Perspective Randomized-controlled clinical trial in patients submitted to self-expanding metal stents for colo-rectal cancer with bowel obstruction. Single center experience. Preliminary data

S. Giungato, L. Fazzolari, A. Deluca, R. Palazzo, M. Ferrante, A. Asciano, F. Marangolo, A. Brunetti, D. Gm, C. Dimito, Pepe As
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引用次数: 1

Abstract

Introduction: Since the early 1990s, self- expanding metal stents (SEMS) have been used to treat malignant colonic obstruction. This kind of endoscopic procedure is mostly used for palliative treatment of colo-rectal cancer buti it is also used as “bridge to surgery”. Materials and methods: This perspective randomized-controlled clinical trial was performed from January 2017 to October 2019. We have recruited all patients admitted in our Emergency Hospital with diagnosis of colonic obstruction. All patients submitted to CT-scan. Patients was divided in 3 Groups: Group A (control group, composed by patients submitted only to emergency surgery) were 17; Group B (patients submitted to SEMS positioning and surgery) were 10; Group C (patients submitted to only SEMS positioning) were 14. The same Metal stent was used for all patient submitted to SEMS positioning (Colonic WallflexTM Boston Scientific 9 cm). Results: Analysis of comparison between Group A vs B highlighted statistical significance for diverting stoma performe (p-value: one-tailed 0.00035; two-tailed 0.00075; p<0.001), equal 70,5% of patients (12 out of 17). Also the comparison between Group A and B, in relation of survival rate (13 patients out of 17, equal to 70,58% in Group A and 10 patients out of 10, equal to 100%, in Group B after two years follow-up), statistical significance shows (p-value one-tailed 0.0010; two- tailed; p<0.005). Comparison of Group B plus C (24 patients), submitted to SEMS, shows time procedure was 25,17 minutes (range 10 - 40) and nobody patients showed stent dislocation or bowel obstruction signs after 48 h from endoscopic procedure. 1 case of Tenesmo in rectal SEMS and 2 colonic perforation after 73 days and 15 days (8%). They submitted early food intake. In our clinical controlled trial, even if is a preliminary data, demonstred that SEMS positioning is a the best palliative procedure with high success rate (95,8%) and a good survival. Mean days of hospitalization of 3,4 days. Conclusion: Our clinical randomized trial shows that SEMS positioning is feasibility as palliative therapy for obstructive colo-rectal cancer and it’s safe procedure as “bridge to surgery”. Other patients are ruled but a greater follow-up will be necessary to make our study more effective.
自膨胀金属支架治疗结直肠癌伴肠梗阻的随机对照临床研究。单中心体验。初步的数据
自20世纪90年代初以来,自膨胀金属支架(SEMS)已被用于治疗恶性结肠梗阻。这种内镜手术主要用于结直肠癌的姑息治疗,但也被用作“手术的桥梁”。材料与方法:该前瞻性随机对照临床试验于2017年1月至2019年10月进行。我们招募了所有在我们急诊医院诊断为结肠梗阻的病人。所有患者均行ct扫描。患者分为3组:A组(对照组,仅接受急诊手术的患者组成)17例;B组(接受SEMS定位和手术的患者)10例;C组(仅采用SEMS体位)14例。所有接受SEMS定位的患者均使用相同的金属支架(Colonic WallflexTM Boston Scientific 9 cm)。结果:A组与B组比较,转移造口效果有显著统计学意义(p值:单尾0.00035;双尾0.00075;P <0.001),等于70.5%的患者(17例中的12例)。A组与B组的生存率比较(A组17例患者中有13例,随访2年后为7058%,B组10例患者中有10例,随访2年后为100%),差异有统计学意义(p值单侧0.0010;两个——跟踪;p < 0.005)。B组与C组(24例)进行SEMS的比较显示,手术时间为25,17分钟(范围10 - 40),没有患者在内镜手术48小时后出现支架脱位或肠梗阻迹象。直肠SEMS中Tenesmo 1例,术后73天和15天结肠穿孔2例(8%)。他们提交了早期的食物摄入。在我们的临床对照试验中,即使是初步数据,也证明了SEMS定位是一种最佳的姑息治疗方法,成功率高(95.8%),生存率高。平均住院天数3,4天。结论:我们的临床随机试验表明,SEMS定位作为梗阻性结直肠癌姑息治疗是可行的,是一种安全的“手术过渡”方法。其他患者被控制,但需要更大的随访以使我们的研究更有效。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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