Ultraflex precision colonic stent placement for palliation of malignant colonic obstruction:: a prospective multicenter study
Ultraflex precision colonic stent placement for palliation of malignant colonic obstruction:: a prospective multicenter study
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DOI：
10.1016/j.gie.2007.03.1042
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发表时间：
2007-11-01
影响因子：
7.7
通讯作者：
Faroux, Roger
中科院分区：
文献类型：
--
作者：
Repici, Alessandro;Fregonese, Diego;Faroux, Roger
背景：许多患者继发于不能手术的结直肠癌而出现梗阻症状，需要姑息治疗。目的：确定镍钛金属支架在恶性结肠梗阻姑息性治疗中的有效性和安全性。设计：前瞻性多中心临床研究。设置：9个欧洲研究中心。患者：44名患有恶性结肠梗阻的患者。干预：放置镍钛自膨胀金属支架用于结直肠。主要观察指标：技术成功，定义为准确部署有足够狭窄覆盖的SEMS，临床成功，定义为在没有介入或严重的器械相关并发症的情况下维持的结肠梗阻症状的减压和缓解。结果：95%的患者获得了技术上的成功，95%的可信区间为85%~99%。6个月后临床成功率81%，95%可信区间69%~96%。6个月生存率为67%，95%可信区间为54%~84%。在86%的死亡者中，临床成功一直维持到死亡。限制：这项研究是非随机的，不包括对照组。结论：在一项大型前瞻性研究中，姑息性放置用于结直肠的镍醇类SEMS具有很高的技术成功率。在低发病率的高比例患者中取得了持久的临床成功。
Background: Many patients who develop obstructive colonic symptoms secondary to inoperable colorectal cancer will require palliative treatment. A minimally invasive and potentially long-lasting approach is placement of nitinol self-expanding metal stents (SEMS).Objective: To determine the effectiveness and safety of a nitinol SEMS designed for colorectal use in the palliative treatment of malignant colonic obstruction.Design: Prospective multicenter clinical study.Setting: Nine European study centers.Patients: Forty-four patients with malignant colonic obstruction.Interventions: Placement of nitinol SEMS designed for colorectal use.Main Outcome Measures: Technical success, defined as accurate SEMS deployment with adequate stricture coverage, and clinical success, defined as decompression and relief of obstructive colonic symptoms maintained without intervention or serious device-related complications.Results: Technical success was attained in 95% of patients, with 95% CI 85%-99%. After 6 months, the rate of clinical success was 81%, 95% CI 69%-96%. Survival at 6 months was 67%, 95% CI 54%-84%. Clinical success was maintained until death in 86% of the nonsurvivors. No perforations or SEMS-related deaths occurred.Limitation: This investigation was nonrandomized and did not include a control group.Conclusions: In a large prospective investigation, palliative placement of a nitinol SEMS designed for colorectal use was accomplished with a high rate of technical success. Durable clinical success was achieved in a high proportion of patients with low morbidity.