A randomized prospective comparison of self-expandable plastic stents and partially covered self-expandable metal stents in the palliation of malignant esophageal dysphagia

Am J Gastroenterol. 2007 Dec;102(12):2667-77. doi: 10.1111/j.1572-0241.2007.01565.x.

Abstract

Objectives: Self-expanding metal stents (SEMS) provide effective palliation in patients with malignant dysphagia, although severe complications and mortality may result. We performed a prospective controlled trial to compare a new self-expanding polyester mesh stent (Polyflex) with SEMS (Ultraflex).

Methods: One hundred one patients with unresectable esophageal carcinoma were randomized to placement of a Polyflex (N=47) or a partially covered Ultraflex (N=54) stent. Patients with esophagogastric junction (EGJ) malignancy were excluded.

Results: Placement was successful in 46 (98%) patients with the Polyflex and 54 (100%) patients with the Ultraflex stent. In one patient, the Polyflex stent could not be placed. After 1 wk, dysphagia was improved by at least 1 grade in 100% of the Polyflex group and in 94% of the Ultraflex group. Major complications were observed in 48% of the Polyflex group and 33% of the Ultraflex group. Intraprocedural perforation occurred in 1 Polyflex and 1 Ultraflex patient. Two Polyflex patients had postprocedural hemorrhage. Twenty (44%) patients with a Polyflex stent and 18 (33%) with an Ultraflex stent had recurrent dysphagia because of tumor overgrowth, stent migration, hyperplastic granulomatous reaction, or food bolus impaction. Multivariate analysis showed a significantly higher complication rate with Polyflex than with Ultraflex stents (odds ratio 2.3, 95% CI 1.2-4.4). However, median survival was 134 days with Polyflex and 122 days with Ultraflex stents (P=NS).

Conclusions: No difference was seen in palliation of dysphagia between the two stents. Significantly more complications, especially late stent migration, were observed in the Polyflex group.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adenocarcinoma / complications
  • Adenocarcinoma / therapy*
  • Aged
  • Aged, 80 and over
  • Chi-Square Distribution
  • Deglutition Disorders / etiology
  • Deglutition Disorders / therapy*
  • Esophageal Neoplasms / complications
  • Esophageal Neoplasms / therapy*
  • Female
  • Humans
  • Logistic Models
  • Male
  • Metals
  • Middle Aged
  • Palliative Care*
  • Polyesters
  • Prospective Studies
  • Statistics, Nonparametric
  • Stents* / adverse effects
  • Treatment Outcome

Substances

  • Metals
  • Polyesters