals were randomized. Stenting was attempted in 119 of 123 allocated patients (96.7 per cent), achieving relief of obstruction in 98 of 119 (82.4 per cent). For the 89 per cent treated with curative intent, there were no significant differences in 30-day postoperative mortality (3.6 per cent (4 of 110) versus 5.6 per cent (6 of 107); P = 0.48), or duration of hospital stay (median 19 (i.q.r. 11–34) versus 18 (10–28) days; P = 0.94) between stenting followed by delayed elective surgery and emergency surgery. Among patients undergoing potentially curative treatment, stoma formation occurred less frequently in those allocated to stenting than those allocated to immediate surgery (47 of 99 (47.5 per cent) versus 72 of 106 (67.9 per cent); P = 0.003). There were no significant differences in perioperative morbidity, critical care use, quality of life, 3-year recurrence or mortality between treatment groups. Conclusion Stenting as a bridge to surgery reduces stoma formation without detrimental effects. Registration number: ISRCTN13846816 (http://www.controlled-trials.com).

中文翻译：

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结直肠内镜支架置入试验（CReST）治疗梗阻性左侧结直肠癌：随机临床试验

摘要 背景结直肠癌通常会出现梗阻，需要紧急、可能挽救生命的减压。腔内支架置入术与急诊手术作为此类患者初始治疗的比较疗效和安全性尚不确定。 方法具有左侧结肠梗阻和癌症放射学特征的患者被随机分配使用内窥镜/荧光镜联合技术进行腔内支架置入术，然后在 1-4 周后进行择期手术，或手术减压伴或不伴肿瘤切除。治疗分配是通过中央随机化服务进行的，使用按治疗意图、原发肿瘤部位和严重程度评分（急性生理学和慢性健康评估）分层的最小化程序。共同主要结局指标是住院时间和 30 天死亡率。次要结局是造口形成、支架置入完成率和并发症发生率、围手术期发病率、6个月生存率、3年复发率、资源利用、化疗依从性和生活质量。按意向治疗进行分析。 结果2009年4月23日至2014年12月22日期间，来自39家医院的245名患者被随机分组​​。 123 名分配患者中的 119 名（96.7%）尝试了支架置入术，119 名患者中的 98 名（82.4%）实现了梗阻缓解。对于 89% 接受治愈性治疗的患者，术后 30 天死亡率（3.6%（110 人中的 4 人）与 5.6%（107 人中的 6 人）；P = 0.48）或住院时间没有显着差异（中位数 19 (iqr 11–34) 与 18 (10–28) 天；P = 0.94）支架置入后延迟择期手术和急诊手术之间的时间。在接受潜在治愈性治疗的患者中，接受支架置入术的患者发生造口的频率低于接受立即手术的患者（99 例中的 47 例（47.5%）对比 106 例中的 72 例（67.9%）；P = 0.003）。治疗组之间的围手术期发病率、重症监护使用、生活质量、3 年复发或死亡率没有显着差异。 结论支架置入术作为手术的桥梁可减少造口形成，且不会产生有害影响。注册号：ISRCTN13846816 (http://www.control-trials.com)。