Ultraflex precision colonic stent placement for palliation of malignant colonic obstruction:: a prospective multicenter study

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.