Bispebjerg Hospital, Copenhagen, Denmark.
Gastrointest Endosc. 2011 Oct;74(4):876-84. doi: 10.1016/j.gie.2011.06.019.
The self-expandable metal stent (SEMS) can alleviate malignant colonic obstruction and avoid emergency decompressive surgery.
To document performance, safety, and effectiveness of colorectal stents used per local standards of practice in patients with malignant large-bowel obstruction to avoid palliative stoma surgery in incurable patients (PAL) and facilitate bowel decompression as a bridge to surgery for curable patients (BTS).
Prospective clinical cohort study.
Two global registries with 39 academic and community centers.
This study involved 447 patients with malignant colonic obstruction who received stents (255 PAL, 182 BTS, 10 no indication specified).
Colorectal through-the-scope SEMS placement.
The primary endpoint was clinical success at 30 days, defined as the patient's ability to maintain bowel function without adverse events related to the procedure or stent. Secondary endpoints were procedural success, defined as successful stent placement in the correct position, symptoms of persistent or recurrent colonic obstruction, and complications.
The procedural success rate was 94.8% (439/463), and the clinical success rates were 90.5% (313/346) as assessed on a per protocol basis and 71.6% (313/437) as assessed on an intent-to-treat basis. Complications included 15 (3.9%) perforations, 3 resulting in death, 7 (1.8%) migrations, 7 (1.8%) cases of pain, and 2 (0.5%) cases of bleeding.
No control group. No primary endpoint analysis data for 25% of patients.
This largest multicenter, prospective study of colonic SEMS placement demonstrates that colonic SEMSs are safe and highly effective for the short-term treatment of malignant colorectal obstruction, allowing most curable patients to have 1-step resection without stoma and providing most incurable patients minimally invasive palliation instead of surgery. The risk of complications, including perforation, was low.
自膨式金属支架（SEMS）可缓解恶性结肠梗阻，避免紧急减压手术。
根据当地实践标准，记录在患有恶性大肠梗阻的患者中使用结直肠支架的性能、安全性和有效性，以避免不可治愈患者的姑息性造口手术（PAL），并为可治愈患者（BTS）提供肠道减压作为手术桥梁。
前瞻性临床队列研究。
两个全球注册中心，共有 39 个学术和社区中心。
本研究纳入了 447 例患有恶性结肠梗阻的患者，他们接受了支架治疗（255 例 PAL，182 例 BTS，10 例未指明适应证）。
经内镜放置结直肠 SEMS。
主要终点为 30 天临床成功率，定义为患者能够维持肠道功能，且无与手术或支架相关的不良事件。次要终点为操作成功率，定义为支架成功放置于正确位置、持续或复发结肠梗阻的症状，以及并发症。
操作成功率为 94.8%（439/463），基于方案的临床成功率为 90.5%（313/346），基于意向治疗的临床成功率为 71.6%（313/437）。并发症包括 15 例（3.9%）穿孔，其中 3 例导致死亡，7 例（1.8%）迁移，7 例（1.8%）疼痛，2 例（0.5%）出血。
无对照组。25%的患者没有主要终点分析数据。
这是最大的多中心前瞻性结直肠 SEMS 放置研究，表明结直肠 SEMS 是安全且高度有效的，可短期治疗恶性结直肠梗阻，使大多数可治愈的患者无需造口即可进行 1 步切除，并为大多数不可治愈的患者提供微创姑息治疗，而非手术治疗。并发症（包括穿孔）的风险较低。
