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

Abstract

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). To determine the effectiveness and safety of a nitinol SEMS designed for colorectal use in the palliative treatment of malignant colonic obstruction. Prospective multicenter clinical study. Nine European study centers. Forty-four patients with malignant colonic obstruction. Placement of nitinol SEMS designed for colorectal use. 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. 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. This investigation was nonrandomized and did not include a control group. 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.