Self-expandable metal stents for relieving malignant colorectal obstruction: short-term safety and efficacy within 30 days of stent procedure in 447 patients

Background: The self-expandable metal stent (SEMS) can alleviate malignant colonic obstruction and avoid emergency decompressive surgery. Objective: 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). Design: Prospective clinical cohort study. Setting: Two global registries with 39 academic and community centers. Patients: This study involved 447 patients with malignant colonic obstruction who received stents (255 PAL, 182 BTS, 10 no indication specified). Intervention: Colorectal through-the-scope SEMS placement. Main Outcome Measurements: 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. Results: 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. Limitations: No control group. No primary endpoint analysis data for 25% of patients. Conclusion: 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. (Gastrointest Endosc 2011;74:876-84.)