van Hooft J E, Fockens P, Marinelli A W, Timmer R, van Berkel A M, Bossuyt P M, Bemelman W A
Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands.
Endoscopy. 2008 Mar;40(3):184-91. doi: 10.1055/s-2007-995426.
The introduction of self-expandable metal stents has offered a promising alternative for palliation of malignant left-sided colonic obstruction. This randomized clinical trial aimed to assess whether a nonsurgical policy, with endoluminal stenting, is superior to surgical treatment in patients with stage IV left-sided colorectal cancer and imminent obstruction.
Patients with incurable left-sided colorectal cancer who fulfilled the study criteria were randomly assigned to nonsurgical or surgical treatment. The primary outcome measure was survival in good health out of hospital (World Health Organization performance scores 0 or 1).
A high number of serious adverse events in the nonsurgical arm led to premature closure of the trial. Ten patients were allocated to surgical treatment and 11 patients to nonsurgical palliation. The median survival in good health out of hospital during the first year was 56 days (interquartile range 7.5 - 338.5 days) in the surgical arm vs. 38 days (interquartile range 5.25 - 288.75 days) in the nonsurgical arm (P = 0.68). Eleven adverse events (six perforations) occurred in the nonsurgical arm vs. one adverse event in the surgical arm (P < 0.001). Of the six perforations, two were stent-related because they occurred at the proximal edge of the stent by erosion through a normal colon wall; one was probably stent-related (it was located in the region of the proximal half of the stent); one was a colon blowout; and two were late tumor perforations in patients on chemotherapy.
The unexpected high rate of perforation in the nonsurgical arm might be specifically WallFlex-related or enteral stent-related in patients on chemotherapy and warrants attention.
自膨式金属支架的引入为缓解恶性左侧结肠梗阻提供了一种有前景的替代方法。这项随机临床试验旨在评估对于IV期左侧结直肠癌且即将发生梗阻的患者，腔内支架置入的非手术策略是否优于手术治疗。
符合研究标准的无法治愈的左侧结直肠癌患者被随机分配至非手术或手术治疗组。主要结局指标是出院后健康生存情况（世界卫生组织体能状态评分为0或1）。
非手术组大量严重不良事件导致试验提前终止。10例患者被分配至手术治疗组，11例患者接受非手术姑息治疗。手术组第1年出院后健康生存的中位时间为56天（四分位间距7.5 - 338.5天），非手术组为38天（四分位间距5.25 - 288.75天）（P = 0.68）。非手术组发生11例不良事件（6例穿孔），手术组发生1例不良事件（P < 0.001）。在6例穿孔中，2例与支架相关，因为是通过正常结肠壁侵蚀在支架近端边缘发生；1例可能与支架相关（位于支架近端一半区域）；1例为结肠破裂；2例是化疗患者的晚期肿瘤穿孔。
非手术组意外的高穿孔率可能在化疗患者中与WallFlex支架或肠内支架特别相关，值得关注。
