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.
RCT Entities:
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.
Authors: Peter S N van Rossum; Nadia Haj Mohammad; Frank P Vleggaar; Richard van Hillegersberg Journal: Nat Rev Gastroenterol Hepatol Date: 2017-12-13 Impact factor: 46.802
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