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.
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.
Authors: Jong Kyu Park; Moon Sung Lee; Bong Min Ko; Hyung Ki Kim; Young Jee Kim; Hyun Jong Choi; Su Jin Hong; Chang Beom Ryu; Jong Ho Moon; Jin Oh Kim; Joo Young Cho; Joon Seong Lee Journal: Surg Endosc Date: 2010-10-26 Impact factor: 4.584
Authors: Jeffrey H Lee; William A Ross; Raquel Davila; George Chang; E Lin; Alexander Dekovich; Marta Davila Journal: Dig Dis Sci Date: 2010-08-19 Impact factor: 3.199