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

• Published in: Gastrointestinal endoscopy Vol. 74; no. 4; pp. 876 - 884
• Main Authors: Meisner, Søren, MD, González-Huix, Ferran, MD, Vandervoort, Jo G., MD, Goldberg, Paul, MD, Casellas, Juan A., MD, Roncero, Oscar, MD, Grund, Karl E., MD, Alvarez, Alberto, MD, García-Cano, Jesús, MD, PhD, Vázquez-Astray, Enrique, MD, Jiménez-Pérez, Javier, MD
• Format: Journal Article
• Language: English
• Published: Maryland heights, MO Mosby, Inc 01-10-2011; Elsevier
• Subjects: Aged; Biological and medical sciences; Colonoscopy; Colorectal Neoplasms - complications; Colorectal Neoplasms - surgery; Digestive system. Abdomen; Endoscopy; Female; Gastroenterology and Hepatology; Gastroenterology. Liver. Pancreas. Abdomen; Humans; Intestinal Obstruction - etiology; Intestinal Obstruction - therapy; Intestinal Perforation - etiology; Investigative techniques, diagnostic techniques (general aspects); Male; Medical sciences; Palliative Care; Stents - adverse effects; BTS; palliation (incurable patients); bridge to surgery (curable patients); American Society of Anesthesiologists Physical Status Classification System; IRB; PAL; self-expandable metal stent; institutional review board; SEMS; ASA; Short term; Human; Toxicity; Rectum; Instrumentation therapy; Colon; Metal; Malignant tumor; Stent; Cancer
• ISSN: 0016-5107; 1097-6779
• DOI: 10.1016/j.gie.2011.06.019

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.