Gastrointestinal endoscopy · 2009
A fully-covered stent (Alimaxx-E) for the palliation of malignant dysphagia: a prospective follow-up study.
Сравнительное исследованиеСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Uitdehaag Madeleen J, van Hooft Jeanin E, Verschuur Els M L, Repici Alessandro, Steyerberg Ewout W, Fockens Paul, Kuipers Ernst J, Siersema Peter D
Аннотация
BACKGROUND: The majority of the currently available metal stents are partially covered to reduce migration risk. However, one of the remaining issues is tissue ingrowth through the uncovered stent parts.
OBJECTIVE: To determine efficacy, recurrent dysphagia, and complications of a fully covered stent, ie, the Alimaxx-E stent, and to compare two stent delivery systems, ie, one introducing the stent over a guidewire and one introducing the stent over a small-caliber endoscope.
DESIGN: A prospective, follow-up study evaluating a new stent design, with randomization for type of introduction system.
SETTING: Three tertiary referral centers.
PATIENTS: Forty-five patients with inoperable or metastatic esophageal or gastric cardia cancer.
INTERVENTIONS: Stent placement.
MAIN OUTCOME MEASUREMENTS: (1) Functional outcome, recurrent dysphagia, complications, and mortality of the Alimaxx-E stent; (2) functional aspects of the delivery system.
RESULTS: At 4 weeks after stent placement, the dysphagia score improved in all patients (P < .001). Twenty-two of 45 patients (49%) developed among them 28 episodes of recurrent dysphagia, predominantly stent migration (n = 16). Major complications occurred in 9 of 45 patients (20%), with all 5 early (<1 week) complications (severe pain [n = 3], hemorrhage [n = 1], and fever [n = 1]) occurring in patients in whom the stent was introduced over the endoscope (P = .02). During follow-up, 44 patients died, 3 (7%) from hemorrhage.
LIMITATION: The Alimaxx-E stent was not randomly compared with other stent designs.
CONCLUSIONS: Placement of Alimaxx-E stents is safe and produces long-term relief of dysphagia, particularly when introduced over a guidewire. The migration rate of the Alimaxx-E stent is, however, unacceptably high, and an adapted stent design is needed.
OBJECTIVE: To determine efficacy, recurrent dysphagia, and complications of a fully covered stent, ie, the Alimaxx-E stent, and to compare two stent delivery systems, ie, one introducing the stent over a guidewire and one introducing the stent over a small-caliber endoscope.
DESIGN: A prospective, follow-up study evaluating a new stent design, with randomization for type of introduction system.
SETTING: Three tertiary referral centers.
PATIENTS: Forty-five patients with inoperable or metastatic esophageal or gastric cardia cancer.
INTERVENTIONS: Stent placement.
MAIN OUTCOME MEASUREMENTS: (1) Functional outcome, recurrent dysphagia, complications, and mortality of the Alimaxx-E stent; (2) functional aspects of the delivery system.
RESULTS: At 4 weeks after stent placement, the dysphagia score improved in all patients (P < .001). Twenty-two of 45 patients (49%) developed among them 28 episodes of recurrent dysphagia, predominantly stent migration (n = 16). Major complications occurred in 9 of 45 patients (20%), with all 5 early (<1 week) complications (severe pain [n = 3], hemorrhage [n = 1], and fever [n = 1]) occurring in patients in whom the stent was introduced over the endoscope (P = .02). During follow-up, 44 patients died, 3 (7%) from hemorrhage.
LIMITATION: The Alimaxx-E stent was not randomly compared with other stent designs.
CONCLUSIONS: Placement of Alimaxx-E stents is safe and produces long-term relief of dysphagia, particularly when introduced over a guidewire. The migration rate of the Alimaxx-E stent is, however, unacceptably high, and an adapted stent design is needed.