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.     

Ultraflex precision colonic stent placement as a bridge to surgery in patients with malignant colon obstruction

BACKGROUND: Emergency surgery for malignant colon obstruction entails relatively high morbidity and mortality rates and typically necessitates a 2-step resection. These problems might be potentially mitigated by placement of a self-expanding metal stent (SEMS) as a bridge to surgery. A nitinol colorectal SEMS may offer several advantages, but available evidence on the utility of this SEMS type remains highly limited. OBJECTIVE: Our purpose was to evaluate the effectiveness and safety as a bridge to surgery of a nitinol SEMS designed for colorectal use. DESIGN: Prospective and retrospective multicenter clinical study. SETTING: Sixteen European study centers. PATIENTS: Thirty-six patients with malignant colonic obstruction. INTERVENTIONS: Nitinol colorectal SEMS placement. MAIN OUTCOME MEASURES: Technical success in accurate SEMS placement with coverage of the entire stricture length, clinical success in alleviating colonic obstructive symptoms, and bridging to elective surgery. RESULTS: Technical success was achieved in 97% of patients with a 95% CI of 85% to 100% and clinical success in 81% (95% CI, 64%-92%). Elective surgery was performed in 94% (95% CI, 81%-99%) of patients at a median of 11 days (95% CI, 7-15 days) after SEMS placement. SEMS-related perforation occurred in 3 patients. LIMITATIONS: No control group was included in this nonrandomized cohort study. CONCLUSIONS: In this first comparatively large clinical study of a nitinol colorectal SEMS as a bridge to surgery, a high proportion of patients successfully proceeded to elective surgery after prior decompression by SEMS placement.     

WallFlex colonic stent placement for management of malignant colonic obstruction: a prospective study at two centers

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.     

Comparison of uncovered stent with covered stent for treatment of malignant colorectal obstruction

BACKGROUND: Insertion of self-expandable metallic stents (SEMS) can provide rapid relief of malignant colorectal obstruction and can be used as a palliative treatment or as a bridge to surgery. A SEMS can be classified as an uncovered or covered stent. Both types of stents have their own merits and demerits. OBJECTIVE: The objectives of this study were to compare success rates, durability, and complication rates of uncovered and covered stent groups of malignant colorectal obstruction. DESIGNS AND SETTING: A nonrandomized prospective, single-center study. METHODS: We studied 80 patients with malignant colorectal obstruction: colon cancer in 70 patients, metastatic lesion of advanced gastric cancer in 8 patients, and cervix cancer in 2 patients. Insertion of uncovered stents was attempted in 39 patients (before surgery in 20, palliative in 19), and covered stents were used in 41 (before surgery in 23, palliative in 18). INTERVENTION: The stent was inserted into the obstructive sites for preoperative or palliative purposes by using the through-the-scope method. After stent insertion, the patients had regular follow-ups, either as clinical checkups or telephone interviews. MAIN OUTCOME MEASUREMENT: Insertion success rate, durability, and complication rate according to stent type. RESULTS: Technical and clinical success rates of uncovered and covered stents were not different (100%; 95.1%, P > .05, 100%; 97.4%, P > .05). The early stent migration rate was not different in both groups. The late stent migration was more common in the covered stent group than the uncovered stent group (0% vs 40%, respectively, P = .005). Loss of stent function during the long-term follow-up period was more frequent in the covered stent group than in the uncovered stent group (18.8% vs 60%, respectively, P = .018). LIMITATION: This was a small-sized, nonrandomized, prospective, single-center study. Confirmation of large-scale, multicenter, randomized, prospective outcome is required. CONCLUSIONS: Insertion of either an uncovered or covered stent is similarly an effective treatment modality of malignant colorectal obstruction for preoperative purposes. However, there are no advantages of covered stents over uncovered stents during the follow-up period in the palliative purpose.