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.
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.
Authors: A Ra Choi; Jin Young Yoon; Hyun Jung Lee; Hui Won Jang; Soo Jung Park; Sung Pil Hong; Tae Il Kim; Won Ho Kim; Jae Hee Cheon Journal: Surg Endosc Date: 2013-03-22 Impact factor: 4.584
Authors: Hun Jin Kim; Jung Wook Huh; Wu Seong Kang; Chang Hyun Kim; Sang Woo Lim; Young Eun Joo; Hyeong Rok Kim; Young Jin Kim Journal: Surg Endosc Date: 2013-02-23 Impact factor: 4.584