ABSTRACT
BACKGROUND: Self-expanding metal stents (SEMSs) can alleviate malignant colonic obstruction and avoid emergency decompressive surgery. The use of colonic larger-diameter SEMSs may improve bowel function and reduce migration risk. OBJECTIVE: To evaluate the effectiveness and safety of a novel large-diameter SEMS (WallFlex) designed for delivery through the endoscope in treating malignant colonic obstruction. DESIGN: Prospective clinical cohort study. SETTING: Two Italian study centers. PATIENTS: Forty-two consecutive patients with malignant colonic obstruction: 23 requiring palliation and 19 bridging to surgery. INTERVENTIONS: Colorectal SEMS placement. MAIN OUTCOME MEASUREMENTS: Technical success, defined as accurate SEMS deployment across the stricture on the first attempt; clinical success, ie, complete relief of bowel obstruction without complications; and bridging to surgery, denoting the performance of elective one-stage surgery. RESULTS: The rate of technical success was 93% (95% CI, 81%-99%) and of initial clinical success was 95% (95% CI, 84%-99%). In 58% (95% CI, 40%-84%) of the palliation group, clinical success was maintained after 6 months. All 19 patients with operable tumors were successfully bridged to one-stage elective surgery within a median of 5 days. One perforation and one stent migration occurred. All complications could be resolved nonsurgically. LIMITATIONS: No control group was included. CONCLUSIONS: In a prospective study of through-the-scope WallFlex stent placement for malignant colonic obstruction, high rates of technical and initial clinical success, and bridging to surgery were achieved. Complications could be readily managed.